Applications
- AN-NIR-002Nondestructive, single tablet analysis using the NIRS XDS RapidContent Analyzer
This Application Note shows the potential of NIRS as a rapid (< 30 s) and nondestructive screening tool for solid dosage forms (e.g. tablets). NIRS requires neither sample preparation nor solvent use. Interferences that derive from scattering are minimized by converting to second derivative spectra.
- AN-NIR-037Determination of polymorphous sulfathiazoles by near-infrared spectroscopy (NIRS)
Sulfathiazoles are sulfonamides with antibiotic effect that occur in various polymorphous forms and that are often used in veterinary medicine. This Application Note shows the differentiation between commercial and sulfathiazole form I using near-infrared spectroscopy (NIRS) with the help of the overtone frequencies of N-H stretching vibration. Form I is the least stable polymorphous form. Crystallization and polymorphism must be monitored as part of quality controls. In this, NIRS is considerably more rapid and more reliable than conventional laboratory methods.
- AN-NIR-011Transferability of a calibration model for caffeine on the NIRS XDS Rapid Content Analyzer
This Application Note demonstrates that a calibration model for caffeine and microcrystalline cellulose developed on the NIRS XDS Rapid Content Analyzer (RCA) is transferable to other NIRS XDS RCA. Due to the improved signal-to-noise ratio, reduced bandwidth and improved wavelength precision of the NIRS XDS, the transferability of the calibration model can be easily and efficiently performed.
- AN-NIR-057Quantification of Baicalin content in scutuellaria baicalensis powder (herbal supplements) by Vis-NIRS
This Application Note shows that visible near-infrared spectroscopy (Vis-NIRS) can be used for the quantification of Baicalin content in herbal supplements. Vis-NIRS is a good alternative to the conventional lab method (HPLC) and can save both cost and time.
- AN-NIR-021Monitoring the purity of recovered solvents with NIRS
The purity of a recovered solvent (dichlormethane/methylene chloride) and two of its most important contaminants (methanol and water) are monitored with NIR spectroscopy.
- AN-NIR-052Simultaneous determination of xanthan gum, optical density, and glucose in aqueous solutions by Vis-NIRS
Near-infrared spectroscopy (NIRS) was used as an analysis method for quality control of aqueous xanthan gum solutions. Quantitative models for the determination of optical density, glucose, and xanthan gum were developed, enabling fast and reliable quality control.
- AN-NIR-063Content uniformity test of pharmaceutical solid dosage forms using NIR spectroscopy
Uniformity of dosage units must be tested for QC purposes in the pharma industry. NIRS gives results in seconds along with the quantification of APIs and excipients.
- AN-NIR-017NIR "predictive model" for the release of pharmaceutical active ingredients from solid dosage forms
This Application Note shows that NIR "predictive models" are optimally suitable for the non-destructive measurement of the release profiles of active ingredients from tablets. This is in accordance with the Process Analytical Technology (PAT) initiative of the FDA. The results demonstrate how NIRS considerably reduces the work involved for release studies in the laboratory.
- AN-NIR-073Determination of water activity in tablets with the OMNIS NIR Analyzer
Water activity is an important parameter to measure for non-sterile pharmaceutical quality and stability. The OMNIS NIR Analyzer provides this data within seconds.
- AN-NIR-066Content uniformity of pharmaceutical solid dosage forms using Vis-NIR spectroscopy examplified on cefixime tablets
This Application Note presents Vis-NIR spectroscopy as a viable alternative to determine API content in cefixime tablets without sample preparation.
- AN-NIR-122Quantification of water in lactose with the OMNIS NIRS Analyzer
This Application Note shows how easy it is to determine water content in the pharmaceutical excipient lactose with reagent-free near-infrared spectroscopy.
- AN-NIR-076Quality control of polyvinyl alcohol
Polyvinyl alcohol (PVA) is a linear polymer, used in a variety of medical products (e.g. eye drops). Here, the degree of alcoholysis is an important index for the water solubility, viscosity, and adhesion of the product. The degree of alcoholysis is defined as the percentage of hydroxyl functional groups compared to the total functional groups accessible in the molecule. Conventional alcoholysis determination can take up to six hours per sample. Compared to the primary method, analysis with near-infrared spectroscopy (NIRS) only takes one minute. The following application note describes the determination of the degree of alcoholysis by NIRS.
- AN-NIR-101Quality control of dried cannabis
Typically, cannabis potency testing is performed by HPLC, but the drawback is that it requires chemicals and it is time-consuming. Near-infrared spectroscopy (NIRS) is a preferred method for quantification of THC, CBD and CBG in dried cannabis because it provides results in less than a minute and does not require any chemicals.
- AN-NIR-042Quantification of USP heparin units using near-infrared spectroscopy
Heparin acts as an efficient anticoagulant and, in addition to direct injection, is also used as a lock-flush solution for rinsing catheters. Vis-NIR spectroscopy can be used to determine the strength of contaminated and purified heparin. This Application Note demonstrates that heparin strength can be determined reliably with Vis-NIR spectroscopy.
- AN-NIR-001Determination of active ingredients in solid (pharmaceutical) dosage forms utilizing solid-state standard additions
Two of the leading pain remedies, aspirin and acetaminophen, are compared with generic samples for content uniformity testing using near-infrared spectroscopy (NIRS). The method of standard addition is used for quantification. To reduce most of the effects that stem from particle size and packing differences, second derivative spectra are used.
- AN-NIR-016Near-infrared spectroscopy for monitoring a single-pot granulator
This Application Note describes the utilization possibilities of a new sensor design that permits, in combination with an NIRS XDS Process Analyzer, the determination of solvent residues in a High-Shear Granulator during the drying phase. This system configuration reduces the scattering of the density distribution of the powder samples so that it is possible, directly in the process, to model the water and solvent content precisely.
- AN-NIR-078Automated moisture analysis in pharmaceutical peptides
The quantification of residual moisture in lyophilized pharmaceutical peptides is an important measure for quality control in the pharmaceutical industry. For development purposes, such measurements are necessary and routinely performed during stability studies and to optimize the freeze-drying process (lyophilization). Currently, Karl Fischer titration is widely used for moisture determination in routine analysis. However, this method is time consuming and destroys the sample during analysis. This Application Note shows that near-infrared spectroscopy (NIRS) is a fast, reagentless, non-destructive method to determine moisture content in lyophilized pharmaceutical products.
- AN-NIR-027Identification of 46 medicinal and aromatic plants for the cosmetics and pharmaceuticals industry
This Application Note shows how, with the help of Vis-NIR spectroscopy and a special plant library, 46 different medicinal and aromatic plants, e.g., Organicum majoricum and Tilia cordata, can be conveniently identified on the basis of their spectrum. In comparison with alternative methods for the determination of plants, which are elaborate and require experienced scientists for their performance, the Vis-NIR method permits rapid and uncomplicated identification.
- AN-NIR-099Quality Control of fermentation broths
Cell fermentation processes are a reliable production method for small molecules and protein-based active pharmaceutical ingredients (APIs). The fermentation process requires monitoring of many different parameters to ensure optimal production. These quality parameters include pH, bacterial content, potency, glucose, and concentration of reducing sugars. Traditional laboratory analysis takes a significant amount of time and requires different analytical techniques to monitor these different quality parameters. Near-infrared spectroscopy (NIRS) offers a faster and more cost-efficient alternative to traditional methods for the determination of critical parameters in fermentation broths at any stage of the fermentation process.
- AN-NIR-020Determination of the water content of soft contact lenses
The determination of the water content of soft contact lenses using NIR spectroscopy is described in this Application. A liquid sample kit with gold diffuse reflector was used for measuring the lenses in transflexion mode. A PLS model was developed for predicting the water content.
- AN-NIR-088Quality Control of CBD oils
Cannabidiol (CBD) is a popular natural remedy from the cannabis plant used in many pharmaceutical, food, and cosmetic products. Unlike tetrahydrocannabinol (THC), CBD is not psychoactive, making it an appealing option for those who are looking for relief from pain and other symptoms without mind-altering effects. CBD oil is made by extracting the cannabinoid from the plant, then diluting it with a carrier oil (e.g., coconut or hemp seed oil). The standard HPLC method requires 45 minutes to perform by highly trained analysts. In contrast to the primary method, Vis-NIR spectroscopy is a cost-efficient and fast analytical solution for the determination of cannabinoid content in edible oils.
- AN-NIR-014Following the progress of pharmaceutical mixing studies using near-infrared spectroscopy
Well-mixed active substances for medications are indispensable in the pharmaceutical industry. This applies not only to the pharmaceutical active ingredient but also for lubricants, binding agents, explosives, oxidants and dyes. Analysis of these active ingredients is expensive; they are also only rarely analyzed as a rule. The progress of the mixing procedures can be followed conveniently with NIR spectroscopy, on the one hand using visual comparisons and on the other by means of spectral algorithms. The progress of mixing processes can be predicted in real time with the help of the spectrum when the latter is used.
- WP-094OMNIS NIRS: An efficiency boost for your laboratory
This White Paper discusses the concept and benefits of NIR spectroscopy and outlines several real-life laboratory application examples with the use of OMNIS NIRS, the cutting-edge NIR spectrometer from Metrohm.
- AN-PAN-1048Inline moisture analysis in a pilot scale granulation process by NIRS
This Process Application Note provides a detailed account of the inline assessment of moisture during a pilot scale granulation process using a 2060 The NIR Analyzer.
- WP-054Boost efficiency in the QC laboratory: How NIRS helps reduce costs up to 90%
Underestimation of quality control (QC) processes is one of the major factors leading to internal and external product failure, which have been reported to cause a loss of turnover between 10–30%. As a result, many different norms are put in place to support manufacturers with their QC process. However, time to result and the associated costs for chemicals can be quite excessive, leading many companies to implement near-infrared spectroscopy (NIRS) in their QC process. This paper illustrates the potential of NIRS and displays cost saving potentials up to 90%.
- WP-040Benefits of Client-Server Systems for Quality Control with Vis-NIR Spectroscopy
Analyzer systems monitoring product quality can offer substantial advantages when organized in a client-server network compared to the more traditional local installation. This white paper presents different client-server setups and their benefits. Security aspects that need to be considered are discussed based on the example of the client-server Vis-NIR (visible near-infrared) spectroscopy software Vision Air, widely used for quality control in the chemical, polymer, pharmaceutical, and petrochemical industry.
- AB-358Analysis of residual moisture in a lyophilized pharmaceutical product by near-infrared spectroscopy (NIRS)
This Application Bulletin describes the method of near-infrared spectroscopy in diffuse reflection for the purpose of determining residual moisture in a lyophilized pharmaceutical product. Numerous sample vials containing freeze-dried pharmaceuticals were spiked with varying amounts of water for calibration purposes. The resulting differences in the absorption wavelengths of the OH-oscillation were correlated with the water content determined by Karl Fischer titration using the algorithm of multiple linear regression (MLR).
- WP-042Data Integrity with NIR-Spectroscopy Software
Data Integrity is currently a hot topic issue that has created much attention and has raised concern within companies working in regulated environments. This White Paper explains some of the key terms used in the context of Data Integrity and outlines how the requirements of Data Integrity can be understood and implemented.
- WP-018FDA 21 CFR Part 11 Requirements for NIR Spectroscopy
This Metrohm White Paper shows the requirements demanded of the pharmaceutical industry by the FDA with respect to software products. Implementation examples of the regulations formulated by the FDA in 21 CFR Part 11 are presented using Vision Air Pharma Software.Key words: electronic signatures, audit trails, user management, documentation
- WP-030Analytical method transfer
Near-infrared spectroscopy (NIRS) is a widely used analytical technique for qualitative and quantitative analysis of various products in research and industrial applications. Because of different reasons it might be necessary to transfer analytical methods from one NIR analyzer to another one. This white paper summarizes the workflow of such method transfer.
- AN-PAN-1050Inline moisture analysis in fluid bed dryers by near-infrared spectroscopy
In the pharmaceutical industry, the fluid bed granulator/dryer is an integral point in the manufacture of powdered materials. Residual moisture must be kept within certain specifications to avoid fracturing of particles or caking (stickiness) of the bulk material. Current methods are slow and cumbersome, which can lead to damaged or degraded product. The ability to monitor the residual moisture content inline after drying is possible with near-infrared spectroscopy (NIRS). The 2060 The NIR Analyzer offers fast, reagent-free, nondestructive analysis of residual moisture of powders with a fluid bed probe specifically designed for these applications.
- AB-410Pharmaceutical analysis using near-infrared spectroscopy
The present Application Bulletin contains NIR applications and feasibility studies using NIRSystems devices in the pharmaceutical industry. Qualitative and quantitative analyses of a wide variety of samples are part of this bulletin. Each application describes the instrument that was originally used for the analysis, as well as the system recommended for the analysis and the results that were achieved thereby.
- 410000030-APortable Transmission Raman Spectroscopy for At-Line Content Uniformity Testing of Pharmaceutical Tablets
Analytical methods to perform CU testing should ideally be fast, noninvasive and achieved with limited sample preparation. Recently, transmission near-infrared (NIR) spectroscopy and transmission Raman spectroscopy have both been explored as alternative methods for rapid and non-destructive on- and at-line CU testing with no sample preparation. Although quick and nondestructive, transmission NIR spectroscopy suffers from poor chemical selectivity and is sensitive to changes in the testing environment. Transmission Raman spectroscopy combined with chemometric modeling is quickly emerging as a valued technique for CU testing due to its high chemical specificity, which is particularly useful when dealing with complex pharmaceutical formulations that contain multiple components.
- AN-PAN-1060Inline process monitoring of moisture content in tetrahydrofuran
This Process Application Note presents a method to accurately monitor low levels of moisture in tetrahydrofuran (THF) in «real-time» safely, reliably, and optimally with a 2060 The NIR Analyzer from Metrohm Process Analytics. Due to the hazardous and hygroscopic nature of THF, a single explosion-proof inline process analyzer is the preferred solution for industries to reduce chemical treatment, improve product quality, and increase profits.
- WP-017Near-infrared spectroscopy in pharmacopoeias
The pharmaceutical industry is very likely more comprehensively regulated that any other branch of industry. It therefore requires analytic methods that meet the requirements of regulations while at the same time being practical. This applies in particular for large sample quantities, such as are encountered with incoming goods inspections, for example. It is here that particularly rapid and simple analysis methods are called for which make routine analyses simpler and more efficient. This White Paper describes some of the most important regulations in the pharmaceutical analysis and shows how Vis-NIR spectroscopy can solve analytic problems in the pharmaceutical industry in accordance with regulations.
- 410000046-AQTRam® for Content Uniformity Analysis of Low-Dose Pharmaceutical Tablets
In this note, we use a model drug, acetaminophen, to demonstrate the capability of QTRam® to quantify low concentrations of API in compressed tablets.QTRam® is a compact transmission Raman analyzer designed specifically for content uniformity analysis of pharmaceuticals in solid dosage forms.
- 410000036-ACost & Benefits of Handheld Raman for Quality Control Testing of Incoming Raw Materials in the Pharmaceutical Supply Chain
Handheld Raman solutions have improved the ability to do complete incoming raw material testing quickly without the need for sample preparation. The NanoRam handheld Raman contributes to increased quality testing with a cost-effective technology used at point of receipt, thus minimizing steps to material acceptance, giving a high return on investment (ROI).
- 410000037-AIn-situ Monitoring of a Moisture-Induced Polymorphic Transition using Raman Spectroscopy and Gravimetric Vapor Sorption
The combination of Raman spectroscopy and vapor sorption techniques provides a comprehensive understanding of vapor-solid interactions of pharmaceutical materials as it relates to the structural properties.This paper investigates the in-situ monitoring of a moisture-induced polymorphic transformation (D-mannitol from delta to beta form) using a combined Raman-vapor sorption technique.
- 410000044-AReduced Variable Multivariate Analysis for Material Identification with the NanoRam®-1064
The RVM method requires only a few spectra to make a model and can be quickly developed on the NanoRam-1064. Multivariate analysis of the Raman spectra on handheld Raman instruments provides more robust methodologies for identifying samples.
- AN-RS-031Simplified RMID Model Building
Material verification models with complex algorithms such as Principal Component Analysis (PCA), quasi-infinite parameters, and preprocessing options can be incredibly complex. Each model must be rigorously built, evaluated, and validated before it can be put into routine use. Mira P simplifies material verification for all. With a short, defined user workflow, straightforward results, and a foolproof Operating Procedure-based design, Mira P is already one of the simplest RMID tools available. ModelExpert, in Mira Cal P, does a chemometrician’s work. ModelExpert automatically determines the best model parameters for robust method development. With Mira P and ModelExpert, even non-technical users can achieve better results in a fraction of the time.
- WP-043Instrument Calibration, System Verification, and Performance Validation for Metrohm Instant Raman Analyzers (Mira)
Analytical Instrument Qualification (AIQ) according to the United States Pharmacopeia (USP) ensures that instruments perform as intended and users may have confidence in data quality. As the Pharma industry adopts handheld Raman instruments for incoming materials identification and verification, producers of such systems must provide suitable calibration and validation routines. Upon completion of these tests, end users are assured that all measurements are in accordance with agreed standards at Metrohm Raman, we have sophisticated AIQ routines in place to confirm the quality of your results.
- BWT-4908The Benefits of a High-Performance Handheld Raman Spectrometer for the Rapid Identification of Pharmaceutical Raw Materials
The principles and benefits of Raman are presented in terms of advances that make handheld Raman an integral tool for pharmaceutical manufacturers to comply with incoming material testing requirements. Examples of the NanoRam for positive identification of excipients including celluloses and sugars illustrate the selectivity of Raman.
- 410000039-AQuantitative Analysis of Solutions Using a High Resolution Portable Raman Spectrometer
Ternary mixtures of aqueous sugar solutions are measured and multivariate models of the concentration of analytes developed using BWIQ software.
- 410000043-AHigh Throughput Large Spot Adaptor
Conventional Raman typically has a very small sampling area with a high power density (PD) at the laser focal point on the sample, which means that only a limited portion of a sample is measured, and the result tends to be irreproducible for heterogeneous sample. The high power density may also cause samples to heat up or burn. The large spot adaptor (LSA) for B&W Tek’s handheld Raman products, featuring a much larger sampling area of 4.5 mm in diameter, is designed to overcome these issues.
- WP-023Karl Fischer titration and near-infrared spectroscopy in perfect synergy
Metrohm has shaped moisture analysis for more than half a century. Find out about new developments in water analysis and learn how near-infrared spectroscopy in combination with Karl Fischer titration can increase your sample throughput and boost your productivity.
- WP-038FDA 21 CFR Part 11 Compliance by Metrohm Raman
Norms and Standards 21 CFR Part 11 is the FDA rule relating to the use of electronic records and electronic signatures.Recognizing the increasing impact of electronic media on critical data in regulated environments, the FDA met with members of the pharmaceutical industry in the early 1990s. The pharmaceutical industry and the FDA were interested in how they could accommodate paperless record systems and ensure the reliability, trustworthiness, and integrity of electronic records.
- 410000028-AIdentification of Additives used in the Pharmaceutical and Food Industries with the NanoRam Handheld Raman Spectrometer
Today’s Raman instrumentation is faster, more rugged, and less expensive than previous instrumentation.The design of high performance, portable and handheld devices has introduced the technology to new application areas that were previously not possible with older, more cumbersome instruments. Handheld Raman instruments such as the NanoRam® from B&W Tek are well-suited for pharmaceutical applications such as the testing of raw materials, verification of final products and the identification of counterfeit drugs due to the technique’s extremely high molecular selectivity.
- WP-024Verification, p-values, and Training Sets for the Mira P
This white paper differentiates between methods for identification of unknowns and verification of known materials. The goal of this publication is, ultimately, to inform the user of the capabilities of the handheld Metrohm Raman Mira P system. Best practices for building robust training sets for materials verification with Mira P can also be found here.
- 410000032-APros and Cons of Using Correlation Versus Multivariate Algorithms for Material Identification via Handheld Spectroscopy
The two most common mathematical representations used with handheld Raman spectroscopy as decision-making tools for spectroscopic data: Hit Quality Index (HQI) and significance level (p-value) are presented.
- AB-423Improvement of optical focusing properties in mobile Raman systems for pharmaceutical analysis
This Application Bulletin compares the unique focusing technology of the portable Metrohm Raman system "Mira" with conventional methods. The method described here is called Orbital Raster Scan (ORS). Experiments show the advantages of ORS technology, using determination and quantification of medicines as an example. It improves the reproducibility of the Raman signals from targeted, active, pharmaceutical ingredients (APIs) in effervescent, cold medicines. Shorter analysis times and an improved, consistent assignment of spectra of the known medicine with the help of a spectral library are further advantages of ORS technology.
- AN-RS-010P-test verification of Equate cold tablets and comparison with Alka-Seltzer
Producers of generic brands offer cosmetics, medicines and other goods in competition with name brands, often at a lower price point. This lower cost may reflect a lack of research, development, and advertising costs, but should never imply lower quality, especially in the case of over-the-counter drugs. As an example, Equate (a Walmart brand) effervescent cold tablets promise customers the same active ingredients in the same proportions and with identical effectiveness as Alka-Seltzer, at a much lower price. This Application Note demonstrates that Raman spectroscopy can successfully verify that these competing cold tablets are not identical. The process of ingredient verification involves a p- test, which measures the acceptable variability of a sample spectrum, as compared to a representative training set.
- AN-RS-011Improving verification with Orbital Raster Scan technology
Raman spectrometers use tightly focused beams to produce high resolution spectra, but fail at analyzing heterogeneous substances because they cannot spatially target all components. ORSTM (Orbital Raster Scan) increases the interrogation area on a sample while maintaining high spectral resolution. Effervescent cold medicines, for example, contain many active ingredients in each heterogeneous tablet. Traditional identification and verification techniques require the collection of several spectra at different points on the tablet. Mira spectrometers equipped with ORS capture a large interrogation area in a very short time, analyzing all of the ingredients in a single scan.
- BWT-4913The Versatility of Portable Raman in Process Development
Raman spectroscopy is a well suited spectroscopic technique for process development and control within development laboratories in chemical, pharmaceutical, and other industries. This article demonstrates the utility of portable Raman spectroscopy as a simple and versatile tool for in situ monitoring of reactions using univariate analysis techniques such as peak trending, as well as multivariate analysis approaches to predict the end point of chemical reactions.
- BWT-4915Portable, High-Efficiency Transmission Raman Spectroscopy for At-Line Content Uniformity Testing of Pharmaceutical Tablets
Content uniformity of solid dosage forms can be done nondestructively at the process line using the QTRam portable transmission Raman system.
- 410000026-AFast Ingredient Analysis of Edible Oils Using a Portable Raman Spectrometer
Edible oils are not only a major source of nutrition but also a key basic material in the food industry. Vegetable oils are increasingly important because of their high content in mono- and polyunsaturated fatty acids in comparison with animal fats. In this application note, the main ingredients of olive oil, camellia oil, arachis oil, sunflower seed oil, and colza oil are analyzed using a portable Raman spectrometer combined with chemometrics software.
- BWT-4906Rapid Raw Material Identification for Formulation Compounds Using Handheld Raman Technology
The raw materials whey, sorbitol, stearic acid, and calcium phosphate dihydrate dibasic all show very distinctive, unique Raman signatures, which indicates that Raman spectroscopy is the ideal technology for identification of these materials. The PCA model-based method provides reliable specificity to successfully identify these nondestructively in plastc samples bags using the NanoRam.
- 410000008-ARaw Materials Identification through Multiple Polyethylene Bags
The NanoRam is able to test material through multiple layers of transparent plastic bags. Postive identification of material on PE bags from 1 to 9 layers were obtained, demonstrating minimum interference from the PE bags on the material identification result.
- AN-RS-044Optimize raw material identification and verification (RMID) with MIRA P
This Application Note explains how to scale MIRA P usage across an entire manufacturing operation by transferring models between different MIRA P instruments.
- AN-RS-045Transition RMID Operations Between Handheld Raman Devices
This application shows how to seamlessly transition from Metrohm’s NanoRam 785 to the newer MIRA P system, ensuring continuity in raw material identification (RMID).
- AN-RS-051Rapid detection of illegal adulterants in dietary supplements with Raman
Undeclared drugs in dietary supplements pose serious health risks. Metrohm’s SERS solutions enable fast, sensitive, on-site detection of adulterants without matrix interference
- 410000038-AMaterial ID through Dark Brown PVBag
This technical note is to demonstrate the NanoRam material identification through dark brown plastic bags. NanoRam is shown to work for material identification inside dark brown polyvinyl bag.
- AN-PAN-1065Inline monitoring of cell cultures with Raman spectroscopy
This Process Application Note presents a method to accurately monitor lactic acid and glucose inside a bioreactor in «real-time» with the 2060 Raman Analyzer from Metrohm Process Analytics.
- 410000049-ANanoRam®-1064 Fast Facts: Botanical Verification
Botanicals are derived from plant materials and used for their medicinal and therapeutic properties in the nutraceuticals market. They are not as heavily regulated by the U.S. Food and Drug Administration (FDA) like the pharmaceuticals drug market, but they are required to follow Good Manufacturing Practice (GMP Requirements).The NanoRam®-1064 is an asset for pharmaceutical identity testing, minimizing fluorescence generated by typical handheld Raman systems with 785 nm lasers. As such, the NanoRam®-1064 is used here to identify botanicals that would normally fluoresce with a 785 nm laser.
- 410000029See-through ID with Raman technology
Metrohm’s ST Raman technology enables fast, contactless identification of substances through opaque packaging, expanding safe, field-ready use of Raman spectroscopy.
- 410000040-ASampling Guidelines for Handheld Raman Measurements – What You Need To Know
Handheld Raman is used for raw material testing of different sample types and forms. The use of optimized sampling accessories enhances the utility of handheld Raman without compromising data quality or complicating testing.
- BWT-4903The NanoRam Hand-held Raman Spectrometer: Ideally-suited for the Inspection of Raw Materials and Chemicals Used in the Pharmaceutical industry
The NanoRam handheld Raman, with a TE-cooled spectrometer, and patented CleanLaze technology packaged in a small, touch-screen operating unit, delivers high quality raw material testing capabilities for pharmaceutical manufacturers.
- BWT-4911Using Handheld Raman to Reduce Risks in Materials Used for Manufacturing
Raman spectroscopy is a valuable tool to provide rapid, specific analysis for identification of raw materials, thus reducing the risk of using substandard or incorrect materials in manufacturing. The utility of handheld Raman increases productivity, and the ability to do full testing without creating bottlenecks in the production process. The integration of the Raman data into a company’s data management system provides a secure means of handling data and results, with reduced risk of transcription errors, and data loss.
- BWT-4916See-Through Science
Allowing non-destructive chemical identification through opaque materials, award-winning STRam represents an evolution in Raman technology.
- 410000014-BRaman Spectroscopy as a Tool for Process Analytical Technology
This article demonstrates the utility of portable Raman spectroscopy as a versatile tool for process analytical technology (PAT) for raw material identification, in-situ monitoring of reactions in developing active pharmaceutical ingredients (APIs), and for real-time process monitoring. Raw material identification is done for verification of starting materials as required by PIC/S and cGMP, and can be readily done with handheld Raman. Portable Raman systems allow users to make measurements to bring process understanding and also provide proof of concept for the Raman measurements to be implemented in pilot plants or large-scale production sites. For known reactions which are repetitively performed or for continuous online process monitoring of reactions, Raman provides a convenient solution for process understanding and the basis for process control.
- 410000017-ARaman for See Through Material Identification Application Note
A new Raman system design is presented that expands the applicability of Raman to See Through diffusely scattering media such as opaque packaging materials, as well as to measure the Raman spectrum and identify thermolabile, photolabile, or heterogeneous samples.
- BWT-4914Raman Spectroscopy Peers Through Packaging
Patented STRaman technology is a new Raman technique that can identify chemical species nondestructively beneath diffusely scattering packaging material such as plastics or tablet coatings.
- WP-037Simplifying quality control using Near-Infrared Spectroscopy
Quality control is impacted by multiple challenges, which can have an influence on the functioning of the QC lab. The present White Paper provides approaches, how to simplify the daily quality control using near-infrared spectroscopy combined with a dedicated smart software like Vision Air.
- BWT-4905The NanoRam Hand-held Raman Spectrometer Full Regulatory Compliance for the Inspection of Raw Materials and Chemicals Used in the Pharmaceutical Industry.
The NanoRam is a state-of-the-art, handheld Raman spectrometer for the rapid identification of chemicals used in the pharmaceutical manufacturing process. It has been specifically designed for these applications and is fully compliant with all the major global regulatory, safety, and commercial testing agencies applicable to the pharmaceutical industry.
- 410000003-APortable Raman Spectroscopy for the Study of Polymorphs and Monitoring Polymorphic Transitions
Raman spectroscopy is used for material characterization by analyzing molecular or crystal symmetrical vibrations and rotations that are excited by a laser, and exhibit vibrations specific to the molecular bonds and crystal arrangements in the molecules. Raman technology is a valuable tool in distinguishing different polymorphs. Examples of portable Raman spectroscopy for identification of polymorphs and in monitoring the polymorphic transiton of citric acid and its hydrated form are presented.
- 410000047-ANanoRam-1064 Fast Fact: Raw Material Verification of Cellulose and its Derivatives
Cellulose is a common naturally-derived raw excipient found in the majority of pharmaceutical products. Raw material testing is required to ensure that consumers are receiving quality cellulose and its derivatives. The NanoRam®-1064 is an asset for pharmaceutical identity testing, minimizing fluorescence generated by typical handheld Raman systems with 785 nm lasers. As such, the NanoRam®-1064 is used here to identify cellulose derivatives that would normally fluoresce with a 785 nm laser.
- 410000061-AIdentification of Starting Materials in Pharmaceutical industry using STRam®-1064
100% starting materials identification testing is one of the FDA’s directives as per 211.84 for FDA regulated industries such as Pharmaceutical, Vaccines, Cosmetics, Tobacco, Animal veterinary products, Food, etc. STRam®-1064 is a Raman analyzer uniquely suited for this purpose. It measures samples through thick packaging materials such as plastics, multilayer kraft paper sacks, and HDPE containers. A long wavelength laser is used to suppress fluorescence. The ID algorithm isolates the sample signature by subtracting that of the packaging material and compares that with library spectra to achieve identification.
- AN-RS-006Differentiation between isopropyl alcohol from various manufacturers
This Application Note shows the rapid, non-destructive identification of isopropyl alcohol from two manufacturers using Raman spectroscopy following the creation of a suitable library. The measurements with the hand-held Raman spectrometer Mira M-1 require no sample preparation and provide immediate results that identify the samples unambiguously.
- WP-031Lifecycle of multivariate methods according to United States Pharmacopeia Chapter <1039> Chemometrics
Chemometrics is a powerful tool widely used for method development in the pharmaceutical industry. This whitepaper describes the lifecycle of multivariate models and summarizes the workflow of the development of chemometrical models according to the new USP chapter <1039>.
- 410000056-ACounterfeit Adderall Pills Identification with TacticID Mobile
In this case study, a suspected counterfeit Adderall pill was measured directly with a TacticID Mobile using a point-and-shoot adapter. The spectra of the suspected couterfeit pill was found to contain cellulose and caffeine, but not the active ingredient. The TacticiD Mobile with 1064-nm laser excitation provides fluorescence suppression, giving those on the front lines a tool in the fight against dangerous counterfeit drugs.
- AN-PAN-1064Monitoring complexing agents in galvanic baths inline with Raman spectroscopy
Accurate analysis of complexing agents in galvanic baths is possible with inline Raman spectroscopy. This Application Note shows an example using a 2060 Raman Analyzer.
- 410000012-A01Rapid Detection of the Low Dose API in Xanax Using Surface-Enhanced Raman Spectroscopy for Anti-Counterfeiting Purposes
The emergence of counterfeit prescription drugs has become a concern for the pharmaceutical industry. Because of the low concentrations of APIs found in pharmaceutical drugs, normal Raman spectroscopy is typically not sensitive enough to detect the API from the surface of a pill. In this study we develop a surface-enhanced Raman spectroscopy (SERS)-based approach to identify a low-dose of the API alprazolam in a Xanax tablet using a handheld Raman spectrometer. If no SERS peaks consistent with alprazolam are observed from a Xanax tablet, the pill is a suspected fake. The method demonstrates the power of SERS to quickly verify the presence of alprazolam in the tablet for anti-counterfeiting purposes.
- AN-RS-048Phosphates speciation with Raman spectroscopy
Metrohm’s MIRA XTR handheld Raman spectrometer enables fast, reagent-free identification of phosphate species, enabling continuous monitoring of dynamic systems.
- AN-RS-055Low-frequency Raman spectroscopy
Low frequency Raman spectroscopy extends conventional Raman analysis by capturing vibrational modes down to 65 cm-1, enabling deeper insights into molecular structure, protein characterization, polymorph identification, and phase changes.
- AN-RS-034Orbital Raster Scan (ORS™)
This application note presents the Orbital Raster Scan (ORS) technology from Metrohm Raman to overcome low resolution, poor sensitivity, and sample degradation while still interrogating a large sample area.
- BWT-4912Quantitative Analysis Using New Generation Raman Spectrometers and Chemometrics ─ Smaller and Faster
Small, fast high-performance Raman spectrometers are now readily available. Three real-life Raman quantitative and semi-quantitative analysis applications are discussed. These applications showcase the versatility of Raman spectroscopy and the potential impact that it can make in various industries such as security, pharmaceutical, and plastics and polymers.
- WP-097Why switch to OMNIS Client/Server (C/S)?
OMNIS Client/Server boosts business performance with scalable server management, cutting costs by reducing hardware, energy use, and maintenance across locations.