Application Finder

Ion chromatography (IC) with suppressed conductivity detection has been approved by the U.S. Pharmacopeia (USP) as a validated method to quantify the monofluorophosphate (MFP) content in sodium monofluorophosphate. This Application Note shows that all acceptance criteria for the USP Monograph «Sodium Monofluorophosphate» are fulfilled and the procedure was approved as a validated USP method.

Stannous fluoride gel for pharmaceutical use needs to comply with USP requirements. The actual monograph (USP 42) utilizes two different methods for the identification and the assay. Ion chromatography allows the analysis of these two parameters within a single determination. In the course of the USP monograph modernization, this ion chromatographic approach makes this type of analysis even easier.

Sodium fluoride and phosphoric acid gel for pharmaceutical use need to comply with USP requirements. The actual monograph (USP 42) uses two different methods for the identification and the assay. Ion chromatography allows the measurement of these two parameters within a single determination. In the course of the USP monograph modernization, this ion chromatographic approach makes this type of analysis even easier.

In the course of USP column equivalency tests, the Metrosep A Supp 3 - 250/4.0 is applied for the assay of citric acid/citrate and phosphate according to USP general Chapter <345>. This report shows that the Metrosep A Supp 3 - 250/4.0 column is equivalent to packing L61 required in USP general Chapter <345>.

As an alternative to titration, ion chromatography (IC) with suppressed conductivity detection has been approved by USP as validated method to quantify chloride content in NaCl tablets for solution or oral use.

An ion chromatography (IC) assay with suppressed conductivity detection is the standardized way to accurately quantify phosphate in phosphates compounded injections.

Anticavity pharmaceuticals like sodium fluoride and acidulated phosphate topical solution products require strict quality control. This Application Note outlines the fluoride IC assay as described in the USP Monograph Sodium Fluoride and Acidulated Phosphate Topical Solution.

In severe cases of cyanide poisoning, sodium nitrite is used along with sodium thiosulfate for treatment. This Application Note describes the nitrite ion chromatography assay with the Metrosep A Supp 4 column and suppressed conductivity detection. This column equivalency study was in cooperation with the USP according to the USP General Chapter <621>.

Nitrosamine presence in medicines, even at trace level poses high safety risks to patients (carcinogenic). Nitrosamine formation can be avoided by controlling and monitoring the nitrite concentration in pharmaceutical products and substances. This Application Note describes the analysis of nitrite in duloxetine hydrochloride with ion chromatography (IC).

Nitrosamine formation can be avoided by controlling the nitrite concentration in pharmaceutical products and processes. To monitor nitrosamine formation, sensitive analytical methods such as ion chromatography for the determination of nitrite in pharmaceutical products and substances are essential.

This Application Note demonstrates square wave voltammetry for sensitive, reproducible quantification of paracetamol using a screen-printed electrode and INTELLO.

Determination of ampicillin in raw and pure products through potentiometric titration with Hg(II) using the combined Au electrode. Keyword: Antibiotics

Determination of total penicillin content through potentiometric titration with Hg(II) using the combined Au electrode. Keyword: Antibiotics

Determination of lidocaine in ointments by potentiometric titration with sodium tetraphenylborate using the NIO surfactant electrode.

Determination of tranexamic acid in injection solutions by nonaqueous potentiometric titration with perchloric acid using a glass electrode.

Determination of benzydamine hydrochloride {1-benzyl-3-[3-(dimethylamino)-propoxy]-1H-indazole hydrochloride} in disinfectant solution by potentiometric titration with sodium tetraphenylborate using the NIO surfactant electrode.

Determination of phenylglycine through nonaqueous potentiometric titration with sodium methylate using a special combined glass electrode. Keyword: Antibiotics

Citric acid and oxalic acid are present in many products, such as foods or chemical solvents (e.g., decontamination solutions). Both acids are reducing agents and citric acid is additionally a powerful antioxidant. Due to their mutual impact (buffer effect), a content calculation is only possible with correction factors for each acid. A fast and accurate determination by potentiometric titration using the dEcotrode plus and sodium hydroxide as titrant can be realized in this Application Note.

Determination of acetate, chloride, and phosphate in an infusion solution by potentiometric titration with sodium hydroxide after conversion of the anions to the corresponding acids.

Determination of the antihistamine astemizole in raw products by nonaqueous potentiometric titration with perchloric acid using separate electrodes.

Determination of calcium pantothenate by nonaqueous potentiometric titration with perchloric acid using separate electrodes.

This Application Note details the photometric determination of chondroitin sulfate with 1-hexadecylpyridinium chloride as titrant and with the Optrode (660 nm). The method is in compliance with the Ph. Eur. and the USP.

This Application Note describes the photometric determination of bismuth nitrate using the Optrode (520 nm). The sample is titrated with EDTA solution past the endpoint; xylene-orange is used as the indicator. The method for bismuth nitrate fulfills the directives defined in the Ph. Eur. and the USP.

This Application Note looks at the photometric determination of manganese sulfate using the Optrode (610 nm). Manganese is titrated with EDTA; Eriochrome Black T is used as indicator. The method complies with Ph. Eur. and the USP.

This Application Note describes the photometric determination of zinc sulfate using the Optrode at a wavelength of 610 nm. Complexometric titration of zinc requires EDTA as titrant and Eriochrome Black T as indicator. The method fully complies with Ph. Eur. and USP.

Titrants are normally bought ready to use. However, it is necessary to determine the accurate concentration of your titrant solution on a regular basis using a primary standard. To correct the mentioned variation, a so-called «titer factor» is applied. The titer can be easily and quickly assessed by using the Metrohm brand of autotitrators. Predefined calculation formulas implemented in Metrohm titrators or software, respectively, as well as the automatic storage of the titer factor, makes standardization a simple task.

This Application Note presents a modified time-saving method to determine iodine value (IV) in edible oils based on several standards (EN ISO 3961, ASTM D5554, etc.).

This Application Note describes the titration of acid value and free fatty acids in different edible oils, based on the standards EN ISO 660, USP<401>, and Ph.Eur. 2.5.1.

The hydroxyl number (HN) is an important sum parameter for quantifying the presence of hydroxyl groups in chemicals. As a key quality parameter, it is determined in various substances. For pharmaceutical samples, USP chapter <401> and Ph. Eur. Chapter 2.5.3 describe the determination. However these methods either use toxic pyridine and require refluxing or have long reaction times.In this Application Note, an alternative method according to ASTM E1899 is presented. This method is pyridine-free and does not require refluxing or long reaction times. The determination is performed at room temperature with only a small sample size. The analysis including all preparation steps is performed with a fully automatic OMNIS system. This allows parallel analysis of multiple samples, increasing productivity in the laboratory by 50%.

In accordance with the European Pharmacopoeia, sodium sulfate is determined with the PB ISE.

This Application Note describes the nonaqueous acid-base titration of ketoconazole in accordance with the European Pharmacopoeia. The Solvotrode easyClean was used as the electrode.

The purity of sulfanilamide was determined by means of automatic potentiometric titration using sodium nitrite as the titrant. The solution was spiked with potassium bromide, because bromide ions catalyze diazotization titration.

The composition of salts with laxative and expectorant effects must be determined precisely in medications. The sulfate content is determined using automatic potentiometric titration with EGTA as titrant in accordance with Ph. Eur. 8.0.

Metformin is one the most commonly used drugs for diabetes type 2 belonging to the group of biguanides. This Application Note describes the determination of metformin hydrochloride assay according to USP using acetic anhydride as solvent.

This Application Note details the determination of acid-neutralizing capacity (ANC) in several pharmaceutical samples in compliance with USP<301> standards.

Penicillin and its related antibiotics are used to prevent and treat a number of bacterial infections, such as respiratory tract infections, urinary tract infections, meningitis, etc. It may also be used to prevent group B streptococcal infection in newborns. The β-lactam ring of penicillin binds to the enzyme DD- transpeptidase, which prevents the formation of cross links during cell wall formation of new bacterial cell, i.e., the division of bacterial cells. USP<425> describes a back-titration method to determine the assay of pharmacopeial penicillin antibiotic drugs and their dosage forms by iodometric titration. The method is illustrated by determining the aminopenicillin content in an ampicillin capsule.

Sulfonamides are drugs used to treat allergies and cough. They also have some antifungal and antimalarial activities. USP<451> describes nitrite titration method for the determination of numerous pharmacopeial sulfonamide drugs and their dosage forms as well as of other pharmacopeial drugs with, for example, hydrazide (e.g., in isoniazid) and amine ester groups (e.g., in procaine) or amide derivatives of amino acids.Here, for illustrating the analysis of the latter, the assay of the diagnostic agent aminohippuric acid is described.

Kjeldahl method is used to determine the nitrogen content in organic and inorganic samples. Kjeldahl consists of three steps: digestion, distillation, and titration. During the catalytic digestion step, organic nitrogen is converted into ammonium. Sodium hydroxide is added just before the distillation step for converting ammonium into ammonia. Through steam distillation the latter is transferred into the receiver vessel containing an absorbing agent (e.g., boric acid). Finally, the separated ammonia is titrated against sulfuric acid. Protein content in samples can also be determined from the nitrogen content obtained by Kjeldahl setup. USP describes the titration method to determine nitrogen content in organic products using Kjeldahl nitrogen setup. This Application Note illustrates nitrogen determination in heparin sodium.

Vitamin C, also known as ascorbic acid or L-ascorbic acid, is an essential nutrient involved in the repair of tissues and the enzymatic production of certain neurotransmitters. It is required for the functioning of several enzymes and immune performance, and is also an important antioxidant. This nutrient is found in many foods and is often used as a dietary supplement.USP general chapter <580> describes a titration technique to determine the assay of Vitamin C as ascorbic acid, sodium ascorbate, and calcium ascorbate dehydrate, or their mixture in finished dosage forms as capsules, tablets, and oral suspensions. This Application Note demonstrates the Vitamin C determination in water-soluble vitamin tablets. The methodology can also be applied for oil-soluble vitamin or mineral tablets, as well as oil- and water-soluble vitamin or mineral capsules.

The surface glass test for hydrolytic resistance combined with the glass grains test determines the glass type. The hydrolytic resistance is determined by the quantity of alkali released from the glass under specified conditions. The released alkali is then titrated with hydrochloric acid to a pH value of 5.5.

This Application Note presents a potentiometric titration method for a potassium bicarbonate and potassium carbonate assay meeting all USP General Chapter <1225> requirements.

Sodium hypochlorite and sodium chloride can be effectively use as disinfectant for water and surfaces. The World Health Organization (WHO) recommends, depending on the application, concentrations in disinfectants of 1000 mg/L to 5000 mg/L NaOCl and up to 200 g/L NaCl.This Application Note demonstrates a reliable method to determine the hypochlorite and sodium chloride content in disinfectants by two subsequent argentometric titrations in the range recommended by the WHO.

This Application Note shows the automatic pH adjustment of a mixture of acetonitrile, water and amine using a Metrohm titrator.

Traditional Chinese medicine (TCM) remedies are gaining popularity in other cultures. In some TCM, sulfur dioxide (SO2) is used as a preservative, antioxidant, and disinfectant. The products are treated by sulfurization with SO2 gas. However, sulfur dioxide is a very poisonous gas. Global health authorities have set strict limits for the content of SO2 in products. It is therefore of crucial importance to determine the sulfur dioxide content to comply with these limits. In this well-suited method, the SO2 content in different natural TCM products are analyzed reliably and accurately according to ISO 22590 using the Eco Titrator equipped with an Optrode and sodium hydroxide as titrant.

Sodium lactate is a salt form of lactic acid used in many regulated industries—therefore an accurate determination of the lactate content is required and is already covered in several norms. One such monograph by the US Pharmacopoeia (USP) results in high accuracies and well-defined titration curves but uses titrants and solvents that are more costly than necessary. In comparison, the presented modified method from Metrohm requires a 1:1 mixture of water and acetone and uses aqueous hydrochloric acid as titrant, resulting in an estimated cost reduction of 40% per titration compared to the USP method (USP–NF 2021, Issue 2). Furthermore, the time needed for each analysis is reduced to just 12% of the USP method (excluding blank determination). This Application Note presents both methods to determine lactate content and shows the results obtained on an OMNIS system.

This Application Note presents a complementary method that allows a consecutive determination after the sample preparation (digestion) of both metal ions in one beaker with an optical sensor and xylenol orange as an indicator.

Mannitol content determination is an important aspect of quality control in the pharmaceutical and food industries. Selective oxidative cleavage can be used to quantify the amount of 1,2-diol groups in the analyte. Determining the 1,2-diol content by iodometric titration can be fully automated for the most accurate results using an automated titrator and the dPt Titrode from Metrohm.

Direct titration is a simple and precise way to accurately measure the caffeine content in different nonaqueous products. The OMNIS Titrator equipped with a dSolvotrode reliably determines caffeine through flexible analyses combined with high-end software.

The iodometric back titration is a precise method used to accurately measure the caffeine content in various aqueous samples. Reliable determinations are made easy using the OMNIS Titrator equipped with a dPt Titrode.

The amine value is an important parameter and quality indicator to determine in chemical processes and pharmaceuticals. This Application Note presents the nonaqueous perchloric acid titration of triethanolamine.

Determination of nickel, zinc, iron(II), and manganese in lithium bromide using cation chromatography with UV/VIS detection (520 nm) after post-column reaction.

Determination of glycolic and lactic acid in the presence of N-methyl pyrrolidone used in drug delivery systems using ion-exclusion chromatography with UV/VIS detection.

Determination of N-acetylcysteine and phenylalanine in tablets against sinusitis by anion chromatography with UV/VIS detection according to USP.

Determination of cefazolin in accordance with USP 28-NF 23 (Appendix 2) using RP chromatography and subsequent UV detection. Keyword: Antibiotics

Determination of salicylic acid and acetylsalicylic acid according to USP 28-NF 23 (second supplement) using RP chromatography with UV detection.

Determination of cloxacillin sodium in accordance with USP 28-NF 23 (Appendix 2) using RP chromatography and subsequent UV detection. Keyword: Antibiotics

Determination of amoxicillin in accordance with USP 28-NF 23 (Appendix 2) using RP chromatography and subsequent UV detection. Keyword: Antibiotics

Determination of theophylline and theobromine according to USP 28-NF 23 (second supplement) using RP chromatography with UV detection.

Determination of valerophenone and ibuprofen according to USP 28-NF 23 (second supplement) using RP chromatography with UV detection.

Determination of thiamine hydrochloride according to USP 28-NF 23 (second supplement) using RP chromatography with UV detection.

Determination of ranitidine hydrochloride according to USP 28-NF 23 (second supplement) using RP chromatography with UV detection.

Determination of penicillin G potassium and 2-phenyl acetamide in accordance with USP 28-NF 23 (Appendix 2) using RP chromatography and subsequent UV detection. Keyword: Antibiotics

Determination of cefadroxil in accordance with USP 28-NF 23 (Supplement 2) using RP chromatography with UV detection. Keyword: Antibiotics

The determination of amino acid is an important task in pharmaceutical and biochemical applications. A binary gradient separates in this example 17 amino acids of a commercially available standard solution. The post-column reaction with ninhydrin requires a temperature of 120 °C, while the samples need to be cooled for stability.

Paracetamol is an effective antipyretic and analgesic. Its determination in tablets using reverse phase chromatography and UV detection is quick and easy with the sample preparation described in this Note. The 815 Robotic Soli Prep for LC does everything automatically: from dissolving the tablets, homogenizing and filtering, to 250-nL-Loop injection.

Aluminum (as gel or salt) is used in vaccines as an adjuvant. This helps to get a stronger immune response. The amount of aluminum in vaccines is regulated e.g., by USP. According to USP maximum amounts of Al3+ in a vaccine dose lay between 0.85 and 1.25 mg. This work describes the determination of aluminum as the 8-hydroxyquinoline complex by ion chromatography with UV/VIS detection.

Manufacturers and laboratories must use validated methods to determine the zinc content in skin care products and pharmaceutical supplements to meet strict quality standards set by the United States Pharmacopeia and National Formulary (USP-NF). USP-NF has updated the zinc monograph (General Chapter <591>, Zinc Determination) and replaced the existing identification procedure of titration with ion chromatography (IC). The analysis involves separating Zn using a Metrosep A Supp 10 column followed by post-column reaction using 4-(2-pyridylazo)resorcinol and detection at 530 nm.

Determination of zinc in a herbal pharmaceutical drug against cancer of the prostate.

Determination (after digestion) of zinc, cadmium, lead, copper, nickel, and cobalt in fabrication powder of vitamin tablets.

Determination of manganese, iron, and molybdenum (after digestion) in fabrication powder of vitamin tablets.

Determination of clothiapine in a pharmaceutical standard.

Determination of artemisinin and artesunate in a standard.

The concentration of Pd in pharmaceutical products is determined by polarography after wet digestion.

Determination of ß-propiolactone in vaccine.

Determination of ascorbic acid (vitamin C) in vitamin capsules after sample digestion.

Thiomersal (also called thimerosal) is a mercury containing organic molecule that has been widely used as preservative for vaccines and eye drops. It is very effective, even in very low concentrations, against a wide range of microorganisms and viruses. To reduce the risk for consumers the maximum concentration of mercury in the products is limited by the authorities. Polarography or voltammetry can be used to accurately determine the concentration of thiomersal in vaccines or other cosmetic and pharmaceutical solutions (such as eye drops). The method is simple to perform, specific, and free of interferences.

Determination of cysteine and cystine in an infusion solution.

Accurate determination of Fe(II) and Fe(III) in water is crucial for many industries. Cathodic sweeping voltammetry (CSV) offers a robust, cost-effective solution.

Riboflavin (vitamin B2) can be determined in vitamin preparations at the DME.

Nicotinamide (vitamin B3, vitamin PP) can be determined in vitamin preparations at the DME.

Iron sucrose injection is a dark brown liquid which contains sucrose and iron(III) hydroxide in an aqueous solution, commonly used for the treatment of iron deficiency anemia. As a medical product, iron sucrose is subject to strict controls. Among other tests, the U.S. Pharmacopeia (USP) requires to monitor the limit of Fe(II) in the iron sucrose injection solution by polarography. The benefit of polarography is that Fe(II) and Fe(III) show signals at different potentials, and therefore an easier determination of Fe(II) without a previous separation of the two oxidation states is possible. The 884 Professional VA together with the viva software allows a straightforward determination of the Fe(II) content of iron sucrose injection solution following the requirements of the USP. The Fe(II) content is automatically calculated and stored in a database together with all relevant determination and calculation parameters.

Sodium pertechnetate (99mTc) radiopharmaceuticals are widely used in medical imaging diagnostic procedures to help diagnose a large number of diseases affecting the bones and major organs. These radiopharmaceuticals are usually prepared from cold kits consisting of several ingredients, including a reducing agent. Sn(II) is a typical reducing agent which reduces the Tc(VII) that is added to the cold kit to a lower oxidation state which then forms the stable organic complex.For quality control, the tin content has to be determined in the kit vial. Sn(II) can be selectively determined using differential pulse polarography. Polarography is a straightforward, sensitive, selective, and interference-free method for the determination of mg/L levels of Sn(II) in radiopharmaceuticals.

Accurate iodine determination in thyroid tablets, ensuring treatment efficacy, is achieved using the 884 Professional VA and Multi-Mode Electrode pro per USP guidelines.

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.

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.

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.

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.

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.

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.

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.

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.

Content uniformity of solid dosage forms can be done nondestructively at the process line using the QTRam portable transmission Raman system.

Allowing non-destructive chemical identification through opaque materials, award-winning STRam represents an evolution in Raman technology.

This article describes the investigation using ion chromatography and subsequent inductively coupled plasma mass spectronomy (ICP/MS) to determine the extent to which the iron(III) flocculation carried out in the context of wastewater treatment releases toxic gadolinium(III) ions as the result of recomplexing.

On the basis of the experiments that have been performed, it is possible to determine the effectiveness of the ozonization of iodized X-ray contrast media using IC-ICP-MS via the amount of iodate formed. Whereas a 120-minute ozonization guarantees a practically quantitative decomposition of amidotrizoic acid to iodate, approximately 16% of the Iomeprol is still present under the same ozonization conditions. Given that only 14% is present in iodate form in the absence of iodide anions and given that additional, not yet identified peaks occur in the ion chromatogram, the presence of additional decomposition products containing iodine must be assumed. Nonetheless, it is not possible to detect the intact iodized X-ray contrast media with the selected ion chromatographic conditions. Furthermore, the possibility exists of identifying the peak of the unknown decomposition product of the Iomeprol using IC-ESI-TOF-MS.

The coupling of ion chromatography and inductively coupled plasma mass spectrometry (ICP/MS) leads to a high-performance measurement system that masters several particularly challenging analyses. It enables for example reliable determination of element compositions, oxidation states and chemical bonds. This information is used, for example, for assessing the toxicity of medications, environmental and water samples as well as foods and beverages.

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.

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

Ion chromatography is a flexible technique with a large selection of intended uses in the pharmaceutical industry. – A few development trends and the latest advances are displayed here.

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.

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.

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.

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>.

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.

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.

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.

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.

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.

High-Performance Liquid Chromatography (HPLC) and Ion Chromatography (IC) are commonly used in the pharma, food, and environmental sectors to analyze samples for specific components and to verify compliance with norms and standards. However, users of HPLC may run into the limitations of this technique, e.g., when analyzing standard anions or certain pharmaceutical impurities. This white paper outlines how such challenges can be overcome with IC.

Polymeric sample vials are frequently contaminated with leachable organic or inorganic ions, which originate from the production process or the raw material. These substances can falsify measurement results. The study at hand compares the leaching properties of several vial types from different manufacturers, showing considerable variations in quality and proving the importance of the right choice of vials for ion chromatography (IC). This white paper also provides recommendations and precautions to further reduce leachable contaminants for IC trace analysis.

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%.

With significant global viral outbreaks becoming the norm rather than generational outliers, it is imperative that fast, sensitive, and cost-effective testing is available to the masses. Screen-printed electrodes (SPEs) allow rapid, widespread testing of populations for infectious disease, without the need of skilled personnel or burdensome equipment in the field. The possibility of point-of-care (POC) testing with SPEs has been exhibited in several recent studies. Metrohm DropSens combines high production capabilites of custom-made SPEs with a valid ISO 13485 certification "Manufacturing of sensors for medical devices", meaning testing procedures developed on these SPEs can be reliably scaled up for larger operations, with easier regulatory approval for commercialization.

Ion measurement can be conducted in several different ways, e.g., ion chromatography (IC), inductively coupled plasma optical emission spectrometry (ICP-OES), or atom absorption spectroscopy (AAS). Each of these are well-established, widely used methods in analytical laboratories. However, the initial costs are relatively high. In contrast, ion measurement by the use of an ion-selective electrode (ISE) is a promising alternative to these costly techniques. This White Paper explains the challenges which may be encountered when applying standard addition or direct measurement, and how to overcome them in order for analysts to gain more confidence with this type of analysis.

This white paper summarizes the steps involved in converting an existing manual titration procedure to semi-automated or automated titration procedures. It discusses topics such as selecting the right electrode and titration mode. For a better understanding, the discussion topics are illustrated with three examples.

Ion chromatography mass spectrometry (IC-MS) is a powerful tool that can handle many challenging analytical tasks which cannot be performed adequately by IC alone. IC-MS is a robust, sensitive, and selective technique used for the determination of polar contaminants like inorganic anions, organic acids, haloacetic acids, oxyhalides, or alkali and alkaline earth metals. After separation of the sample components via IC, mass selective detection guarantees peak identity with low detection limits. The inclusion of automated Metrohm Inline Sample Preparation (MISP) allows not only water samples, but also chemicals, organic solvents, or post-explosion residues to be readily analyzed without need for extensive manual laboratory work. This White Paper explains the benefits of IC-MS over IC in certain cases, the hyphenation of IC and different MS systems, as well as related norms and standards.

The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. Recommendations for the validation of analytical methods can be found in ICH Guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology and in USP General Chapter <1225> Validation of Compendial Procedures. The goal of this white paper is to provide some recommendations for the validation of titration methods.

Haemophilus influenzae type B (Hib) is a major cause of bacterial meningitis in children in many countries. The capsular polysaccharide (PS) of Hib plays an important role in the virulence of the organism. The polysaccharide capsule hides cell surface components from elements of the mammalian immune system, such as antibodies and complement proteins that otherwise would activate mechanisms to kill the pathogen. Vaccines require rigorous characterization and assays to ensure final product quality and consistency. For glycoconjugate vaccines, it is important to measure both free and total PS to ensure the quality. A large amount of unconjugated PS may suppress immunity to the antigen. Additionally, the presence of free PS is a key indicator of process consistency. Current methods to determine PS content in vaccines such as Hib are imprecise and unreliable, especially if the vaccine contains a sugar stabilizer (e.g. lactose). Ion chromatography with pulsed amperometric detection (IC-PAD, or HPAEC-PAD) offers a simpler procedure and better sensitivity than other assays to quantify PS (here, polyribosylribitol phosphate [PRP]) in Hib vaccine.

With Hydranal™ NEXTGEN FA reagents, the water content in ketones can be determined quickly and reliably. Compared to other existing KF reagents for ketones on the market, the side reactions are measurably better suppressed.

This White Paper will walk you through the selection process of ion chromatography as the best analytical tool in the product development of a cell-based gene therapy.

The USP and FDA started to modernize several monographs and General Chapters. In many cases, IC-focused methods have replaced older, wet chemistry procedures. Learn more about the USP modernization initiative and the advantages of ion chromatography in this white paper.

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.

This White Paper discusses USP <1225> and how ion chromatography determines active ingredients in pharma products (assays) as well as identifies impurities and degradation components.

OMNIS Client/Server boosts business performance with scalable server management, cutting costs by reducing hardware, energy use, and maintenance across locations.