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Compendial Testing and Regulatory Guidance

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Showing 1-17 of 17 results
TLC Silica Gel 60 G Plates with Gypsum
TLC plates, with silica gel, gypsum as binder, International Pharmacopoeia compliant, for identification of Atenolol and Chlorthalidone in tablets.
USP HPLC Analysis of L-Methionine on Ascentis® Express OH5
Separation of L-Methionine, Pharmaceutical Secondary Standard; Certified Reference Material
Sterility Testing of Products with Antimicrobial Properties
Steritest® NEO device is ideal for sterility testing of antibiotics. The Steridilutor® NEO system is designed to dissolve and dilute drugs in vials whereas the Steridilutor® NEO device for the liquid transfer kit allows diluting liquids from open ampoules into
Famciclovir Tablets USP Monograph Method Using a Purospher™ STAR RP-8 endcapped HPLC Column and UV Detection
Following the new USP monograph for Famciclovir Tablets, Purospher™ STAR RP-8 endcapped HPLC columns can be used to monitor organic impurities in Famciclovir tablet formulations. Famciclovir is an antiviral drug indicated for the treatment of herpes zoster, herpes simplex virus
Elemental Impurities - Certified Ref. Materials
Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.
Assay of Doxepin Hydrochloride USP Monograph
The FPP Purospher® STAR RP-8e column offers a reliable and consistent assay with strong peak shapes and linearity, ensuring precise quantification.
Determination of Geniposide Forsythin in XiaoerChiqiaoQingre
Analyze Xiaoer Chiqiao Qingre granules for geniposide and forsythin using Discovery® HS C18 column and Supelclean™ LC-Alumina-N SPE.
Determination of Baicalin, Chlorogenic acid and Forsythin
Analyze Shuanghuang Lian oral liquid using Discovery® HS C18 HPLC column per Chinese Pharmacopeia 2020. Quantify baicalin, chlorogenic acid, and forsythin with high accuracy.
The Utility of Headspace Grade Solvents for the Analysis of Organic Volatile Impurities
Learn about analyzing organic volatile impurities (OVIs) in pharmaceuticals using SH-GC, focusing on suitable solvents and ensuring compliance.
Ultrapure Water for Trace Element Analysis in Pharmaceuticals
Milli-Q® water system produces ultrapure water for ICP-MS and ICP-OES elemental impurity analysis in pharmaceuticals.
Ultrapure Water to Assess Elemental Impurities per USP
Elemental impurities in pharmaceutical drugs present a risk to human health and are regulated. Milli-Q® ultrapure water purification systems comply with the requirements for trace element analyses.
Evaluation of Millex® Syringe Filters for Nitrosamine Impurities Testing in Pharmaceutical Drugs
An overview of nitrosamine impurity testing, worldwide regulations, and key considerations in filter selection for sample preparation and analysis.
Importance of Volumetric Solution Standardization
The titer determination or standardization of a titration solution is essential for accurate and reliable titration results.
Improving USP Lansoprazole Analysis with HPLC
USP methods continuously revised for modernization and improved results in drug testing.
Cell Culture FAQs: Bacterial Endotoxin Contamination
FAQs on bacterial endotoxin contamination, details on endotoxin testing using the LAL assay, and tips to avoid contamination in cell cultures.
Sterility Testing of Products in Isopropyl Myristate
Sterile Isopropyl Myristate (IPM) enhances filterability for sterility testing of viscous products using the Steritest® NEO device.
Ultrapure Water for LC MS Biomedical Analyses
This study assesses the suitability of ultrapure water from a Milli-Q® water system for sensitive LC-MS analyses of hormones.