WHITEPAPERS Home / Whitepapers / An Overview of Dissolution Method Development and Validation for Semisolid Dosage Forms An Overview of Dissolution Method Development and Validation for Semisolid Dosage Forms When most of us think of drug product dissolution testing,...

WHITEPAPERS Home / Whitepapers / An Introduction to Dissolution and Available Apparatuses An Introduction to Dissolution and Available Apparatuses Dissolution testing has been a customary United States Pharmacopeia (USP) test for solid oral dosage forms for more than...

WHITEPAPERS Home / Whitepapers / PhotostabilityA Primer on Photostability in the Development of Pharmaceuticals The storage conditions of a drug product can put it under a lot of stress.  Environmental conditions, such as light, can have a huge impact on how well a...

WHITEPAPERS Home / Whitepapers / Nitrosamines Analysis Nitrosamines Analysis Since the FDA’s discovery of nitrosamines impurities, which led to the voluntary recall of valsartan in 2018, the pharmaceutical industry has undertaken a thorough investigation of this class...

WHITEPAPERS Home / Whitepapers / Supplemental Spectroscopic TechniquesUseful for Pharmaceutical Products Supplemental Spectroscopic Techniques Useful for Pharmaceutical Products Because the industry gold standard for drug products analysis is chromatographic based...

WHITEPAPERS Home / Whitepapers / Development of Peptide Mapping Method for Biopharmaceutical Clients Development of Peptide Mapping Method for Biopharmaceutical Clients Peptide mapping is a component of the analytical technologies used within the biopharmaceutical...

WHITEPAPERS Home / Whitepapers / Overcoming challenges associated with USP and USP Overcoming challenges associated with USP ( Microbial Enumeration) and USP ( Specified Microorganism) Testing of Microbiome Based Therapeutic Products Expanding research into the...

WHITEPAPERS Two Approaches to Amino Acid Analysis: A Commercial Kit or ab initio Development Amino acid analysis is a fundamental biochemical technique used for the determination of the amino acid composition or content of proteins and peptides.  It is used for...

WHITEPAPERS Raw Materials Testing Raw materials are an important aspect of manufacturing a high-quality product. In pharmaceutical manufacturing, when raw materials are not tested and verified to be the highest quality, inferior drugs can enter the marketplace....

WHITEPAPERS Effective Execution of the Microbial, Environmental, and Utility Testing in Cleanroom Qualification The commissioning of a cleanroom is a complex and crucial process with many stages that start after the rooms are designed and built. The ultimate goal of...