drug products

July 7, 2020
Nitrosamine impurities traces in Ranitidine

Nitrosamine Impurities Traces in Ranitidine

Introduction Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and […]
July 6, 2020
Nitrosamine impurities -A regulatory perspective

Nitrosamine Impurity: A Regulatory Perspective

Introduction                 The Regulatory agency announced that Nitrosamine impurities N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) are said to be present in generic drug substances and drug product, […]
July 4, 2020
Nitrosamine impurities traces in Metformin

Nitrosamine Impurities Trace in Metformin

Introduction Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. The Regulatory agency announced that traces of Nitrosamine […]
July 3, 2020
GMP Practice Considerations for Responding to COVID 19

Good Manufacturing Practice (GMP) Considerations for Responding to COVID-19 Infection in Employees in Drug & Biological Products Manufacturing

Introduction In June 2020, FDA released Guidance for Industry (GFI) entitled “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products […]
June 29, 2020
Potential Impurities in Drub substance and Drug Products

Potential Impurities in Drug Substance & Drug Products

Potential impurities are the substance which are formed during the reaction or already present in the form of starting materials, by-products, or intermediate products. Potential Impurities […]
June 27, 2020
Forced-degradation for drug products -Regulatory-Considerations

Forced Degradation Studies for Drug Substances and Drug Products- A Regulatory Considerations

Introduction – Various regulatory guidance is available which provides useful definitions and general comments about degradation studies. However, guidance concerning the scope, timing, degradation condition, and […]