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) Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and 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 […]
July 2, 2020

Dexamethasone, Potential treatment on Covid-19

Structure of Dexamethasone IUPAC Name: (8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one Dexamethasone is a synthetic adrenal corticosteroid with potent anti-inflammatory properties or immunosuppressive properties and ability to penetrate the CNS. It […]
July 1, 2020
Thermogravimetric Analysis

Thermogravimetric Analysis in Pharmaceuticals

The terms Thermogravimetric Analysis (TGA) describe an experimental method whereby changes in mass are used to detect and to measure the chemical and, less frequently, the […]
July 1, 2020

Forced Degradation Studies for Drug Substances & Drug Products- Scientific Considerations

Introduction – Forced degradation or stress testing is commenced to determine specificity when developing stability-indicating methods, particularly when little information is available about potential degradation 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 […]
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