Blog
July 7, 2020
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
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
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
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
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
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
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 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
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 […]