top of page
bhaskar napte
Sep 6, 20247 min read
Common Mistakes in Dossier Preparation and How to Avoid Them
This quick guidance will help you to avoid mistakes in dossier
1,5110
bhaskar napte
Mar 7, 20241 min read
Classification of Hygroscopicity
Hygroscopicity: Hygroscopicity refers to the ability of a substance to absorb moisture from the environment. In the context of...
2,0570
bhaskar napte
Nov 22, 20232 min read
Residual Solvents and Elemental Impurities: Classification & Exposure Limits as per ICH Q3C AND Q3D
Comparison between Residual Solvents and Elemental Impurities for Classification & Exposure Limits as per ICH
2,7685
bhaskar napte
Nov 20, 20232 min read
How to Handle Changes in Monograph?
How to handle changes in drug product's or drug substance's monograph as per USP and EP
7210
bhaskar napte
Nov 15, 20232 min read
Are the Tailing factor, Symmetry factor, and Asymmetry factor the same?
tailing factor assymetry factor and symmtery factor as per USP and EP or Ph. Eur
4,5870
bhaskar napte
Nov 10, 20233 min read
Why resolution and plate number is measured by using peak width at the half height
measurement of plate number and resolution in HPLC analysis
2060
bhaskar napte
Oct 31, 20232 min read
Understanding the FDA's Early Warning System: Field Alert Reports (FAR)
In this article, we will delve into what FAR is, when it is required, the different types of FAR, and when FAR is not necessary.
8551
bottom of page