Question

name the types of impurity present in a substance​

Answer 1

Answer:

IMPURITY SPACE COVERED BY RD&C

1..Polymorph impurities. Phase transformation during manufacturing and storage result in solid state impurities represented by various unwanted polymorphic forms of the drug substance (e.g. Ritonavir). ...

2..Process impurities in drug substance and drug product. ...

3..Genotoxic process impurities.

Answer 2

Answer:

Impurities is defined as an entity of drug substances or drug product that is not chemical entity defined as drug substances an excipients or other additives to drug product.

Common names

United State Pharmacopeia

ICH Terminology