There are few common queries related to drug substances in the CMC (Chemistry, Manufacturing, and Controls) section. Here’s an example:
3.2. S DRUG SUBSTANCE
3.2. S.1 General Information
3.2. S.1.1: Nomenclature Section
Queries: 1. USAN, BAN, IUPAC, names, CAS not provided until.
3.2. S.1.2: Structure Section Queries:
Stereochemistry, Isomerism structure and discussion on the drug substance used in the formulation is absent.
3.2. S.1.3: General Properties Section
Queries:
- In the presentation, nature of drug is not discussed. Drug known to be a polymorphic in nature.
- Polymorphism and chirality is not mentioned adequately.
- The physical constants such as solubility in organic solvent, water, buffers at different pH values are poorly described.
- Existence/absence of polymorphism and chirality is not discussed.
- Particle size distribution, Hygroscopicity, granularity, flowability etc. not described in detail.
- A description on solubility based on different pH buffers (pH 1.2, 4.6 & 6.8) not provided.
- pKa value not included in section.
Read also: