API Department (Quality Assessment)
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Assessment policy
CADIFA Guidance
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SECTIONS
General
3.2.S.1.1
3.2.S.1.2
3.2.S.1.3
3.2.S.2.1
3.2.S.2.2
3.2.S.2.3
3.2.S.2.4
3.2.S.2.5
3.2.S.2.6
3.2.S.3.1
3.2.S.3.2
3.2.S.4.1
3.2.S.4.2
3.2.S.4.3
3.2.S.4.4
3.2.S.4.5
3.2.S.5
3.2.S.6
3.2.S.7.1
3.2.S.7.2
3.2.S.7.3
3.2.S.1.2 - Structure
The following information should be provided:
Structural formula, including stereochemical configuration
Molecular formula;
Relative molecular mass.
Quick access
RDC 359
RDC 200
RDC 73
FB6 (V2)
Ph. Eur.
USP
Ph. Int.
