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Documentation

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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

5-Dehydroxy (3S)-Atorvastatin

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Catalogue No.:	VE0026789
CAS No.:	N/A
Mol. Formula:	C33H35FN2O4
Mol. Weight:	542.6 g/mol

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Additional information on

Parent drug

Atorvastatin

IUPAC Name

(5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-5-hydroxyheptanoic acid

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

O=C(C1=C(C(C)C)N(CC[C@H](O)CCCC(O)=O)C(C2=CC=C(F)C=C2)=C1C3=CC=CC=C3)NC4=CC=CC=C4

InChI

InChI=1S/C33H35FN2O4/c1-22(2)31-30(33(40)35-26-12-7-4-8-13-26)29(23-10-5-3-6-11-23)32(24-16-18-25(34)19-17-24)36(31)21-20-27(37)14-9-15-28(38)39/h3-8,10-13,16-19,22,27,37H,9,14-15,20-21H2,1-2H3,(H,35,40)(H,38,39)/t27-/m1/s1

Description

5-Dehydroxy (3S)-Atorvastatin impurity is a process-related dehydroxylated analog that can form during atorvastatin API synthesis or storage. Characterization requires orthogonal techniques including LC-MS for mass confirmation, HPLC-UV for quantification and stability-indicating profiles, and NMR and chiral chromatography to verify structural and stereochemical integrity. Control strategies focus on synthetic route optimization, targeted purification, validated in-process controls and well-defined specification limits consistent with ICH Q3A guidelines. Risk assessment addresses potential effects on potency, dissolution and patient safety with impurity qualification or toxicological assessment when levels exceed reporting thresholds. Routine monitoring and validated analytical methods ensure batch-to-batch consistency and regulatory compliance.