CLOPIDOGREL BISULFATE

Product Name : CLOPIDOGREL BISULFATE

Molecular Formula :C 16 H 16 ClNO 2 S.H 2 SO 4

Molecular Weight : 419.90

Synonyms : Thieno [3,2-c] pyridine-5(4H)-acetic acid, α-(2-chlorophenyl)-6,7- dihydro, methyl ester, (s)-sulfate (1:1)
Methyl (+)-(s)-α-(0-chlorophenyl)-6,7-dihydrothieno(3,2-c) pyridine-5(4H)-acetate, sulfate (1:1)

CAS No : 120202-66-6


Sr. No. Test Specifications
1 Description White to off-white powder
2 Solubility Freely soluble at pH 1, practically insoluble at neutral pH.
3 Identification
– By IR


– By HPLC



– By Chemically
The IR absorption spectrum of the test preparation should exhibits maxima at the same wavelength as that of a similar preparation of Clopidogrel working standard.

The principal peak in the chromatogram obtained with test solution should correspond to the peak in the chromatogram obtained with the working standard.

Positive test for sulphate (A white precipitate is formed).
4 Organic Impurities (By HPLC, %w/w)

Clopidogrel Related Compound-A
Clopidogrel Related Compound-B
Any Other Impurity
Total impurities


Not more than 0.2
Not more than 0.3
Not more than 0.1
Not more than 0.5
5 Clopidogrel related compound C (By HPLC, %w/w) Not more than 0.5
6 Loss on drying
(at 105°C for 2 hrs, %w/w)
Not more than 0.5
7 Residue on ignition (%w/w) Not more than 0.1
8 Assay (By HPLC, %w/w ODB) Between 97.0 and 101.5
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