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 |