Clopidogrel bisulfate: antiplatelet (thienopyridine).
Clopidogrel bisulfate testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.
Clopidogrel bisulfate: 2D structure drawn from the PubChem record (CID 115366).
120202-66-6
C16H16ClNO2S · H2SO4
419.90 g/mol
Antiplatelet (thienopyridine)
Identity: Clopidogrel bisulfate
IUPAC name: methyl (2S)-2-(2-chlorophenyl)-2-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetate;sulfuric acid
Method for the $250 identity, purity and quantity test: HPLC-UV purity and assay, LC-MS identity, against a reference standard, with results in 3 to 5 business days.
The USP monograph covers identity by infrared spectroscopy, HPLC retention time and a sulfate test, assay by HPLC, organic impurities by HPLC, clopidogrel related compound C (the R-enantiomer) by chiral HPLC, residue on ignition, and loss on drying. Full testing to the USP Clopidogrel Bisulfate monograph is available and quoted.
Chromatographic purity and mg per unit by the method matched to the compound, identity against a reference standard. 1 unit.
| Add-on test | Price |
|---|---|
| Identity and impurities | |
| FTIR identity | $90 |
| CHNS elemental analysis (carbon, hydrogen, nitrogen, sulfur) | $125 |
| Chiral purity (where a chiral method exists; new methods quoted) | $250 |
| Water, solvents and salt form | |
| Water content by Karl Fischer | $60 |
| Residual solvents | $150 |
| Counterions: chloride, acetate and TFA | $70 |
| Assay | |
| Assay, % w/w (with raw powder purity; $250 together) | +$50 |
| Metals and conformity | |
| Heavy metals: arsenic, cadmium, chromium, mercury and lead | $150 |
| Conformity: purity and quantity on more units from the same lot | $100 per extra unit |
| Microbiology (injectables) | |
| Endotoxin | $210 |
| Sterility or bioburden | $150 |
| Container closure integrity (CCI) | $50 |
| Screening | |
| Fentanyl screen | $50 |
10% off for 10 or more samples.
Need something else? Other tests are available on request.
Purity and quantity is $250 per sample (1 unit) and raw powder purity is $200 for 50 mg, with results in 3 to 5 business days. Send the material sealed and labeled, with the label claim and the form it contains.
No. The $250 test covers identity, purity and quantity by HPLC-UV for purity and quantity and LC-MS for identity. Full testing to the USP Clopidogrel Bisulfate monograph is available and quoted.
Clopidogrel is the S-enantiomer, and the R-enantiomer is a specified impurity in the monograph. The two have the same mass, so a chiral HPLC method is needed, which is quoted separately from the $250 test.
The methyl ester of clopidogrel hydrolyzes to the clopidogrel carboxylic acid, which is a separate HPLC peak and 14 mass units lighter by LC-MS.
Labels usually state clopidogrel base while the raw material is the bisulfate salt. The result is converted using the molecular weights so it can be compared with the label.
https://pubchem.ncbi.nlm.nih.gov/compound/115366
Identity facts from the USP monograph header for this compound.
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