Atorvastatin calcium: statin (HMG-CoA reductase inhibitor).
Atorvastatin calcium testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.
Atorvastatin calcium: 2D structure drawn from the PubChem record (CID 60822).
134523-03-8
C66H68CaF2N4O10
1155.36 g/mol
Statin (HMG-CoA reductase inhibitor)
Identity: Atorvastatin calcium (anhydrous)
IUPAC name: calcium bis((3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoate)
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 Atorvastatin Calcium monograph covers identity by infrared spectroscopy and calcium by atomic absorption, assay by HPLC, organic impurities and enantiomeric purity by HPLC, propylene glycol content by GC, and water content. Full testing to the USP Atorvastatin Calcium 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 with UV detection for purity and assay, and LC-MS for identity. Full testing to the USP Atorvastatin Calcium monograph is available and quoted.
The calcium salt is sold anhydrous, as a trihydrate or as a propylene glycol solvate. Each has a different weight per mole, so tell us which form is on the label and quantity is reported on that basis.
Under acidic conditions the open acid side chain closes into a lactone. It is a common degradation peak in the HPLC purity profile.
Atorvastatin has two chiral centers. Its mirror-image forms have the same mass, so the monograph uses a chiral HPLC method to measure them.
https://pubchem.ncbi.nlm.nih.gov/compound/60822
Identity facts from the USP monograph header for this compound.
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