Rosuvastatin calcium: statin (HMG-CoA reductase inhibitor).
Rosuvastatin calcium testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.
Rosuvastatin calcium: 2D structure drawn from the PubChem record (CID 446157).
287714-41-4
C22H28FN3O6S
481.54 g/mol
Statin (HMG-CoA reductase inhibitor)
Identity: Rosuvastatin (free acid)
IUPAC name: (E,3R,5S)-7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic 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 Rosuvastatin Calcium monograph covers identity by infrared spectroscopy, HPLC retention time and a calcium test, assay by HPLC, organic impurities and enantiomeric purity by HPLC, and water content. Full testing to the USP Rosuvastatin 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 Rosuvastatin Calcium monograph is available and quoted.
Labels usually state the amount as rosuvastatin, while the raw material is the calcium salt, which holds two rosuvastatin units per calcium. Tell us which basis your label uses.
Yes. Light can form degradation products, including a lactone and an oxidized form, which show up in the HPLC purity profile. Keep samples protected from light.
https://pubchem.ncbi.nlm.nih.gov/compound/446157
Identity facts from the USP monograph header for this compound.
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