Quetiapine fumarate: atypical antipsychotic.
Quetiapine fumarate testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.
Quetiapine fumarate: 2D structure drawn from the PubChem record (CID 5281025).
111974-72-2
(C21H25N3O2S)2 · C4H4O4
883.09 g/mol
Atypical antipsychotic
Identity: Quetiapine fumarate
IUPAC name: bis(2-[2-(4-benzo[b][1,4]benzothiazepin-6-ylpiperazin-1-yl)ethoxy]ethanol);(E)-but-2-enedioic 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 and HPLC retention time, assay by HPLC, organic impurities by HPLC, plus residue on ignition and loss on drying. Full testing to the USP Quetiapine Fumarate 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 assay and LC-MS for identity. Full testing to the USP Quetiapine Fumarate monograph is available and quoted.
The salt is a hemifumarate, with two quetiapine molecules for each fumaric acid. Quetiapine base is about 87 percent of the salt weight, which matters when converting an assay result to a label claim stated as base.
Fumaric acid elutes separately from quetiapine and is not counted as an impurity of the drug. The purity result covers quetiapine and its related compounds.
Yes. The tablet is ground and fully extracted, and the result is reported as percent of the label claim.
https://pubchem.ncbi.nlm.nih.gov/compound/5281025
Identity facts from the USP monograph header for this compound.
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