Clemastine fumarate: antihistamine (H1, ethanolamine ether).
Clemastine fumarate testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.
Clemastine fumarate: 2D structure drawn from the PubChem record (CID 5281069).
14976-57-9
C21H26ClNO · C4H4O4
459.96 g/mol
Antihistamine (H1, ethanolamine ether)
Identity: Clemastine fumarate
IUPAC name: (E)-but-2-enedioic acid;(2R)-2-[2-[(1R)-1-(4-chlorophenyl)-1-phenylethoxy]ethyl]-1-methylpyrrolidine
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, and optical rotation, pH and loss on drying. Full testing to the USP Clemastine 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, with LC-MS to confirm identity. Full testing to the USP Clemastine Fumarate monograph is available and quoted.
The monograph defines the material as the fumarate salt, so assay is normally reported on that basis. A clemastine base figure can be calculated from the molecular weights if needed.
Yes. Clemastine has two stereocenters and is the single (R,R) isomer, which is why the monograph includes optical rotation. A standard HPLC purity test does not separate its enantiomer.
LC-MS detects the protonated clemastine molecule. Fumaric acid is a separate small peak and is not part of the clemastine identity result.
https://pubchem.ncbi.nlm.nih.gov/compound/5281069
Identity facts from the USP monograph header for this compound.
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