Fingolimod hydrochloride: sphingosine 1-phosphate receptor modulator.
Fingolimod hydrochloride testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.
Fingolimod hydrochloride: 2D structure drawn from the PubChem record (CID 107969).
162359-56-0
C19H33NO2 · HCl
343.93 g/mol
Sphingosine 1-phosphate receptor modulator
Identity: Fingolimod hydrochloride
IUPAC name: 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol;hydrochloride
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 chloride test, assay by HPLC, organic impurities by HPLC, residue on ignition, water content, and microbial enumeration and tests for specified microorganisms. Full testing to the USP Fingolimod Hydrochloride 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 Fingolimod Hydrochloride monograph is available and quoted.
USP material is the hydrochloride salt, and the free base is about 89 percent of the salt weight. The report states which basis the quantity is given on.
Fingolimod has a single substituted benzene ring, so its UV response is modest and detection is done at low wavelength. LC-MS gives a strong signal for identity.
https://pubchem.ncbi.nlm.nih.gov/compound/107969
Identity facts from the USP monograph header for this compound.
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