Amlodipine besylate: calcium channel blocker (dihydropyridine).
Amlodipine besylate testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.
Amlodipine besylate: 2D structure drawn from the PubChem record (CID 60496).
111470-99-6
C20H25ClN2O5 · C6H6O3S
567.05 g/mol
Calcium channel blocker (dihydropyridine)
Identity: Amlodipine besylate
IUPAC name: benzenesulfonic acid;3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
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, residue on ignition, optical rotation, and water content. Full testing to the USP Amlodipine Besylate 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 Amlodipine Besylate monograph is available and quoted.
The dihydropyridine ring of amlodipine can oxidize to the pyridine form, especially under light. This degradant is a separate HPLC peak and is two mass units lighter by LC-MS.
Labels usually state amlodipine base while the raw material is the besylate salt. The result is converted using the molecular weights so it can be compared with the label.
Most amlodipine is racemic. Levamlodipine, the S-enantiomer, has the same mass and needs a chiral method to tell apart, which is quoted separately.
https://pubchem.ncbi.nlm.nih.gov/compound/60496
Identity facts from the USP monograph header for this compound.
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