Amiodarone hydrochloride: benzofuran antiarrhythmic (iodinated).
Amiodarone hydrochloride testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.
Amiodarone hydrochloride: 2D structure drawn from the PubChem record (CID 441325).
19774-82-4
C25H29I2NO3 · HCl
681.77 g/mol
Benzofuran antiarrhythmic (iodinated)
Identity: Amiodarone hydrochloride
IUPAC name: (2-butyl-1-benzofuran-3-yl)-[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone;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 and a chloride test, assay by HPLC, organic impurities by TLC and HPLC, and an iodide limit by spectrophotometry, residue on ignition, pH and loss on drying. Full testing to the USP Amiodarone 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 with UV detection for purity and assay, and LC-MS for identity. Full testing to the USP Amiodarone Hydrochloride monograph is available and quoted.
Amiodarone carries two iodine atoms, and light or heat can split some of it off as iodide. Free iodide is a sign of degradation, so it is limited separately from the organic impurities.
Yes. It deiodinates in light, giving mono-iodo and de-iodo related compounds that separate by HPLC. Samples should be kept in amber containers.
The USP material is the hydrochloride, and results are reported on that basis unless you ask for the free base (CAS 1951-25-3).
https://pubchem.ncbi.nlm.nih.gov/compound/441325
Identity facts from the USP monograph header for this compound.
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