Azithromycin: macrolide antibiotic (azalide).
Azithromycin testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.
Azithromycin: 2D structure drawn from the PubChem record (CID 447043).
83905-01-5
C38H72N2O12
749.00 g/mol
Macrolide antibiotic (azalide)
Identity: Azithromycin (anhydrous basis)
IUPAC name: (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one
Method for the $250 identity, purity and quantity test: Chromatographic assay, with detection selected for the compound, 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, pH, water content, and loss on drying. Full testing to the USP Azithromycin 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 a chromatographic assay, with detection selected for the compound. Full testing to the USP Azithromycin monograph is available and quoted.
Azithromycin is usually supplied as the dihydrate, and some material is the monohydrate. The hydrate changes the molecular weight, so the assay is reported on the anhydrous basis and water content matters when comparing results to a label.
Azithromycin has no strong chromophore and absorbs only weakly at low UV wavelengths, so the lab uses a detection method suited to the compound.
Common related compounds include azaerythromycin A, desosaminylazithromycin and N-demethylazithromycin, which come from synthesis or degradation. They are separated in the HPLC purity profile and confirmed by mass.
https://pubchem.ncbi.nlm.nih.gov/compound/447043
Identity facts from the USP monograph header for this compound.
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