Leading Macrolide Antibiotic API for Respiratory, STI, and Community-Acquired Infections
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Azithromycin (CAS 83905-01-5) is a semi-synthetic azalide macrolide antibiotic derived from erythromycin, with expanded gram-negative spectrum and significantly enhanced intracellular tissue penetration compared to its parent compound. It inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit at the 23S rRNA, blocking peptidyl transferase and mRNA translocation. Azithromycin's unique pharmacokinetics — 68-hour half-life, high tissue concentrations, and once-daily dosing — make it one of the most prescribed antibiotics globally.
Azithromycin API sourcing requires strict macrolide impurity control per USP, EP, and IP monographs, including azithromycin E-isomer (trans-isomer), descladinose azithromycin, and azithromycin N-oxide, each with specific HPLC limits. The dihydrate form (CAS 117772-70-0) is preferred in most tablet and powder formulations for stability, while the anhydrous form is used in specific dosage forms. Water content by KF (4.0–5.0% for dihydrate) and pH of 1% solution (9.0–11.0) are critical quality parameters.
Swapnroop manufactures Azithromycin API (anhydrous and dihydrate) at our WHO-GMP Aurangabad facility with full USP/EP/IP compliance and validated impurity profiling. Our consistent batch quality, large production volumes, and competitive pricing make us a preferred long-term supplier for antibiotic formulators in India and export markets including Africa, Southeast Asia, and the Middle East.
Azithromycin API is supplied in sealed double-polyethylene-lined fiber drums (25 kg net) with desiccant and nitrogen blanket. Dihydrate grade requires controlled humidity storage (RH 40–60%) to maintain water content specification. Temperature: store at 25°C or below.
Get Bulk QuoteThe CAS number for Azithromycin (anhydrous) is 83905-01-5. The dihydrate form (CAS 117772-70-0) is also available for suspension formulations.
Azithromycin inhibits bacterial protein synthesis by reversibly binding to the 50S ribosomal subunit, blocking translocation of peptidyl-tRNA. Its azalide structure gives extended tissue half-life (68 hours) enabling short-course 3–5 day Z-pack therapy.
Azithromycin Dihydrate contains two molecules of water of crystallisation and is preferred for aqueous oral suspension formulations for its stability in hydrated matrices. Anhydrous form is used for tablet manufacture.
Key impurities include Erythromycin A (macrolide related substance), Azithromycin N-oxide, and other macrolide degradation products. All are controlled per USP/BP specifications with impurity certificate provided.
MOQ is 25 kg for commercial supply. We offer competitive pricing for 100 kg+ with consistent monthly availability for high-volume domestic Indian antibiotic manufacturers.
Swapnroop Drugs and Pharmaceuticals is a trusted Azithromycin API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Azithromycin API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Azithromycin API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Azithromycin API pricing, samples, and sourcing support.