Shandong Huashang Chemical Co., Ltd. is a high-tech enterprise focused on industry of fine chemicals research and develop, produce and sale. Shandong Huashang Chemical Co., Ltd. is located in Shan Dong Ji Nan China. we have the ability to provide you high quality products. More than 90 % of our products are exported to developed countries and regions such as north America, Europe, Japan, South Korea and the Middle East.
1. Basic Product Profile
- Full IUPAC Name: (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one
- Aliases: Azithromycin, Azithral, Zithromax
- CAS Number: 83905-01-5
- EINECS: N/A
- Molecular Formula: C38H72N2O12
- Molecular Weight: 748.99
- Chemical Classification: Macrolide broad-spectrum antibacterial API, azalide antibiotic raw material
- Core Advantages
Second-generation macrolide azalide antibiotic with methyl-substituted nitrogen on lactone ring. Broader antibacterial spectrum than erythromycin, covers Gram-positive, partial Gram-negative bacteria, mycoplasma, chlamydia; long half-life, once-daily oral administration, low gastrointestinal irritation. Complies with USP/EP/BP pharmacopoeia standards, manufactured for tablets, capsules, dry suspensions, injections for human and veterinary anti-infection treatment.
2. Physical & Chemical Properties
2.1 Physical Index
- Appearance: White or off-white crystalline powder
- Odor: Odorless, slightly bitter taste
- Solubility: Slightly soluble in water; freely soluble in ethanol, methanol, chloroform, acetone; insoluble in aliphatic hydrocarbons
- Melting Point: 113–115 °C
- Specific Optical Rotation [α]D20: -37° ~ -42° (c=1, chloroform)
- Aqueous suspension pH: 9.0–11.0 (weak alkaline)
- Hygroscopy: Slightly hygroscopic under high humidity environment
2.2 Chemical Properties
- 15-membered azalide lactone skeleton containing dimethylamino sugar and neutral desosamine sugar side chains
- Alkalic amino group: Reacts with organic/inorganic acids to form azithromycin salts (azithromycin dihydrate, azithromycin citrate)
- Antibacterial mechanism: Inhibits bacterial ribosomal protein synthesis to block microbial reproduction
- Acid & Alkali Stability: Stable under neutral and weak alkaline conditions; easy to degrade under strong acidic heating, lactone ring hydrolyzes
- Thermal Stability: Slow decomposition above 100 °C, related impurities increase at high temperature
- Photostability: Slightly sensitive to strong UV light; long-term light exposure causes yellowing
- Compatibility: Compatible with neutral pharmaceutical excipients; incompatible with concentrated mineral acids, strong oxidants
3. Main Application Fields
3.1 Human Pharmaceutical API (Core Usage)
- Treatment of respiratory tract infections: pharyngitis, tonsillitis, bronchitis, community-acquired pneumonia;
- Genitourinary tract infection therapy for chlamydia trachomatis, mycoplasma urealyticum;
- Skin soft tissue infection, otitis media, sinusitis oral and injectable preparation raw material.
3.2 Veterinary Antibacterial Raw Material
Antibiotic for livestock, poultry and aquatic animal bacterial and mycoplasma infectious diseases.
3.3 Pharmaceutical Reference Standard
HPLC standard substance for related substance inspection of azithromycin bulk drug and finished preparations.
3.4 Synthetic Intermediate
Precursor for developing novel macrolide anti-resistant bacterial derivatives.
4. Quality Specification Table
| Test Item | Standard Index |
| CAS No. | 83905-01-5 |
| Molecular Formula | C38H72N2O12 |
| Molecular Weight | 748.99 |
| Appearance | White crystalline powder |
| HPLC Assay | Pharma Grade ≥98.0%; Reference Standard ≥99.5% |
| Single Maximum Unknown Impurity | ≤0.10% |
| Total Related Substances | ≤0.80% |
| Moisture Content (KF) | Anhydrous ≤0.50%; Dihydrate 4.5%–6.5% |
| Heavy Metals (Pb) | ≤10 ppm |
| Arsenic (As) | ≤3 ppm |
| Residue on Ignition | ≤0.10% |
| Bulk Package | 25kg light-proof aluminum foil lined fiber drum |
| Sample Package | 1g / 10g / 100g sealed light-proof aluminum foil bag |
| Storage Requirements | Hermetic, light-proof cool dry warehouse ≤25℃; isolate humid air and acidic raw materials |
| Transportation Rule | Macrolide antibiotic API; light-proof moisture-proof sealed packaging required during transit |
| Shelf Life | 36 months under intact light-proof sealed packaging |
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