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Erythromycin is a broad-spectrum macrolide antibiotic used for the treatment of various bacterial infections, including respiratory tract infections, skin infections, and sexually transmitted diseases. It inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing bacterial growth and replication.
Bluepill Express manufactures high-purity Erythromycin API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and compliance with pharmacopoeial standards (IP, BP, USP, EP). The API is ideal for tablet, capsule, and oral suspension formulations for both domestic and international pharmaceutical markets.
Therapeutic Uses
- Respiratory infections: Bronchitis, pneumonia, and pertussis
- Skin and soft tissue infections: Acne, cellulitis, and impetigo
- Gastrointestinal infections: Helicobacter pylori eradication
- Sexually transmitted infections: Chlamydia and syphilis (alternative therapy)
- Prophylaxis: Prevention of bacterial endocarditis in at-risk patients
Mechanism of Action
Erythromycin binds to the 50S subunit of bacterial ribosomes, inhibiting translocation during protein synthesis. This action is bacteriostatic at lower concentrations and bactericidal at higher concentrations, effectively controlling a wide spectrum of Gram-positive and some Gram-negative bacteria.
Pharmacological Information
- Chemical Name: (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione
- Molecular Formula: C37H67NO13
- Molecular Weight: 733.93 g/mol
- CAS Number: 114-07-8
- Therapeutic Class: Macrolide Antibiotic
- Pharmacological Class: Antibacterial / Protein Synthesis Inhibitor
- ATC Code: J01FA01
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Practically insoluble in water; soluble in ethanol, methanol, and chloroform |
| Melting Point | 155°C – 157°C |
| pH (1% aqueous solution) | 6.0 – 8.0 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 95.0% (HPLC) |
| Loss on Drying | ≤ 1.0% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 2.0% (individual impurity) |
| Bulk Density | 0.40 – 0.55 g/mL |
| Tapped Density | 0.55 – 0.70 g/mL |
Applications
Erythromycin API is used in:
- Tablet, capsule, and oral suspension formulations
- Topical creams and ointments for skin infections
- Veterinary antibiotic formulations
- Combination antibiotic therapies
- Bulk pharmaceutical preparations for global export
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry dates, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
