Description

Clarithromycin CAS NO 81103-11-9 is a semi-synthetic macrolide antibiotic derived from erythromycin. It is a critical active pharmaceutical ingredient (API) valued for its broad-spectrum activity against a wide range of Gram-positive and some Gram-negative bacteria. This compound is essential for pharmaceutical manufacturers producing formulations to treat respiratory tract infections, skin and soft tissue infections, and Helicobacter pylori-associated ulcers. Its enhanced acid stability and bioavailability compared to earlier macrolides make it a preferred choice in antibiotic therapy.

Application

• Pharmaceutical API: Primary use as the active ingredient in tablet, capsule, and oral suspension formulations.
• Respiratory Infection Treatment: Manufacture of medications for bronchitis, pneumonia, and sinusitis.
• Skin and Soft Tissue Infection Therapy: Key component in antibiotics for cellulitis and impetigo.
• Helicobacter Pylori Eradication: Used in combination therapy regimens for peptic ulcer disease.
• Veterinary Pharmaceuticals: Formulated for treating bacterial infections in animals.
• Research and Development: Serves as a reference standard and for the development of new antibiotic derivatives.

Basic Information

Item	Detail
Product Name	Clarithromycin
CAS No.	81103-11-9
Molecular Formula	C38H69NO13
Molecular Weight	747.95 g/mol
Synonyms	6-O-Methylerythromycin; A-56268; TE-031; Klaricid; Biaxin; Clarith; Claribid; Fromilid; Clariwin; Macladin; (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-6-{[(2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}-14-ethyl-12,13-dihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-7-methoxy-3,5,7,9,11,13-hexamethyl-1-oxacyclotetradecane-2,10-dione
EINECS	Contact for details

Quality Control

Our Clarithromycin is manufactured under strict quality management systems. We ensure compliance with major pharmacopeial standards, including USP, EP, and BP monographs. Every batch undergoes comprehensive analytical testing for identity, potency, and purity. Certificates of Analysis (COA) documenting all test results are provided and available upon request to support your regulatory filings and quality assurance processes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a low-humidity environment to prevent degradation. Ensure the storage area is well-ventilated and away from incompatible materials.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on dried basis)
Water (Karl Fischer)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Microbial Limits	Conforms to EP/USP requirements

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.