Description

Roxithromycin is a semi-synthetic macrolide antibiotic derived from erythromycin, known for its enhanced acid stability and favorable pharmacokinetic profile. This compound is a critical active pharmaceutical ingredient (API) used in the formulation of effective antibacterial medications. It is primarily required by pharmaceutical manufacturers and research institutions for developing treatments against a wide spectrum of bacterial infections.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral antibiotic formulations, including tablets and capsules.
• Respiratory Tract Infections: Treatment of community-acquired pneumonia, bronchitis, and other upper and lower respiratory infections.
• Skin and Soft Tissue Infections: Effective against bacterial causes of erysipelas, cellulitis, and impetigo.
• Urogenital Infections: Used in the management of non-gonococcal urethritis and cervicitis.
• Research & Development: Serves as a reference standard and key intermediate in antimicrobial research and new drug development.
• Veterinary Medicine: Formulated for treating specific bacterial infections in animals.

Basic Information

Product Name	Roxithromycin
CAS No.	80214-83-1
Molecular Formula	C41H76N2O15
Molecular Weight	837.05 g/mol
Synonyms	Roxithromycin; RU 965; RU-965; Erythromycin 9-[O-[(2-methoxyethoxy)methyl]oxime]; (9E)-9-{O-[(2-Methoxyethoxy)methyl]oxime}erythromycin; Assoral; Claramid; Forilin; Roxar; Roximycin; Rulid; Surlid
EINECS	279-411-2

Quality Control

Our Roxithromycin is manufactured under strict quality management systems, ensuring it meets high-purity standards suitable for pharmaceutical applications. Quality is verified through comprehensive analytical testing, including HPLC, IR, and related substance analysis. A Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with every batch to ensure traceability and compliance with customer and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Keep the container tightly sealed in a dry environment to protect the hygroscopic material from moisture.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 3.0%
Residue on Ignition	≤ 0.2%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Heavy Metals	≤ 20 ppm
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.