Description

Roxithromycin CAS NO 1460313-73-8 is a semi-synthetic macrolide antibiotic derived from erythromycin. It is valued for its enhanced acid stability and improved pharmacokinetic profile, offering a broad spectrum of antibacterial activity. This active pharmaceutical ingredient (API) is essential for manufacturers in the pharmaceutical industry developing oral dosage forms to treat respiratory tract, skin, and soft tissue infections.

Application

• Pharmaceutical API: Primary use as the active ingredient in the formulation of oral tablets, capsules, and suspensions.
• Respiratory Infection Treatment: Key component in medications targeting community-acquired pneumonia, bronchitis, and other upper and lower respiratory tract infections.
• Dermatological Preparations: Used in treatments for skin and soft tissue infections caused by susceptible organisms.
• Generic Drug Manufacturing: Sourcing for the production of generic antibiotic formulations.
• Veterinary Pharmaceuticals: Potential application in veterinary medicine for bacterial infections in animals.
• Clinical Research: Serves as a reference standard or raw material in pharmaceutical R&D and bioavailability studies.

Basic Information

Product Name	Roxithromycin
CAS No.	1460313-73-8
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; 9-{O-[(2-Methoxyethoxy)methyl]oxime}erythromycin; Roxithromycinum; Roxitromicina
EINECS	Contact for details

Quality Control

Our Roxithromycin is manufactured and tested to meet high-purity standards suitable for pharmaceutical applications. Quality assurance protocols align with ICH guidelines and current Good Manufacturing Practices (cGMP). A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results for identity, purity, assay, and specified impurities. We support our partners with the documentation necessary for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference spectrum
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	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Microbial Enumeration	Meets Ph. Eur./USP requirements

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