Description

Dirithromycin is a semi-synthetic macrolide antibiotic derived from erythromycin, known for its extended half-life and potent activity against a range of Gram-positive pathogens. This compound is valued for its enhanced pharmacokinetic profile, offering improved tissue penetration and sustained therapeutic effects. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of advanced antibiotic formulations for respiratory and skin infections.

Application

• Pharmaceutical Active Ingredient (API): Core component in the manufacture of oral antibiotic tablets and capsules.
• Veterinary Medicine: Used in formulations for treating bacterial infections in livestock and companion animals.
• Clinical Research: Serves as a reference standard and key intermediate in pharmacological and microbiological studies.
• Respiratory Infection Therapeutics: Formulated for treating community-acquired pneumonia, bronchitis, and other lower respiratory tract infections.
• Dermatological Preparations: Incorporated into topical creams or ointments for skin and soft tissue infections.
• Antibiotic Resistance Studies: Used as a model compound in research investigating macrolide resistance mechanisms.

Basic Information

Product Name	Dirithromycin
CAS No.	62013-04-1
Molecular Formula	C42H78N2O14
Molecular Weight	835.08 g/mol
Synonyms	Dirithromycin; (9S)-9-Deoxy-11-deoxy-9,11-[imino[2-(2-methoxyethoxy)ethylidene]oxy]erythromycin; LY-237216; Dynabac; Nortron; AS-E 136; 4''-Deoxydirithromycin precursor
EINECS	Contact for details

Quality Control

Our Dirithromycin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identification by IR and NMR spectroscopy, and stringent control of related substances and residual solvents. We provide full traceability and Certificates of Analysis (COA) are available upon request to ensure compliance with your specific project or regulatory requirements (e.g., ICH guidelines).

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 dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details
Microbial Limits	Complies with Ph. Eur. 2.6.12/2.6.13

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