Description

Clindamycin Stearate is a semi-synthetic ester derivative of the lincosamide antibiotic clindamycin, designed to enhance stability and facilitate formulation. This compound is a critical active pharmaceutical ingredient (API) and intermediate, valued for its targeted antibacterial activity against anaerobic bacteria and protozoa. It is primarily required by pharmaceutical manufacturers for the production of oral dosage forms, serving the global healthcare and veterinary medicine industries.

Application

• Primary Active Pharmaceutical Ingredient (API) in oral antibiotic formulations.
• Key intermediate in the synthesis of other clindamycin salts and derivatives.
• Manufacturing of capsules and tablets for human pharmaceutical use.
• Production of veterinary medicinal products for bacterial infections.
• Research and development of novel antibiotic delivery systems.
• Reference standard in analytical and quality control laboratories.

Basic Information

Product Name	Clindamycin Stearate
CAS No.	1123211-70-0
Molecular Formula	C34H63ClN2O6S
Molecular Weight	671.39 g/mol
Synonyms	Clindamycin Octadecanoate; Clindamycin Stearate Salt; (2S,4R)-N-[(1S,2S)-2-Chloro-1-[(2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(methylsulfanyl)oxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide; Stearic Acid Clindamycin Ester; U-28508; Dalacin C Stearate; Cleocin Stearate
EINECS	Contact for details

Quality Control

Our Clindamycin Stearate is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. Certificates of Analysis (COA) documenting identity, purity, and impurity profiles are provided with every shipment. We support compliance with cGMP, ICH Q7 guidelines, and relevant pharmacopoeial standards (USP/EP).

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 desiccants or inert atmosphere packaging.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Microbial Limits	Meets Ph. Eur. / USP criteria

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