Description

Clindamycin Hydrochloride is a semi-synthetic lincosamide antibiotic derived from lincomycin. This compound is critical for its potent activity against a wide range of anaerobic bacteria and certain protozoa. It is an essential active pharmaceutical ingredient (API) primarily required by the pharmaceutical industry for the formulation of injectable and topical antibiotic preparations.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the manufacture of sterile injectable solutions.
• Formulation of topical preparations such as gels, lotions, and creams for treating acne vulgaris and other bacterial skin infections.
• Used in veterinary medicine for the treatment of infections in animals.
• Key component in research and development for studying antibiotic resistance mechanisms and developing new antimicrobial agents.
• Manufacturing of generic pharmaceutical products following pharmacopeial standards (USP/EP).
• Potential use in compounding pharmacies for specialized medication preparations.

Basic Information

Product Name	Clindamycin Hydrochloride
CAS No.	21462-39-5
Molecular Formula	C18H33ClN2O5S·HCl
Molecular Weight	461.48 g/mol
Synonyms	Clindamycin HCl; 7(S)-Chloro-7-deoxylincomycin Hydrochloride; U-28508; Cleocin Hydrochloride; Dalacin C; Clinimycin Hydrochloride; (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 Hydrochloride
EINECS	244-403-1

Quality Control

Our Clindamycin Hydrochloride is manufactured and tested to meet the stringent requirements of major pharmacopeias, including USP and EP monographs. Every batch undergoes comprehensive analytical testing to ensure identity, potency, purity, and the absence of critical impurities. A Certificate of Analysis (COA) documenting all test results is provided with each shipment, and we support audits for cGMP compliance.

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.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 6.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 1.0%; Total impurities ≤ 3.0%
Specific Rotation	+135° to +150°
Bacterial Endotoxins	< 0.6 EU/mg (if for injectable use)
Sterility Test	Sterile (if for sterile formulation)

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