Description

Clindamycin Palmitate Hydrochloride CAS NO 36688-78-5 is a semisynthetic lincosamide antibiotic, specifically the palmitate hydrochloride ester salt of clindamycin. This prodrug form is critical for enhancing the oral bioavailability and palatability of the parent compound, making it suitable for pediatric and adult formulations. It is an essential active pharmaceutical ingredient (API) and intermediate primarily required by pharmaceutical manufacturers for producing oral antibiotic suspensions and other dosage forms.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of oral antibiotic suspensions, particularly for pediatric use.
• Antibacterial Formulations: Used in the development and production of solid and liquid dosage forms targeting anaerobic bacteria and Gram-positive aerobes.
• Drug Intermediate: Serves as a key synthetic intermediate in the production of other clindamycin derivatives and specialized antibiotic products.
• Research & Development: Utilized in preclinical and clinical research for studying lincosamide antibiotics, pharmacokinetics, and new antibacterial therapies.
• Veterinary Pharmaceuticals: Incorporated into medicated feeds or treatments for bacterial infections in animals.
• Reference Standard: Serves as a high-purity chemical reference standard for quality control and analytical testing in pharmaceutical laboratories.

Basic Information

Product Name	Clindamycin Palmitate Hydrochloride
CAS No.	36688-78-5
Molecular Formula	C34H63ClN2O6S • HCl
Molecular Weight	699.86 g/mol (as free base)
Synonyms	Clindamycin Palmitate HCl; Clindamycin 3-Palmitate Hydrochloride; 7(S)-Chloro-7-deoxylincomycin 3-palmitate hydrochloride; U-28508; Dalacin C Palmitate; Cleocin Palmitate Hydrochloride; Methyl 7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl]amino]-1-thio-L-threo-α-D-galacto-octopyranoside 3-palmitate hydrochloride
EINECS	Contact for details

Quality Control

Our Clindamycin Palmitate Hydrochloride is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure compliance with relevant pharmacopeial standards such as USP, EP, and CP. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support customer audits and provide full traceability and regulatory documentation (e.g., DMF) to facilitate your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, well-ventilated area at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Specific Rotation	+115° to +130° (c=1 in water)
Microbial Limits	Conforms to EP/USP

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