Description

Clindamycin Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antibiotic clindamycin by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and research institutions focused on method development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Clindamycin API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity profiles and stability data.
• Pharmacopeial Testing: Employed in testing to meet the stringent purity requirements of pharmacopeias such as USP, EP, and BP.
• Stability Studies: Used to monitor the formation of degradation products in Clindamycin under various storage conditions.
• Research & Development: Serves as a key intermediate or marker in synthetic pathway studies and impurity synthesis research.

Basic Information

Product Name	Clindamycin Impurity
CAS No.	198080-64-7
Molecular Formula	C18H33ClN2O5S
Molecular Weight	424.98 g/mol
Synonyms	Clindamycin Related Compound; Clindamycin EP Impurity; Clindamycin USP Impurity; (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; Lincomycin derivative
EINECS	Contact for details

Quality Control

Every batch of our Clindamycin Impurity (CAS 198080-64-7) is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including chromatographic purity, identity confirmation, and quantitative assay. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting compliance with specified standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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