Description

Clindamycin Impurity 20 CAS NO 2090590-93-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of process-related impurities in Clindamycin drug substances and finished products. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing, ensuring product safety and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Clindamycin API and formulations.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to ensure impurity levels meet pharmacopeial (USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Used to monitor the formation of degradation products in Clindamycin under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Supports chemical research into the degradation pathways and synthesis of Clindamycin and related compounds.

Basic Information

Product Name	Clindamycin Impurity 20
CAS No.	2090590-93-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clindamycin Related Compound 20; Clindamycin EP Impurity 20; Clindamycin USP Impurity 20; Clindamycin Process Impurity; Clindamycin Degradant; (2S,4R)-N-[(1S,2S)-2-Chloro-1-[(2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide (IUPAC-based); Lincomycin derivative impurity
EINECS	Contact for details

Quality Control

Our Clindamycin Impurity 20 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, LC-MS, NMR, and IR spectroscopy. We adhere to relevant industry standards for reference materials to support your compliance with ICH Q3A, Q3B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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