Description

Lincomycin Ep Impurity B is a specified impurity and degradation product of the lincosamide antibiotic, Lincomycin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Lincomycin-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lincomycin Hydrochloride and related drug substances.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods in compliance with ICH Q2(R1) and pharmacopoeial guidelines.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity profiles and ensure drug product specifications meet stringent pharmacopoeial standards (USP, EP, BP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of ICH stability-indicating methods.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Common Technical Documents (CTD), and regulatory filings to agencies like the FDA and EMA.
• Research & Development: Supports studies on the degradation pathways, pharmacokinetics, and metabolic profiling of Lincomycin.

Basic Information

Product Name	Lincomycin Ep Impurity B
CAS No.	37744-65-3
Molecular Formula	C18H34N2O6S
Molecular Weight	406.54 g/mol
Synonyms	Lincomycin B; Lincomycin Impurity B; (2S,4R)-N-[(1S,2S,3R,4R,6R)-2,3,4-Trihydroxy-6-methylsulfanylcyclohexyl]-1-methyl-4-propylpyrrolidine-2-carboxamide; Lincomycin Related Compound B; Lincomycin EP Impurity B; Lincomycin USP Impurity B; Lincomycin Degradant B
EINECS	Contact for details

Quality Control

Our Lincomycin Ep Impurity B is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analysis. The material is suitable for use as a reference standard in compliance with ICH, USP, and European Pharmacopoeia (EP) guidelines.

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 compound is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere when appropriate to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.