Description

Lincomycin Ep Impurity C is a specified impurity of the antibiotic Lincomycin, identified by the CAS number 14600-41-0. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials for ensuring the purity, safety, and efficacy of Lincomycin-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Lincomycin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with pharmacopoeial specifications (e.g., EP, USP).
• Stability Studies: Employed to track the formation of degradation products in Lincomycin formulations under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Serves as a key material in pharmaceutical R&D for studying the degradation pathways and stability of Lincomycin.

Basic Information

Product Name	Lincomycin Ep Impurity C
CAS No.	14600-41-0
Molecular Formula	C18H34N2O6S
Molecular Weight	406.54 g/mol
Synonyms	Lincomycin B; Lincomycin B Hydrochloride (base); (2S,4R)-N-[(1S,2S,3R,4R,6S)-4,6-Dimethyl-1-[(2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxy-2,3-dihydroxycyclohexyl]-1-methyl-4-propylpyrrolidine-2-carboxamide; Lincomycin Impurity C; Lincomycin Related Compound C; Lincomycin EP Impurity C; Antibiotic U-10149A
EINECS	Contact for details

Quality Control

Every batch of Lincomycin Ep Impurity C is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with current industry and pharmacopoeial expectations for reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, NMR, and MS.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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