Description

Lincomycin Ep Impurity F is a specified impurity and reference standard used in the quality control of the antibiotic Lincomycin. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical products by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with pharmacopeial monographs.

Application

• Primary use as a certified reference standard (CRS) for pharmacopeial testing (EP, USP).
• Critical component in analytical method development and validation for Lincomycin and its formulations.
• Used in stability-indicating assays to monitor degradation in pharmaceutical products.
• Essential for impurity profiling and identification to meet ICH Q3A/B guidelines.
• Supports quality control (QC) and quality assurance (QA) processes in GMP manufacturing.
• Utilized in regulatory submissions to demonstrate product quality and compliance.
• Research tool in pharmacokinetic and metabolic studies of Lincomycin.

Basic Information

Product Name	Lincomycin Ep Impurity F
CAS No.	14810-93-6
Molecular Formula	C18H34N2O6S
Molecular Weight	406.54 g/mol
Synonyms	Lincomycin B; Lincomycin Sulfoxide; (2S,4R)-N-[(1S,2S,3R,4R,6S)-4,6-Dimethyl-1-[(2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(methylsulfinyl)oxan-2-yl]oxy-2,3-dihydroxycyclohexyl]-1-methyl-4-propylpyrrolidine-2-carboxamide; Lincomycin Related Compound F; Lincomycin EP Impurity F; Lincomycin Sulfoxide Impurity; Lincomycin Metabolite; Lincomycin Oxidation Product
EINECS	Contact for details

Quality Control

Our Lincomycin Ep Impurity F is manufactured and tested under strict quality systems to meet the exacting standards of the pharmaceutical industry. Each batch is characterized and qualified against pharmacopeial reference standards where applicable. We provide comprehensive analytical data, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis. A detailed Certificate of Analysis (COA) is supplied with every shipment, ensuring full traceability and compliance with GMP and ISO guidelines for reference materials.

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 COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% 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.