Description

Cefalotin Impurity 6 is a specified impurity of the first-generation cephalosporin antibiotic, Cefalotin (Cephalothin). This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and analytical method validation. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of Cefalotin drug substances and products. Maintaining a reliable supply of this well-characterized impurity is essential for regulatory compliance and robust quality management systems.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefalotin Impurity 6 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities in Cefalotin.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various environmental conditions.
• Quality Control (QC) Testing: A critical component in routine QC laboratories for batch release testing of Cefalotin to ensure compliance with pharmacopoeial specifications (e.g., USP, EP).
• Regulatory Submissions: Provides necessary data on impurity profiles for regulatory filings (e.g., with FDA, EMA) to support drug approval processes.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways of Cefalotin, helping to improve formulation and storage strategies.

Basic Information

Item	Details
Product Name	Cefalotin Impurity 6
CAS No.	3432-90-4
Molecular Formula	C16H16N2O6S2
Molecular Weight	396.44 g/mol
Synonyms	(6R,7R)-3-[(Acetyloxy)methyl]-8-oxo-7-[(2-thienylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; 3-(Acetoxymethyl)-7-(2-thiopheneacetamido)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cephalothin Impurity 6; Cephalothin Related Compound F; Cefalotin Related Compound F
EINECS	Contact for details

Quality Control

Every batch of Cefalotin Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity (by HPLC), identification (by IR and/or MS), and other relevant physicochemical parameters.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.