Description

Cefalotin Ep Impurity B CAS NO 5547-29-5 is a high-purity chemical reference standard, specifically identified as a key impurity and degradation product of the antibiotic Cephalothin. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of impurities in Cephalothin active pharmaceutical ingredients (APIs) and finished drug products. It is an essential material for analytical laboratories in the pharmaceutical industry, regulatory bodies, and contract research organizations (CROs) focused on ensuring drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Cephalothin.
• Impurity Profiling and Identification: Used in method development and validation to identify and quantify Cefalotin Ep Impurity B in API and formulation samples.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical manufacturing to ensure impurity levels are within specified limits.
• Regulatory Compliance and Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity standards for drug master files (DMFs).
• Research and Development: Aids in the study of degradation pathways and the synthesis of pure Cephalothin.

Basic Information

Product Name	Cefalotin Ep Impurity B
CAS No.	5547-29-5
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; Cephalothin Impurity B; Cephalothin EP Impurity B; Cefalotin Impurity B; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 3-[(acetyloxy)methyl]-8-oxo-7-[(2-thienylacetyl)amino]-, (6R,7R)-; Cephalothin Related Compound B
EINECS	Contact for details

Quality Control

Every batch of Cefalotin Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards (e.g., EP, USP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to guarantee traceability and support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.