Description

Cefotiam Impurity 13 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antibiotic Cefotiam by enabling precise identification and quantification of related substances. It is an essential material for pharmaceutical quality control laboratories, analytical research and development teams, and regulatory compliance units focused on cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Cefotiam active pharmaceutical ingredient (API) and finished drug products.
• Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in pharmaceutical R&D.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure batches comply with ICH Q3A/B guidelines and pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to identify and track degradation products formed during forced degradation and long-term stability studies of Cefotiam.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CEP) by characterizing impurity structures and levels.
• Academic & Contract Research: Serves as a research tool in universities and CROs for studying the chemistry, metabolism, and degradation pathways of cephalosporin antibiotics.

Basic Information

Product Name	Cefotiam Impurity 13
CAS No.	759418-62-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefotiam Related Compound 13; Cefotiam EP Impurity C; Cefotiam USP Impurity; (6R,7R)-7-[[(2-Amino-4-thiazolyl)acetyl]amino]-3-[[[1-(2-dimethylaminoethyl)-1H-tetrazol-5-yl]thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid impurity; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)acetyl]amino]-3-[[[1-(2-(dimethylamino)ethyl)-1H-tetrazol-5-yl]thio]methyl]-8-oxo-, (6R,7R)-; Cefotiam Impurity C (EP); Cefotiam Impurity
EINECS	Contact for details

Quality Control

Our Cefotiam Impurity 13 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Production can be aligned with current Good Manufacturing Practice (cGMP) principles for critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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. For long-term storage, consider conditions under an inert atmosphere.

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.