Description

Cefotiam Impurity CAS NO 58684-56-3 is a high-purity chemical reference standard essential for pharmaceutical research and quality control. This compound serves as a critical marker for identifying and quantifying process-related impurities in the synthesis of the antibiotic Cefotiam. It is primarily required by analytical laboratories and pharmaceutical manufacturers engaged in method development, stability studies, and regulatory compliance testing to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Cefotiam and related substances.
• Impurity Profiling: Critical for identifying, characterizing, and monitoring specified and unspecified impurities during Cefotiam API (Active Pharmaceutical Ingredient) development and manufacturing.
• Method Development & Validation: Employed in developing and validating analytical methods, particularly HPLC and UPLC, for impurity detection and separation.
• Quality Assurance/Quality Control (QA/QC): An essential tool for in-process control and final release testing of Cefotiam batches to meet pharmacopeial standards (e.g., USP, EP, JP).
• Stability Studies: Used to track the formation of degradation products in Cefotiam formulations under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity identification and specification limits.

Basic Information

Product Name	Cefotiam Impurity
CAS No.	58684-56-3
Molecular Formula	C18H23N9O4S3
Molecular Weight	525.63 g/mol
Synonyms	(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; Cefotiam Related Compound; Cefotiam Impurity A; 7β-[2-(2-Aminothiazol-4-yl)acetamido]-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
EINECS	Contact for details

Quality Control

Our Cefotiam Impurity is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR), purity assessment by HPLC, and determination of residual solvents. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with in-house specifications aligned with ICH guidelines.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. 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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Meets ICH Q3C guidelines

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