Description

Cefotiam Impurity 2 is a specified impurity of the broad-spectrum cephalosporin antibiotic, Cefotiam. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable standards for impurity profiling and regulatory compliance. Ensuring the identity and purity of this compound is fundamental to maintaining the safety and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefotiam Impurity 2 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure drug substance purity meets pharmacopeial specifications (e.g., USP, EP, JP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as per ICH Q1A(R2).
• Regulatory Submissions: Provides essential data for impurity identification and qualification reports required for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation during API synthesis.

Basic Information

Item	Details
Product Name	Cefotiam Impurity 2
CAS No.	1566599-01-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(7R)-7-[(2-Amino-4-thiazolyl)(methoxyimino)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 EP Impurity; Cefotiam USP Impurity; Cefotiam Hydrochloride Impurity; Cefotiam Degradation Product; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid derivative
EINECS	Contact for details

Quality Control

Every batch of Cefotiam Impurity 2 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, NMR, MS) to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 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 desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
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%
Residue on Ignition	≤ 0.5%

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