Description

Cefotiam Impurity 1 is a specified impurity of the second-generation cephalosporin antibiotic, Cefotiam. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is primarily used by quality control laboratories and regulatory affairs departments within the pharmaceutical industry to ensure the purity, safety, and efficacy of Cefotiam active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefotiam Impurity 1 in drug substances and products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submission Support: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Aids in studying the degradation pathways and chemical behavior of Cefotiam during synthesis and formulation.

Basic Information

Product Name	Cefotiam Impurity 1
CAS No.	2243596-87-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefotiam Related Compound A; Cefotiam EP Impurity A; Cefotiam USP Impurity; Cefotiam Degradation Product; Cefotiam Process 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
EINECS	Contact for details

Quality Control

Our Cefotiam Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and determination of residual solvents. A Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to ensure full traceability and compliance with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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