Description

Cefotiam Impurity 22 is a designated chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antibiotic Cefotiam by serving as a known benchmark in chromatographic analysis. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of the active pharmaceutical ingredient (API) Cefotiam.
• Analytical Method Development: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity detection.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require complete impurity characterization and identification.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity in Cefotiam formulations under various storage conditions over time.
• Research & Development: Used in synthetic chemistry and process research to understand and minimize the formation of this impurity during Cefotiam manufacturing.
• Pharmacopeial Testing: Applied as a system suitability and identification standard in testing protocols aligned with USP, EP, or other pharmacopeias.

Basic Information

Product Name	Cefotiam Impurity 22
CAS No.	1628441-07-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefotiam Related Compound 22; Cefotiam EP Impurity 22; Cefotiam USP Impurity 22; 1-[[(6R,7R)-7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-5,6,7,8-tetrahydroquinolinium inner salt; Cefotiam Impurity C; Cefotiam Process Impurity
EINECS	Contact for details

Quality Control

Our Cefotiam Impurity 22 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods (NMR, MS) for structural verification, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability, consistency, and reliability for your critical applications.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

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)	Single unspecified impurity ≤ 2.0% 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.