Description

Cefotiam Impurity 6 CAS NO 1628441-02-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Cefotiam by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical quality control laboratories, analytical research and development teams, and regulatory affairs departments focused on cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control and release testing of Cefotiam active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating chromatographic methods (e.g., HPLC, UPLC) to accurately identify and quantify this specific impurity.
• Stability Studies & Degradation Profiling: Used to monitor the formation of this impurity during forced degradation and long-term stability studies of Cefotiam, supporting shelf-life determination.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification, characterization, and control strategies (ICH Q3A/B).
• Research on Degradation Pathways: Supports chemical research aimed at understanding the synthesis, degradation mechanisms, and metabolism of cephalosporin antibiotics.
• Calibration of Laboratory Equipment: Serves as a precise calibrant for spectroscopic and mass spectrometric systems in analytical laboratories.

Basic Information

Product Name	Cefotiam Impurity 6
CAS No.	1628441-02-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefotiam Related Compound 6; Cefotiam EP Impurity 6; Cefotiam USP Impurity 6; 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 6 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is rigorously tested using validated analytical methods, including HPLC for purity and identity confirmation via spectroscopic techniques. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (e.g., USP, EP) for impurity 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). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be sealed under inert atmosphere after each use to prevent degradation.

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)	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.