Description

Cefotiam Impurity 1 CAS NO 775233-43-7 is a high-purity chemical reference standard specifically identified as a process-related impurity of the antibiotic Cefotiam. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by research institutions, quality assurance laboratories, and API producers involved in the synthesis and purification of Cefotiam to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefotiam Impurity 1 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during Cefotiam production.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine testing to ensure Cefotiam API meets pharmacopeial specifications (e.g., USP, EP, JP).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) for drug stability profiling.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used by chemists to study and optimize synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Cefotiam Impurity 1
CAS No.	775233-43-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(5R,6R)-3-[(Acetyloxy)methyl]-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-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 Process Impurity; Antibiotic Impurity; Cefotiam Derivative
EINECS	Contact for details

Quality Control

Our Cefotiam Impurity 1 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and trace analysis is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

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.