Description

Cefotiam Impurity 10 is a specified impurity and reference standard used in the analytical profiling of the antibiotic Cefotiam. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of Cefotiam in compliance with ICH guidelines.
• Method Development and Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify this specific impurity.
• Quality Control and Batch Release: Employed in the routine testing of Cefotiam API and finished drug products to ensure impurity levels remain within specified limits.
• Stability Studies: Used to monitor the formation of Cefotiam Impurity 10 over time under various stress conditions (e.g., heat, humidity, light) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Aids in understanding the degradation pathways and chemical behavior of Cefotiam during synthesis and formulation processes.

Basic Information

Item	Detail
Product Name	Cefotiam Impurity 10
CAS No.	108118-38-3
Molecular Formula	C18H23N9O4S3
Molecular Weight	525.63 g/mol
Synonyms	(6R,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 Degradant; Cefotiam Metabolite; Antibiotic Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Cefotiam Impurity 10 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced chromatographic techniques (HPLC, LC-MS) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to ensure stability.

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%
Assay (HPLC)	90.0% - 110.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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