Description

Cefathiamidine Impurity 16 CAS NO 744191-99-9 is a characterized impurity of the antibiotic Cefathiamidine, used as a critical reference standard in pharmaceutical development and quality control. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, testing, and approval of Cefathiamidine-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of Cefathiamidine Impurity 16 in API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Critical for routine quality control testing to ensure API batches meet stringent pharmacopeial (e.g., ChP, USP) or internal purity specifications.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to satisfy regulatory requirements (FDA, EMA, NMPA).
• Process Chemistry Research: Used by R&D scientists to study and optimize the Cefathiamidine synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Cefathiamidine Impurity 16
CAS No.	744191-99-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(5aR,6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-[(1-carboxy-1-methylethyl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefathiamidine Related Compound 16; Cefathiamidine EP Impurity; Cefathiamidine USP Impurity; Cefathiamidine Degradant; Cefathiamidine Process Impurity; Cefathiamidine Analog
EINECS	Contact for details

Quality Control

Our Cefathiamidine Impurity 16 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR/MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.