Description

Cefazedone Related Impurity 4 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 Cefazedone by enabling accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical quality control laboratories, analytical research and development teams, and manufacturers of active pharmaceutical ingredients (APIs) who require reliable impurity standards for method validation and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Cefazedone impurities in quality control (QC) testing.
• Analytical Method Development and Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Cefazedone drug substance and finished product stability testing.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., ANDA, DMF) by providing data on impurity characterization and control strategies.
• Process Chemistry Research: Aids in the investigation and optimization of Cefazedone synthesis pathways to minimize impurity formation.
• Pharmacopoeial Testing: Used to ensure compliance with pharmacopoeial monographs (e.g., USP, EP, BP) that specify impurity limits for Cefazedone.

Basic Information

Product Name	Cefazedone Related Impurity 4
CAS No.	70149-63-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefazedone Impurity 4; Cefazedone Impurity C; Cefazedone EP Impurity C; Cefazedone Related Compound C; (6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; 7-(D-α-Phenylglycylamido)-3-[(5-methyl-1,3,4-thiadiazol-2-ylthio)methyl]ceph-3-em-4-carboxylic acid
EINECS	Contact for details

Quality Control

Our Cefazedone Related Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for use as a reference material. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results for purity, identity, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

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)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0% w/w

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