Description

Cefathiamidine 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 active pharmaceutical ingredient (API) Cefathiamidine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of the antibiotic Cefathiamidine.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed in forced degradation and long-term stability studies of Cefathiamidine to monitor impurity profiles over time.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing a characterized impurity for specification setting and safety assessment.
• Research & Development: Used in R&D to study the degradation pathways, synthesis impurities, and metabolic profiles of Cefathiamidine.
• Pharmacopoeial Testing: Serves as a system suitability standard for pharmacopoeial monographs (e.g., ChP, USP) related to Cefathiamidine.

Basic Information

Product Name	Cefathiamidine Impurity 4
CAS No.	1418224-75-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefathiamidine Related Compound 4; Cefathiamidine EP Impurity 4; Cefathiamidine USP Impurity 4; Cefathiamidine Degradation Product; Cefathiamidine Process Impurity; (6R,7R)-7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]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 impurity
EINECS	Contact for details

Quality Control

Every batch of Cefathiamidine Impurity 4 is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. Our products are supplied with a detailed Certificate of Analysis (COA) that includes data from multiple orthogonal techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. We support compliance with ICH Q3A/B guidelines and pharmacopoeial standards for impurity qualification.

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 should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.