Description

Cefathiamidine Impurity 5 is a specified impurity of the antibiotic Cefathiamidine, identified by the CAS registry number 40818-86-8. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily needed by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the synthesis, purification, and validation of Cefathiamidine to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cefathiamidine active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Assurance & Control (QA/QC): Critical for routine batch testing to ensure Cefathiamidine meets pharmacopeial standards (e.g., EP, USP, ChP) for impurity limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stability-indicating conditions.
• Process Chemistry Research: Used by chemists to study and optimize the synthesis pathway of Cefathiamidine to minimize the formation of this impurity.

Basic Information

Product Name	Cefathiamidine Impurity 5
CAS No.	40818-86-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefathiamidine Related Compound 5; Cefathiamidine EP Impurity 5; Cefathiamidine USP Impurity 5; Cefathiamidine Impurity C; (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; Cefathiamidine Degradation Product; Cefaloram Impurity
EINECS	Contact for details

Quality Control

Our Cefathiamidine Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for use as a reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality requirements.

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 stability, consider storage at 2-8°C. Handle the material in accordance with good laboratory practices.

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)	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.