Description

Cefixime Impurity 18/(Z)-2-Hydroxyimino-3-Oxo-Butyric Acid tert-Butyl Ester is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity standard for the quality control and validation of the third-generation cephalosporin antibiotic, Cefixime. It is essential for analytical laboratories, quality assurance departments, and R&D teams in the pharmaceutical industry to ensure drug safety, efficacy, and regulatory compliance. The precise characterization of such impurities is fundamental to meeting stringent pharmacopeial standards for active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefixime Impurity 18 in drug substance and finished product analysis.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity profiling of Cefixime.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed as a marker to track degradation pathways and establish the shelf-life of Cefixime formulations under various storage conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to health authorities like the FDA and EMA.
• Process Chemistry Research: Used to study and optimize synthetic pathways for Cefixime, helping to minimize the formation of this specific impurity during manufacturing.

Basic Information

Product Name	Cefixime Impurity 18/(Z)-2-Hydroxyimino-3-Oxo-Butyric Acid tert-Butyl Ester
CAS No.	79232-64-7
Molecular Formula	C8H13NO4
Molecular Weight	187.19 g/mol
Synonyms	(Z)-2-(Hydroxyimino)-3-oxobutanoic acid tert-butyl ester; tert-Butyl (Z)-2-(hydroxyimino)-3-oxobutanoate; 2-(Hydroxyimino)-3-oxo-butyric acid tert-butyl ester; Cefixime Related Compound H (EP); Cefixime Impurity H; Cefixime Impurity 18 (USP); (Z)-Isomer of O-tert-Butyl 2-hydroxyiminoacetoacetate; Butanoic acid, 2-(hydroxyimino)-3-oxo-, 1,1-dimethylethyl ester, (2Z)-
EINECS	Contact for details

Quality Control

Our Cefixime Impurity 18 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, GC, NMR, and MS to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, related substances, and residual solvents. Our quality standards are designed to support compliance with ICH guidelines and global pharmacopeial requirements (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere if prolonged storage or after opening is required.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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