Description

Ceftizoxime Impurity 19 is a designated chemical reference standard used in the analytical profiling and quality control of the antibiotic Ceftizoxime. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the final drug product by identifying and quantifying process-related impurities. It is essential for professionals engaged in method development, stability studies, and regulatory compliance within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Ceftizoxime sodium active pharmaceutical ingredient (API) and finished formulations.
• Analytical Method Development & Validation: Used to develop, calibrate, and validate High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Ceftizoxime under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Serves as a key reagent in pharmaceutical R&D for studying the synthesis pathway, degradation mechanisms, and metabolism of Ceftizoxime.
• Contract Research & Testing Laboratories: Utilized by third-party labs offering analytical testing services to the pharmaceutical industry for batch release testing.

Basic Information

Product Name	Ceftizoxime Impurity 19
CAS No.	64918-77-0
Molecular Formula	C13H13N5O5S2
Molecular Weight	383.41 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-8-oxo-3-[(1,2,3-thiadiazol-5-ylsulfanyl)methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Ceftizoxime Related Compound 19; Ceftizoxime EP Impurity 19; Ceftizoxime USP Impurity 19; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-methoxyiminoacetamido]-3-(1,2,3-thiadiazol-5-ylthiomethyl)-3-cephem-4-carboxylic Acid
EINECS	Contact for details

Quality Control

Every batch of Ceftizoxime Impurity 19 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using validated methods such as HPLC, NMR, and mass spectrometry 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 each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

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%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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