Description

Ceftazidime Ep Impurity H is a high-purity reference standard used for analytical and quality control purposes in the pharmaceutical industry. This compound is critical for ensuring the safety and efficacy of the antibiotic Ceftazidime by enabling the accurate identification and quantification of process-related impurities. It is an essential material for research and development laboratories, quality assurance units, and regulatory bodies involved in the production and validation of pharmaceutical products.

Application

• Primary use as a certified reference standard for the analysis of Ceftazidime.
• Method development and validation for impurity profiling in accordance with ICH guidelines.
• Quality control testing in the manufacturing of active pharmaceutical ingredients (APIs).
• Stability studies to monitor impurity levels in drug substances and finished products.
• Pharmacopoeial testing to comply with EP (European Pharmacopoeia), USP (United States Pharmacopeia), and other international standards.
• Calibration of analytical equipment such as HPLC and LC-MS systems.
• Research into the degradation pathways and impurity formation of cephalosporin antibiotics.

Basic Information

Product Name	Ceftazidime Ep Impurity H
CAS No.	1354396-23-8
Molecular Formula	C22H22N6O7S2
Molecular Weight	546.58 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Aminothiazol-4-yl)-2-(2-carboxypropan-2-yloxyimino)acetyl]amino]-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Ceftazidime Impurity H; Ceftazidime Related Compound H; Ceftazidime Pyridinium Impurity; EP Impurity H of Ceftazidime
EINECS	Contact for details

Quality Control

Every batch of Ceftazidime Ep Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure compliance with pharmacopoeial standards such as EP and USP. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment and is available upon request.

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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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