Description

Ceftazidime Ep Impurity D CAS NO 73547-69-0 is a specified impurity and reference standard used in the quality control of the antibiotic Ceftazidime. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Ceftazidime formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Impurity D in Ceftazidime API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods used in quality control laboratories.
• Regulatory Compliance & Documentation: Used to generate data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity profiling and control in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Ceftazidime during forced degradation and long-term stability testing.
• Pharmaceutical Research (R&D): Utilized in research settings to study the degradation pathways, pharmacokinetics, and metabolic profile of Ceftazidime.
• Quality Control (QC) Testing: Routinely used in in-process control and release testing of Ceftazidime batches to ensure impurity levels remain within specified pharmacopeial limits (e.g., EP, USP).

Basic Information

Product Name	Ceftazidime Ep Impurity D
CAS No.	73547-69-0
Molecular Formula	C22H22N6O7S2
Molecular Weight	546.58 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Aminothiazol-4-yl)-2-(1-carboxy-1-methylethoxy)iminoacetyl]amino]-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Ceftazidime Impurity D; Ceftazidime Related Compound D; (Z)-Ceftazidime; Ceftazidime Pyridinium Isomer; 73547-69-0; Contact for details on additional synonyms.
EINECS	Contact for details

Quality Control

Our Ceftazidime Ep Impurity D is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR), to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support compliance with EP (European Pharmacopoeia), USP (United States Pharmacopeia), and ICH guidelines.

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 under dry conditions to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.