Description

Ceftazidime Impurity 12 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Ceftazidime by serving as a benchmark for impurity profiling and method validation. It is an essential material for pharmaceutical quality control laboratories, analytical research and development teams, and regulatory affairs departments focused on antibiotic manufacturing and testing.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Ceftazidime Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity detection in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control and Batch Release Testing: Employed in routine QC testing to monitor impurity levels and ensure Ceftazidime batches meet pharmacopoeial specifications (USP, EP, BP).
• Stability Studies and Forced Degradation: Acts as a marker in stability-indicating assays to track the formation of specific degradation products under various stress conditions.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies.
• Research on Degradation Pathways: Supports investigative studies into the chemical stability and degradation mechanisms of Ceftazidime.

Basic Information

Product Name	Ceftazidime Impurity 12
CAS No.	83654-89-1
Molecular Formula	C22H22N6O7S2
Molecular Weight	546.58 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-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 Pyridinium Impurity; Ceftazidime Related Compound J; Ceftazidime EP Impurity J; Ceftazidime USP Related Compound J; 7β-[2-(2-Aminothiazol-4-yl)-2-(1-carboxy-1-methylethoxyimino)acetamido]-3-(1-pyridiniomethyl)ceph-3-em-4-carboxylate
EINECS	Contact for details

Quality Control

Every batch of Ceftazidime Impurity 12 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for use as a reference standard. A detailed Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with cGMP and relevant pharmacopoeial guidelines.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. Desiccants are recommended for long-term storage.

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)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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