Description

Ceftezole Impurity 22 is a specified impurity of the antibiotic Ceftezole, identified by CAS NO 43194-95-2. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry for method validation, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Ceftezole.
• Impurity Profiling & Identification: Essential for identifying and quantifying this specific impurity during drug substance and drug product testing.
• Method Development & Validation: Serves as a critical component in developing and validating analytical methods, such as HPLC and LC-MS.
• Quality Control (QC) & Quality Assurance (QA): Enables monitoring and control of impurity levels to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Used to track the formation of this impurity over time under various storage conditions.

Basic Information

Product Name	Ceftezole Impurity 22
CAS No.	43194-95-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ceftezole Related Compound 22; Ceftezole EP Impurity 22; Ceftezole USP Impurity 22; (6R,7R)-3-[[(5-Methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[(2-thienylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid impurity; Ceftezole Specified Impurity; Ceftezole Degradant
EINECS	Contact for details

Quality Control

Our Ceftezole Impurity 22 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (IR, MS, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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