Description

Cefazolin Impurity 15/n-(2,2-Dimethoxyethyl)-2-(1H-Tetrazol-1-Yl)Acetamide is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity in the analysis and validation of the antibiotic Cefazolin, ensuring the safety and efficacy of the final drug product. It is an essential material for analytical laboratories, regulatory compliance, and pharmaceutical development teams focused on impurity profiling and method development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Cefazolin Impurity 15 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in compliance with ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure Cefazolin drug substance and drug product meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of ICH stability protocols.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing robust purification processes.

Basic Information

Item	Details
Product Name	Cefazolin Impurity 15/n-(2,2-Dimethoxyethyl)-2-(1H-Tetrazol-1-Yl)Acetamide
CAS No.	1809086-26-7
Molecular Formula	C9H15N5O3
Molecular Weight	241.25 g/mol
Synonyms	Cefazolin Impurity 15; N-(2,2-Dimethoxyethyl)-2-(1H-tetrazol-1-yl)acetamide; 2-(1H-Tetrazol-1-yl)-N-(2,2-dimethoxyethyl)acetamide; Cefazolin Related Compound 15; Cefazolin EP Impurity I; Cefazolin USP Impurity; Acetamide, N-(2,2-dimethoxyethyl)-2-(1H-tetrazol-1-yl)-
EINECS	Contact for details

Quality Control

Every batch of Cefazolin Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial and internal specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture, which may affect stability and purity.

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 single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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