Description

Tazobactam Impurity 5 is a high-purity reference standard used for the analytical profiling and quality control of the β-lactamase inhibitor, Tazobactam. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of Tazobactam-based drug formulations. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory compliance sectors for method development and validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Tazobactam Impurity 5 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing in GMP environments to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory dossiers for FDA, EMA, and other global health authorities by providing impurity characterization data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Tazobactam.

Basic Information

Product Name	Tazobactam Impurity 5
CAS No.	115546-67-3
Molecular Formula	C10H12N4O5S
Molecular Weight	300.29 g/mol
Synonyms	(2S,3S,5R)-3-Methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide; Tazobactam Impurity E; Tazobactam Related Compound E; Tazobactam EP Impurity E; Tazobactam USP Impurity E; Tazobactam Acid Impurity; 3-Methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide
EINECS	Contact for details

Quality Control

Our Tazobactam Impurity 5 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. The product is suitable for use as a reference standard in compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled under controlled humidity conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
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.