Description

Tazobactam Impurity CAS NO 331413-40-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the β-lactamase inhibitor Tazobactam, a key component in combination antibiotics. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of well-characterized impurities is essential for maintaining strict compliance with Good Manufacturing Practice (GMP) and pharmacopeial standards.

Application

• Pharmaceutical Quality Control (QC): Serves as a certified reference standard for the identification and quantification of impurities in Tazobactam Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of degradation products in Tazobactam under various stress conditions (e.g., heat, light, humidity).
• Research & Development (R&D): Used in synthetic chemistry research to study the degradation pathways and metabolism of Tazobactam.
• Pharmacopeial Testing: Supports testing as per United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), or other international pharmacopeia monographs for Tazobactam.

Basic Information

Product Name	Tazobactam Impurity
CAS No.	331413-40-2
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 Related Compound; Tazobactam Degradant; Tazobactam Process Impurity; Penicillanic acid sulfone derivative; TAZ impurity; SR 2-[(2S,3S,5R)-3-Methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]hept-2-yl]-2-hydroxyacetic acid 4,4-dioxide
EINECS	Contact for details

Quality Control

Every batch of Tazobactam Impurity (CAS 331413-40-2) is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, NMR, and Mass Spectrometry to ensure compliance with pharmaceutical reference standard requirements. 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 controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% 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.