Description

Tazobactam Impurity 2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the β-lactamase inhibitor Tazobactam. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Tazobactam Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities during the drug manufacturing process.
• Quality Assurance & Control (QA/QC): Employed in routine batch testing to ensure Tazobactam products meet the purity specifications outlined in pharmacopeias (USP, EP, JP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profiles and stability data to agencies like the FDA and EMA.
• Stability Studies: Used to track the formation of degradation products in Tazobactam under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process optimization for Tazobactam production.

Basic Information

Product Name	Tazobactam Impurity 2
CAS No.	1628710-72-4
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 EP Impurity B; Tazobactam USP Impurity; Tazobactam Degradant; TAZ Impurity 2; 1,2,3-Triazol-1-ylmethyl Tazobactam Derivative
EINECS	Contact for details

Quality Control

Every batch of Tazobactam Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and research needs.

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) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.