Description

Tazobactam Impurity B is a high-purity chemical reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound is essential for ensuring the safety and efficacy of the β-lactamase inhibitor Tazobactam by accurately identifying and quantifying related substances. It is primarily used by pharmaceutical R&D laboratories, quality assurance departments, and regulatory testing facilities for impurity profiling, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Tazobactam Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity analysis.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to ensure Tazobactam API and formulations meet stringent pharmacopeial purity specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation impurities in Tazobactam under various stress conditions (e.g., heat, humidity, light) over time.
• Regulatory Compliance & Submission: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Tazobactam Impurity B
CAS No.	115546-66-2
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 B; Tazobactam EP Impurity B; Tazobactam USP Impurity B; 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 Acid Impurity; Zosyn Impurity B
EINECS	Contact for details

Quality Control

Our Tazobactam Impurity B 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 purity assay, related substances, residual solvents, and other relevant tests. The quality standard is aligned with the requirements for pharmaceutical impurity reference materials as per ICH Q3A, Q3B, USP, and EP guidelines.

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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment away from direct light exposure 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C limits

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