Description

Tazobactam Impurity B is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the β-lactamase inhibitor Tazobactam, a key component in combination antibiotic therapies. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing. The precise characterization of this impurity is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Tazobactam active pharmaceutical ingredient (API) and finished drug products.
• Method Development & Validation: Used in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Tazobactam.
• Quality Control & Batch Release: Employed as a system suitability and identification marker in the routine QC testing of Tazobactam to monitor impurity profiles against ICH Q3A/B limits.
• Stability Studies: A critical marker for forced degradation and long-term stability studies to understand the degradation pathways of Tazobactam.
• Regulatory Compliance & Filings: Essential for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate control over the impurity profile.
• Research & Development: Used in synthetic chemistry R&D to study the formation and mitigation of this specific impurity during the manufacturing process.

Basic Information

Product Name	Tazobactam Impurity B
CAS No.	158411-82-6
Molecular Formula	C10H11N4O5S
Molecular Weight	299.28 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; TAZ 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 S,S-dioxide
EINECS	Contact for details

Quality Control

Every batch of Tazobactam Impurity B is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic techniques (HPLC, LC-MS) to ensure it meets the exacting standards required for pharmaceutical reference materials. 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) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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