Description

Tazobactam Acid Impurity 18 is a specified impurity of the β-lactamase inhibitor Tazobactam, identified by the CAS registry number 89051-47-8. This high-purity reference standard is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of related substances in Tazobactam drug substances and finished products. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, supporting compliance with stringent regulatory guidelines for impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Tazobactam and its related drug products.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) assays.
• Quality Control and Assurance: Used in routine QC testing to monitor and control impurity levels, ensuring Tazobactam API and formulations meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification reports required by agencies like the FDA and EMA.
• Research and Development: Supports synthetic route optimization and process chemistry by helping to understand and minimize impurity formation.

Basic Information

Product Name	Tazobactam Acid Impurity 18
CAS No.	89051-47-8
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 18; Tazobactam Related Compound 18; TAZ Imp-18; 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; YTR-830H Impurity 18
EINECS	Contact for details

Quality Control

Our Tazobactam Acid Impurity 18 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with batch-specific data, supporting its use as a reference standard in regulated environments. Our quality commitment ensures consistency and reliability for your critical pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure containers are sealed after use to prevent absorption of atmospheric moisture.

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)	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.