Description

Tazobactam Acid Impurity 16 is a high-purity chemical reference standard, specifically identified as a known impurity of the β-lactamase inhibitor Tazobactam. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the purity and safety of the final drug product. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) involved in the production and analysis of Tazobactam and its combination drugs.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Tazobactam Acid Impurity 16 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling of Tazobactam.
• Quality Control & Stability Studies: Essential for routine QC testing and forced degradation studies to monitor impurity levels and ensure product stability and shelf-life.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research on Degradation Pathways: Utilized in research to understand the formation pathways and chemical behavior of this specific impurity under various conditions.

Basic Information

Product Name	Tazobactam Acid Impurity 16
CAS No.	89051-57-0
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 16; Tazobactam Related Compound 16; TAZ Impurity 16; Penicillanic acid sulfone derivative
EINECS	Contact for details

Quality Control

Our Tazobactam Acid Impurity 16 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with every shipment.

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 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 reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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