Description

Tazobactam Acid Impurity 17 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the β-lactamase inhibitor Tazobactam and its pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in antibiotic production.

Application

• Pharmaceutical Impurity Profiling and Identification in Tazobactam Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS assays to quantify related substances.
• Stability Studies and Forced Degradation Studies to monitor the formation of this specific impurity under various stress conditions.
• Quality Control and Release Testing of Tazobactam batches to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Regulatory Documentation and Submission, providing essential data for drug master files (DMFs) and regulatory filings.
• Research and Development into the degradation pathways and chemistry of Tazobactam and related β-lactamase inhibitors.
• Calibration Standard for ensuring the accuracy and precision of analytical instrumentation used in impurity analysis.

Basic Information

Product Name	Tazobactam Acid Impurity 17
CAS No.	117030-11-2
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; Tazobactam Impurity 17; Tazobactam Acid Impurity; Tazobactam Degradant; Zosyn Impurity; YTR-830H Impurity; Penicillanic acid sulfone derivative
EINECS	Contact for details

Quality Control

Our Tazobactam Acid Impurity 17 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided and are available upon request.

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 should be handled in a dry environment 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 corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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