Description

Tazobactam Acid Impurity 12 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the β-lactamase inhibitor Tazobactam and its pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Tazobactam Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profiles and data for drug master files.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in Tazobactam under various stress conditions.
• Process Chemistry Research: Used by R&D chemists to study and optimize synthesis pathways, helping to minimize the formation of this specific impurity during manufacturing.
• Pharmacopeial Testing: Serves as a reference material for testing against specifications outlined in pharmacopeias such as USP, EP, or JP.

Basic Information

Product Name	Tazobactam Acid Impurity 12
CAS No.	120701-86-2
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 Impurity 12; Tazobactam Related Compound 12; TAZ Impurity 12; Tazobactam Acidic Impurity; 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
EINECS	Contact for details

Quality Control

Every batch of Tazobactam Acid Impurity 12 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and impurity profile testing using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.