Description

Piperacillin Impurity 12 Disodium Salt is a high-purity chemical reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity for the antibiotic Piperacillin, enabling precise identification, quantification, and monitoring during drug development and manufacturing. It is an essential material for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology sectors who require reliable standards to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and quantification of impurities in Piperacillin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies and Forced Degradation Testing: Employed to understand the degradation pathways of Piperacillin and to establish stability-indicating methods.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity information and control strategies.
• Pharmacopoeial Testing: Used in testing to meet the specifications of various pharmacopoeias (e.g., USP, EP, JP) for Piperacillin and related preparations.
• Research and Development: Utilized in academic and industrial R&D for studying the chemistry, metabolism, and safety profile of β-lactam antibiotics.

Basic Information

Product Name	Piperacillin Impurity 12 Disodium Salt
CAS No.	64844-70-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S,5R,6R)-3,3-Dimethyl-7-oxo-6-[(2R)-2-[(4-ethyl-2,3-dioxopiperazine-1-carbonyl)amino]-2-phenylacetamido]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid disodium salt; Piperacillin Related Compound 12 Disodium Salt; Disodium (2S,5R,6R)-6-[[(2R)-2-[[(4-ethyl-2,3-dioxo-1-piperazinyl)carbonyl]amino]-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate; Piperacillin EP Impurity 12 Disodium; Piperacillin USP Impurity 12 Disodium
EINECS	Contact for details

Quality Control

Every batch of Piperacillin Impurity 12 Disodium Salt is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR 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 and confirming compliance with our stringent specifications.

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 in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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