Description

Piperacillin Impurity 8/Piperacillin Dimer Impurity 3 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of the β-lactam antibiotic piperacillin by enabling the accurate identification and quantification of a specific dimeric impurity. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in research, development, and quality assurance of piperacillin-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in piperacillin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to establish specification limits and ensure batch-to-batch consistency and purity of piperacillin.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval processes.
• Research on Degradation Pathways: Serves as a key marker in research studies investigating the chemical stability and degradation mechanisms of piperacillin.

Basic Information

Product Name	Piperacillin Impurity 8 / Piperacillin Dimer Impurity 3
CAS No.	2170771-53-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Piperacillin Dimer; Piperacillin Related Compound; (2S,5R,6R)-6-[[(2R)-2-[[(4-ethyl-2,3-dioxopiperazin-1-yl)carbonyl]amino]-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid dimer; Piperacillin Impurity D; Antibiotic impurity; β-lactam impurity; Piperacillin degradation product
EINECS	Contact for details

Quality Control

Our Piperacillin Impurity 8 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The container should be kept in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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