Description

Piperacillin Impurity CAS NO 2170771-47-6 is a high-purity chemical reference standard used for the identification, qualification, and quantification of process-related impurities in the active pharmaceutical ingredient (API) piperacillin. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of piperacillin-based pharmaceutical formulations. It is an essential material for quality control laboratories in pharmaceutical manufacturing, contract research organizations (CROs), and regulatory bodies focused on antibiotic development and analysis.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation in QC/QA.
• Impurity Profiling: Identification and quantification of specific impurities during the stability testing and release of Piperacillin API and its drug products.
• Regulatory Compliance & Filings: Supporting regulatory submissions (e.g., ANDA, NDA) to agencies like the US FDA and EMA by providing impurity characterization data.
• Research & Development: Used in process chemistry research to understand and control impurity formation during the synthesis of Piperacillin.
• Pharmacopoeial Testing: Employed as a system suitability standard in tests prescribed by USP, EP, or other pharmacopoeias for Piperacillin.

Basic Information

Product Name	Piperacillin Impurity
CAS No.	2170771-47-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Piperacillin Related Compound; Piperacillin Process Impurity; (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 impurity; Piperacillin EP Impurity; Piperacillin USP Impurity; Antibiotic Impurity Standard; β-Lactam Impurity
EINECS	Contact for details

Quality Control

Every batch of Piperacillin Impurity (CAS 2170771-47-6) is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity confirmation, purity analysis, and stability testing to ensure they meet the exacting standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results from advanced analytical techniques (HPLC, LC-MS, NMR) is provided with each shipment to support your regulatory and quality assurance needs.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

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

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