Description

Baclofen Impurity 4 CAS NO 159112-23-9 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 active pharmaceutical ingredient Baclofen. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling and Identification in Baclofen API and finished dosage forms.
• Analytical Method Development and Validation for HPLC, GC, and other chromatographic techniques.
• Quality Control and Assurance (QC/QA) as a certified reference material for in-house testing.
• Stability Studies to monitor and quantify degradation products in Baclofen formulations.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA and EMA.
• Research and Development (R&D) for studying the metabolism and degradation pathways of Baclofen.

Basic Information

Product Name	Baclofen Impurity 4
CAS No.	159112-23-9
Molecular Formula	C10H12ClNO2
Molecular Weight	213.66 g/mol
Synonyms	4-(4-Chlorophenyl)-2-pyrrolidinone; (RS)-4-(4-Chlorophenyl)pyrrolidin-2-one; Baclofen Related Compound D; Baclofen EP Impurity D; Baclofen USP Impurity D; 4-(p-Chlorophenyl)-2-pyrrolidinone; γ-Amino-β-(4-chlorophenyl)butyric acid lactam
EINECS	Contact for details

Quality Control

Our Baclofen Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH guidelines and pharmacopeial standards (USP, EP).

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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