Description

Valproic Acid Related Compound B (50 Mg) ((2Rs)-2-(1-Methylethyl)Pentanoic Acid) (As) is a high-purity analytical reference standard, specifically a chiral impurity of the active pharmaceutical ingredient Valproic Acid. This compound is critical for ensuring the quality, safety, and efficacy of Valproic Acid and its formulations through precise analytical testing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) for method development, validation, and routine impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific chiral impurities in Valproic Acid drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, GC) for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure batches meet stringent purity specifications and regulatory standards.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Valproic Acid formulations under various stress conditions.
• Pharmacopoeial Compliance: Supports testing to meet the requirements of pharmacopoeias such as USP, EP, and BP for Valproic Acid and related drug products.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Valproic Acid Related Compound B (50 Mg) ((2Rs)-2-(1-Methylethyl)Pentanoic Acid) (As)
CAS No.	62391-99-5
Molecular Formula	C8H16O2
Molecular Weight	144.21 g/mol
Synonyms	(2R)-2-Isopropylpentanoic Acid; (R)-2-Isopropylvaleric Acid; (2R)-2-(1-Methylethyl)pentanoic Acid; (R)-2-(1-Methylethyl)pentanoic Acid; (R)-2-Isopropylpentanoic Acid; Valproic Acid Impurity B; Valproic Acid Related Substance B; (2R)-2-Isopropylvaleric Acid
EINECS	Contact for details

Quality Control

This analytical standard is manufactured under strict quality management systems. Each batch is subjected to comprehensive testing, including chiral purity verification, identity confirmation (IR, NMR), and quantitative assay (HPLC), to ensure it meets the exacting standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each unit, containing batch-specific data. Our quality systems support compliance with cGMP and relevant ICH guidelines.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is kept sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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