Description

Valproic Acid Impurity (244Da) is a high-purity reference standard used for the identification, qualification, and quantification of related substances in Valproic Acid and its pharmaceutical formulations. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by monitoring and controlling impurity profiles. It is an essential material for pharmaceutical R&D, quality control laboratories, and manufacturers requiring rigorous analytical method development and validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the analytical testing of Valproic Acid API and finished drug products.
• Impurity Profiling and Identification: Used in HPLC, UPLC, and GC methods to identify and quantify this specific impurity during stability studies and release testing.
• Method Development and Validation: Critical for developing and validating chromatographic analytical methods in compliance with ICH Q2(R1) and USP guidelines.
• Quality Control & Assurance: Employed in routine QC testing to ensure Valproic Acid batches meet stringent pharmacopeial specifications (e.g., USP, EP, JP) for impurity limits.
• Stability Studies: Used to track the formation and growth of this impurity under various stress conditions (thermal, hydrolytic, photolytic) as per ICH Q1A(R2).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to health authorities like the FDA and EMA.

Basic Information

Item	Detail
Product Name	Valproic Acid Impurity (244Da)
CAS No.	62391-98-4
Molecular Formula	C8H16O2
Molecular Weight	144.21 g/mol
Synonyms	2-Propylpentanoic Acid Impurity; Valproate Impurity; Valproic Acid Related Compound; 244Da Impurity; 2-Propylvaleric Acid Impurity; Depakene Impurity; Divalproex Sodium Impurity; (C8) Valproic Acid Analog
EINECS	Contact for details

Quality Control

Every batch of Valproic Acid Impurity (244Da) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. Quality processes are designed to support regulatory requirements for pharmaceutical impurities.

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
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 individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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