Description

Valproic Acid Impurity 15 is a high-purity chemical reference standard used in pharmaceutical development and quality control. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities in Valproic Acid and its derivative drug products. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry, ensuring drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for method development, validation, and routine quality control testing of Valproic Acid API and finished dosage forms.
• Impurity Profiling: Used in HPLC, UPLC, and GC analytical methods to establish impurity profiles, identify unknown peaks, and confirm the presence of this specific impurity.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in Valproic Acid drug substances and products under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Method Transfer & Verification: Serves as a system suitability standard to ensure analytical methods perform consistently across different laboratories and instruments.
• Research & Development: Used in synthetic chemistry research to study the formation mechanism of this impurity and develop mitigation strategies during API manufacturing.

Basic Information

Product Name	Valproic Acid Impurity 15
CAS No.	2985-35-5
Molecular Formula	C8H16O2
Molecular Weight	144.21 g/mol
Synonyms	2-Propylpentanoic Acid Impurity 15; Valproate Impurity 15; 2-Propylvaleric Acid Related Compound; Depakene Impurity 15; 2-Propylpentanoic Acid Analog; Valproic Acid Related Substance 15; 4-Methyl-2-propylpentanoic Acid (Check Isomer); Heptanoic acid, 4-methyl-2-propyl-
EINECS	Contact for details

Quality Control

Every batch of Valproic Acid Impurity 15 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure compliance with ICH Q3A, Q3B, and USP guidelines for impurities. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under an inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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