Description

Valproic Acid Impurity 14 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in Valproic Acid and its derivative drug substances. It is primarily used by analytical laboratories and quality control units within the pharmaceutical industry to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for method development and validation in impurity profiling.
• Analytical Method Development: Used to establish and calibrate HPLC, UPLC, or GC methods for the detection of specific impurities.
• Quality Control & Assurance: Critical for routine batch testing of Valproic Acid active pharmaceutical ingredients (APIs) to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as a marker to track impurity formation in drug substance and product stability testing programs.
• Research & Development: Used in synthetic chemistry research to understand and mitigate impurity formation during the manufacturing process.

Basic Information

Product Name	Valproic Acid Impurity 14
CAS No.	258264-00-5
Molecular Formula	C8H16O2
Molecular Weight	144.21 g/mol
Synonyms	2-Propylpentanoic Acid Impurity 14; Valproate Impurity 14; 2-Propylglutaric Acid; 2-Propylpentanedioic Acid; 1,5-Pentanedioic acid, 2-propyl-; NSC 758439; UNII-8KQ660K66O
EINECS	Contact for details

Quality Control

Every batch of Valproic Acid Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. 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 inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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