Description

Valproic Acid Impurity 7 is a specified impurity and reference standard used in the quality control of the active pharmaceutical ingredient (API) Valproic Acid and its related drug products. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations by enabling accurate identification and quantification of process-related impurities. It is an essential material for analytical laboratories, quality assurance departments, and research institutions engaged in pharmaceutical development, stability studies, and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Valproic Acid Impurity 7 in drug substance and finished product analysis.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, GC) for impurity profiling in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Serves as a system suitability and calibration standard in routine QC testing to ensure API and drug product batches meet specified impurity limits.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability studies of Valproic Acid formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Process Chemistry: Used in research to understand the formation pathways of this impurity, aiding in the optimization of synthetic routes and purification processes.

Basic Information

Product Name	Valproic Acid Impurity 7
CAS No.	72999-08-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2-Propylpentanoic Acid Impurity 7; Valproate Impurity 7; Depakene Impurity 7; 2-Propylvaleric Acid Related Compound 7; Valproic Acid Related Substance 7; Valproic Acid EP Impurity G (Check for correlation); Valproic Acid USP Related Compound (Check for correlation)
EINECS	Contact for details

Quality Control

Our Valproic Acid Impurity 7 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay. Our quality commitment aligns with the requirements for chemical reference standards used in GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The container should be kept securely sealed when not in use to protect the integrity of the material.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on dried basis)
Related Impurities (HPLC)	Individual unknown ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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