Description

Butyphthalide Impurity 39 is a high-purity reference standard and synthetic intermediate of significant importance in pharmaceutical development and quality control. This compound is critical for the analytical characterization, method validation, and impurity profiling of Butyphthalide (DL-3-n-Butylphthalide), a key active pharmaceutical ingredient used in the treatment of ischemic stroke. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical testing laboratories to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Butyphthalide drug substances and products.
• Impurity Profiling and Control: Essential for identifying, monitoring, and controlling this specific impurity during API synthesis and formulation to meet ICH Q3A/B guidelines.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component for developing, optimizing, and validating stability-indicating assay methods.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (heat, light, humidity) as part of forced degradation studies.
• Process Chemistry Research: Used by R&D scientists to study reaction pathways, optimize synthesis routes, and improve the purity of the final Butyphthalide API.

Basic Information

Product Name	Butyphthalide Impurity 39
CAS No.	1841089-57-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butyphthalide Related Compound 39; Butylphthalide Impurity 39; 3-n-Butylphthalide Impurity 39; DL-3-n-Butylphthalide Impurity 39; NBP Impurity 39; (RS)-3-Butyl-1(3H)-isobenzofuranone Impurity 39; 1841089-57-3
EINECS	Contact for details

Quality Control

Every batch of Butyphthalide Impurity 39 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, and NMR to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided to support your regulatory and research needs.

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) and must be kept under inert atmosphere or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.