Description

Butyphthalide Impurity 36 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Butyphthalide, an active pharmaceutical ingredient used in the treatment of ischemic stroke. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantification and identification of related substances in Butyphthalide Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity profiling.
• Stability Studies & Forced Degradation: Employed as a marker to monitor impurity formation during drug substance and product stability testing under various stress conditions.
• Quality Control & Batch Release: Essential for establishing specification limits and ensuring batch-to-batch consistency of the API in compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding the synthetic pathway and impurity formation mechanisms during the manufacturing of Butyphthalide.

Basic Information

Product Name	Butyphthalide Impurity 36
CAS No.	2245275-82-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butyphthalide Related Compound 36; Butylphthalide Impurity 36; 3-Butyl-1(3H)-isobenzofuranone Impurity 36; DL-3-n-Butylphthalide Impurity 36; NBP Impurity 36; (RS)-3-Butylphthalide Impurity 36; Butyphthalide EP Impurity B; Butyphthalide USP Impurity B
EINECS	Contact for details

Quality Control

Our Butyphthalide Impurity 36 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

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 conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 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.