Description

Butylphthalide Impurity 40 is a high-purity chemical reference standard, specifically identified as an impurity of the active pharmaceutical ingredient (API) Butylphthalide. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control processes. It is essential for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical industry who require reliable standards to ensure the purity, safety, and efficacy of their drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Butylphthalide Impurity 40 in API and finished drug products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions during drug stability testing.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification of Butylphthalide.

Basic Information

Product Name	Butylphthalide Impurity 40
CAS No.	1485081-46-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butylphthalide Related Compound 40; Butylphthalide Impurity B; Butylphthalide EP Impurity 40; Butylphthalide USP Impurity; 3-Butyl-1(3H)-isobenzofuranone Impurity 40; DL-3-n-Butylphthalide Impurity 40; NBP Impurity 40; (RS)-3-Butylphthalide Impurity 40
EINECS	Contact for details

Quality Control

Every batch of Butylphthalide Impurity 40 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis/label. Keep the container in a dry, well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.