Description

Butylphthalide Impurity is a high-purity chemical reference standard used for analytical and research purposes. It serves as a critical marker for the identification, quantification, and control of related substances in the active pharmaceutical ingredient (API) Butylphthalide. This compound is essential for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on quality assurance and method development for stroke treatment medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the analysis of Butylphthalide API.
• Analytical Method Development: Used in HPLC, GC, and LC-MS methods to establish system suitability, retention times, and detection limits.
• Impurity Profiling & Qualification: Critical for identifying and quantifying process-related impurities and degradation products in Butylphthalide drug substances and products.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Acts as a benchmark to monitor the formation of degradation impurities under various stress conditions.
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs) and New Drug Applications (NDAs) by providing impurity characterization data.
• Research & Development: Utilized in synthetic chemistry R&D for route scouting and process optimization to minimize this specific impurity.

Basic Information

Product Name	Butylphthalide Impurity
CAS No.	685886-82-2
Molecular Formula	C12H14O2
Molecular Weight	190.24 g/mol
Synonyms	3-Butylisobenzofuran-1(3H)-one; 3-n-Butylphthalide; Butylphthalide Related Compound; Butylphthalide Impurity Standard; DL-3-n-Butylphthalide Impurity; (±)-3-Butylphthalide Impurity; NBP Impurity
EINECS	Contact for details

Quality Control

Every batch of Butylphthalide Impurity CAS NO 685886-82-2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with ICH guidelines and customer-specific requirements. 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 in a cool, dry place at a controlled room temperature (15-25°C). The material is moisture-sensitive; keep the container tightly sealed in a dry environment.

Specification

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

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