Description

Butylphthalide Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Butylphthalide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Butylphthalide Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or GC methods to monitor impurity levels during API synthesis and purification.
• Quality Control & Assurance: Serves as a system suitability standard in quality control laboratories to ensure analytical procedures are performing correctly for impurity detection.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data required for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and growth of this specific impurity over time.
• Process Chemistry Research: Used by chemists to study synthetic pathways, optimize reaction conditions, and minimize the formation of this impurity during Butylphthalide manufacturing.

Basic Information

Product Name	Butylphthalide Impurity
CAS No.	20871-32-3
Molecular Formula	C12H14O2
Molecular Weight	190.24 g/mol
Synonyms	3-Butyl-1(3H)-isobenzofuranone; 3-n-Butylphthalide; dl-3-Butylphthalide; Butylphthalide Related Compound; Butylphthalide EP Impurity; Butylphthalide USP Impurity; NBP Impurity; L-3-n-Butylphthalide Impurity
EINECS	Contact for details

Quality Control

Every batch of Butylphthalide Impurity CAS 20871-32-3 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity assay and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. Handle and store under inert conditions if specified for the specific grade.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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