Description

Butylphthalide Impurity 29 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the active pharmaceutical ingredient Butylphthalide. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products during development and manufacturing. It is primarily used by analytical laboratories, quality control departments, and research scientists in the pharmaceutical industry for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as an authentic reference standard for the identification and quantification of Butylphthalide Impurity 29 in drug substances and finished products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, GC) to monitor this specific impurity.
• Quality Control and Batch Release Testing: Used as a system suitability standard and for preparing calibration curves in routine QC testing to ensure drug purity meets pharmacopeial limits.
• Stability Studies and Forced Degradation: Employed to track the formation of this impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Used in synthetic chemistry R&D to understand and minimize the formation of this impurity during the API manufacturing process.

Basic Information

Product Name	Butylphthalide Impurity 29
CAS No.	64002-57-9
Molecular Formula	C12H14O2
Molecular Weight	190.24 g/mol
Synonyms	3-Butylisobenzofuran-1(3H)-one; 3-Butylphthalide; 3-n-Butylphthalide Impurity 29; Butylphthalide Related Compound 29; DL-3-n-Butylphthalide Impurity; NBP Impurity 29; 1(3H)-Isobenzofuranone, 3-butyl-
EINECS	Contact for details

Quality Control

Every batch of Butylphthalide Impurity 29 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

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)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
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.