Description

Butylphthalide Impurity CAS NO 380905-48-6 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 the active pharmaceutical ingredient (API) Butylphthalide, a neuroprotective agent. It serves as an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is fundamental for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Identification: Primary use as a certified reference standard for the identification and quantification of specific impurities in Butylphthalide API and its formulations.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, GC) to ensure accurate impurity detection.
• Quality Control and Assurance (QC/QA): Used in routine batch release testing of Butylphthalide to confirm it meets pharmacopeial (e.g., ChP, USP) and internal purity specifications.
• Stability Studies: Employed to monitor the formation of degradation products in Butylphthalide drug substances and products under various stress conditions.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Supports synthetic chemistry research, metabolic studies, and toxicological evaluations related to Butylphthalide.

Basic Information

Product Name	Butylphthalide Impurity
CAS No.	380905-48-6
Molecular Formula	C12H14O2
Molecular Weight	190.24 g/mol
Synonyms	Butylphthalide Related Compound; Butylphthalide Impurity Standard; 3-Butyl-1(3H)-isobenzofuranone impurity; dl-3-n-Butylphthalide Impurity; NBP Impurity; (±)-3-Butylphthalide Impurity; 3-n-Butylphthalide Related Substance
EINECS	Contact for details

Quality Control

Our Butylphthalide Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is characterized using advanced techniques including HPLC, GC, NMR, and mass spectrometry. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality system is designed to support the stringent requirements of pharmaceutical reference standard applications.

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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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