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 efficacy of the active pharmaceutical ingredient (API) Butylphthalide through precise identification and quantification of related substances. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The material is supplied with comprehensive analytical data to support method validation and regulatory compliance.

Application

• Primary use as a certified reference standard for the analysis of Butylphthalide (NBP) API.
• Identification and quantification of related substances in pharmaceutical quality control (QC) and quality assurance (QA) processes.
• Method development and validation for HPLC, GC, and LC-MS analytical techniques in research laboratories.
• Calibration of analytical instruments to ensure accurate impurity profiling for regulatory submissions (e.g., ICH guidelines Q3A(R2) and Q3B(R2)).
• Stability studies and forced degradation studies to understand the degradation pathways of Butylphthalide.
• Use in academic and institutional research focused on the chemistry and pharmacology of Butylphthalide and its analogs.

Basic Information

Product Name	Butylphthalide Impurity
CAS No.	20871-40-3
Molecular Formula	C12H14O2
Molecular Weight	190.24 g/mol
Synonyms	3-Butylphthalide; 3-Butyl-1(3H)-isobenzofuranone; 3-n-Butylphthalide; dl-3-Butylphthalide; Butylphthalide Related Compound; Butylphthalide Impurity A; NBP Impurity; L-Butylphthalide Impurity
EINECS	Contact for details

Quality Control

Every batch of Butylphthalide Impurity CAS 20871-40-3 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including chromatographic purity assay and identity confirmation, to ensure it meets the exacting standards required for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and analytical methods. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere such as argon or nitrogen.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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