Description

Butylphthalide Impurity CAS NO 122654-56-2 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity or degradation product of dl-3-n-Butylphthalide (NBP), a key active pharmaceutical ingredient used in the treatment of ischemic stroke. It is essential for analytical chemists and quality control laboratories to ensure the safety, efficacy, and regulatory compliance of the final drug product. This impurity standard is indispensable for method development, validation, and routine batch release testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in dl-3-n-Butylphthalide (NBP) active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles throughout the drug lifecycle.
• Quality Control & Batch Release: Used in QC laboratories to establish acceptance criteria and ensure every batch of NBP API meets stringent pharmacopeial (e.g., ChP, USP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to determine drug shelf-life and optimal storage conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (IND, NDA, ANDA) to demonstrate comprehensive understanding and control of the drug substance's impurity profile.
• Research on Degradation Pathways: Aids pharmaceutical scientists in elucidating the chemical degradation pathways of Butylphthalide, leading to more stable formulations.

Basic Information

Item	Details
Product Name	Butylphthalide Impurity
CAS No.	122654-56-2
Molecular Formula	C12H14O2
Molecular Weight	190.24 g/mol
Synonyms	3-n-Butylphthalide Related Compound; Butylphthalide Specified Impurity; dl-3-n-Butylphthalide Impurity; 3-Butyl-1(3H)-isobenzofuranone isomer; NBP Impurity; Butylphthalide Degradation Product; (3R)-3-Butyl-3a,4,7,7a-tetrahydro-1H-isoindole-1,3(2H)-dione (related structure); Butylphthalide EP Impurity
EINECS	Contact for details

Quality Control

Every batch of Butylphthalide Impurity (CAS 122654-56-2) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage under an inert atmosphere, please contact our technical team for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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