Description

Butyphthalide Impurity 44 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Butyphthalide, an active pharmaceutical ingredient used in the treatment of ischemic stroke. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in method development, stability studies, and regulatory compliance.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Butyphthalide API.
• Essential for analytical method development and validation (HPLC, LC-MS) in quality control laboratories.
• Used in stability studies and forced degradation studies to monitor impurity profiles.
• Critical component for regulatory filing and compliance (e.g., ICH guidelines Q3A, Q3B) for drug substance approval.
• Serves as a research-grade chemical in pharmacokinetic and metabolic pathway studies.
• Supports contract manufacturing organizations (CMOs) in ensuring batch-to-batch consistency and purity of final drug products.

Basic Information

Product Name	Butyphthalide Impurity 44
CAS No.	952413-01-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butyphthalide Related Compound 44; Butyphthalide Impurity B; 3-Butylphthalide Impurity 44; DL-3-n-Butylphthalide Impurity 44; NBP Impurity 44; (RS)-3-Butylphthalide Impurity 44; Butylphthalide Impurity 44
EINECS	Contact for details

Quality Control

Every batch of Butyphthalide Impurity 44 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.