Description

Butyphthalide Impurity 43 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 the active pharmaceutical ingredient Butyphthalide, ensuring the safety and efficacy of the final drug product. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in method development, stability studies, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Butyphthalide API batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control & Assurance: Essential for in-process testing and release testing of Butyphthalide to ensure compliance with pharmacopeial standards (e.g., USP, EP, ChP).
• Regulatory Submissions: Provides necessary data on impurity structure and behavior for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Synthesis: Acts as a building block or intermediate for synthetic chemists exploring related chemical structures or metabolic pathways.

Basic Information

Item	Detail
Product Name	Butyphthalide Impurity 43
CAS No.	952412-99-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butyphthalide Related Compound 43; Butylphthalide Impurity 43; 3-Butyl-1(3H)-isobenzofuranone Impurity 43; DL-3-n-Butylphthalide Impurity 43; NBP Impurity 43; (RS)-3-Butylphthalide Impurity 43; Butyphthalide EP Impurity C; Butyphthalide USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Butyphthalide Impurity 43 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available for audit and regulatory review.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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