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 rigorous impurity profiling and method validation. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on drug development and quality control. The material serves as a definitive benchmark for identifying and quantifying this specific impurity in compliance with international pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Butylphthalide Impurity CAS NO 16692-58-3 in Butylphthalide API batches.
• Analytical Method Development & Validation: Critical for developing, validating, and transferring HPLC, GC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to monitor impurity levels in Butylphthalide drug substances and products during forced degradation and long-term stability testing.
• Pharmacopeial Testing: Employed to ensure compliance with monographs in pharmacopeias such as USP, EP, or ChP where impurity limits are specified.
• Research & Development: Facilitates synthetic route optimization and impurity fate and tolerance studies during the API process development stage.

Basic Information

Product Name	Butylphthalide Impurity
CAS No.	16692-58-3
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 EP Impurity; Butylphthalide USP Impurity; NBP Impurity
EINECS	Contact for details

Quality Control

Every batch of Butylphthalide Impurity CAS NO 16692-58-3 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including chromatographic purity, identity confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data. Our quality commitment aligns with cGMP principles where applicable, supporting global regulatory compliance.

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 under an inert atmosphere is recommended to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time conforms to reference standard
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
Water Content (KF)	≤ 0.5% w/w

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