Description

Butyphthalide Impurity 38 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Butyphthalide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Butyphthalide API.
• Analytical Method Development: Used as a standard to develop and validate HPLC, UPLC, or GC methods for quality control testing.
• Stability Studies: Employed to monitor the formation of degradation products in Butyphthalide formulations under various storage conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Quality Control (QC) Testing: Acts as a system suitability standard in routine QC labs to ensure the accuracy and precision of impurity assays.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the fate of related substances.

Basic Information

Product Name	Butyphthalide Impurity 38
CAS No.	1841089-56-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butyphthalide Related Compound 38; Butylphthalide Impurity 38; 3-Butyl-1(3H)-isobenzofuranone Impurity 38; Dl-3-n-Butylphthalide Impurity 38; NBP Impurity 38; (RS)-3-Butylphthalide Impurity 38; Butyphthalide EP Impurity B; Butyphthalide USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Butyphthalide Impurity 38 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

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)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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