Description

Butyphthalide Impurity 27 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the active pharmaceutical ingredient Butyphthalide. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable impurity standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Butyphthalide Impurity 27 in drug substances and products.
• Analytical Method Development: Used in HPLC, LC-MS, and GC-MS method development and validation to establish specificity, accuracy, and detection limits.
• Quality Control & Assurance (QC/QA): A critical component in the impurity profiling and batch release testing of Butyphthalide API to meet ICH guidelines.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability studies of pharmaceutical formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Butyphthalide Impurity 27
CAS No.	33704-16-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butyphthalide Related Compound 27; Butylphthalide Impurity B; 3-Butyl-1(3H)-isobenzofuranone Impurity 27; DL-3-n-Butylphthalide Impurity 27; NBP Impurity 27; (RS)-3-Butylphthalide Impurity 27; 3-Butylphthalide Related Substance 27
EINECS	Contact for details

Quality Control

Every batch of Butyphthalide Impurity 27 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. We support compliance with ICH Q3A/B and USP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.