Description

Annonacin Impurity 1 (5-(3-Methyl-Butyl)-3H-Furan-2-One) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity in the analysis of annonacin, a bioactive acetogenin, ensuring the accuracy and reliability of analytical methods. It is primarily required by analytical chemists and quality assurance professionals in the pharmaceutical, nutraceutical, and academic research sectors for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of annonacin-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and LC-MS, for annonacin analysis.
• Quality Control (QC) & Quality Assurance (QA): Provides a benchmark for in-house testing to ensure batch-to-batch consistency and purity of annonacin extracts or synthetic materials.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing a characterized impurity standard for stability studies and specification setting.
• Academic & Biomedical Research: Employed in studies investigating the chemistry, metabolism, and toxicological profile of annonacin and related acetogenins.
• Nutraceutical & Herbal Supplement Analysis: Used to assess the purity and safety of annonacin-containing natural products and dietary supplements.

Basic Information

Product Name	Annonacin Impurity 1
CAS No.	81715-82-4
Molecular Formula	C9H14O2
Molecular Weight	154.21 g/mol
Synonyms	5-(3-Methylbutyl)-3H-furan-2-one; 5-(3-Methylbutyl)dihydrofuran-2(3H)-one; 5-(3-Methylbutyl)-2(3H)-furanone; Annonacin Related Compound; 3-Methylbutyl-γ-butyrolactone; γ-(3-Methylbutyl)-γ-butyrolactone; (RS)-5-(3-Methylbutyl)dihydrofuran-2(3H)-one
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Annonacin Impurity 1 is characterized using advanced analytical techniques to confirm identity, purity, and stability. Certificates of Analysis (COA) are provided, detailing results from HPLC, NMR, and mass spectrometry. We adhere to GMP principles in our manufacturing and control processes to support your regulatory and research requirements.

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 stability, consider storage at 2-8°C. Keep the container sealed to prevent moisture absorption and contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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