Description

Oryzanol Impurity 1 CAS NO 20972-10-5 is a high-purity reference standard used for analytical and research purposes. This compound is critical for quality control and method development in the pharmaceutical and nutraceutical industries, specifically for the analysis of γ-Oryzanol and related products. It is an essential material for laboratories requiring precise identification, quantification, and validation of impurities to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control of γ-Oryzanol active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, and GC analytical methods in compliance with ICH guidelines.
• Nutraceutical & Dietary Supplement Testing: Serves as a key marker for impurity profiling and assay determination in rice bran oil extracts and related health supplements.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Research & Development: Utilized in metabolic studies, stability testing, and degradation pathway research for γ-Oryzanol-containing formulations.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch testing to monitor impurity levels and ensure consistency in manufacturing processes.

Basic Information

Product Name	Oryzanol Impurity 1
CAS No.	20972-10-5
Molecular Formula	C40H58O4
Molecular Weight	602.89 g/mol
Synonyms	Cycloartenyl Ferulate; 24-Methylenecycloartanyl Ferulate; γ-Oryzanol Impurity 1; Ferulic Acid Cycloartenyl Ester; Cycloartenol Ferulate; (24Z)-24-Methylenecycloartan-3β-yl (E)-3-(4-hydroxy-3-methoxyphenyl)prop-2-enoate; Oryzanol Related Compound A; NSC 83259
EINECS	Contact for details

Quality Control

Our Oryzanol Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results. We support compliance with ICH Q3B guidelines for impurities and can supply materials suitable for pharmaceutical development.

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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed and in original packaging until use to prevent degradation. For long-term storage, consider desiccants and inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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