Description

Triricinolein Impurity 4 is a high-purity chemical reference standard, specifically identified as an impurity of the triglyceride triricinolein. This compound is critical for analytical method development, validation, and quality control in the pharmaceutical and fine chemical industries. It is primarily used by researchers and quality assurance professionals requiring precise quantification of related substances in ricinoleic acid-derived products, such as castor oil and its derivatives.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material (CRM) for the identification and quantification of process-related impurities in active pharmaceutical ingredients (APIs) derived from castor oil.
• Analytical Method Development: Used as a critical standard to develop and validate HPLC, GC, and LC-MS methods for triglyceride and fatty acid analysis.
• Quality Control & Assurance: Essential for establishing specification limits and ensuring batch-to-batch consistency in the manufacture of high-purity ricinoleates and their polymers.
• Research & Development: A key tool in metabolic studies, lipidomics research, and the synthesis of novel biodegradable polymers from renewable resources.
• Regulatory Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug substance and product applications.

Basic Information

Product Name	Triricinolein Impurity 4
CAS No.	303082-20-4
Molecular Formula	C57H104O9
Molecular Weight	933.43 g/mol
Synonyms	Glyceryl Triricinoleate Impurity 4; 1,2,3-Tris[(12R)-12-hydroxy-9-octadecenoyl]glycerol impurity; Triricinolein Related Compound 4; Ricinoleic Acid Triglyceride Impurity; Castor Oil Triglyceride Impurity; (R)-Triricinolein Impurity 4; 9-Octadecenoic acid, 12-hydroxy-, (9Z,12R)-, 1,2,3-propanetriyl ester impurity
EINECS	Contact for details

Quality Control

Every batch of Triricinolein Impurity 4 is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation and purity analysis using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure it meets the exacting standards required for reference materials. 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) in a dry environment. For long-term storage under inert atmosphere, please contact our technical team for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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