Description

Diclofenac Glyceryl Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critically important for pharmaceutical quality control, specifically in the development and validation of analytical methods for Diclofenac-based drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Diclofenac active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to ensure accurate detection and separation from the main drug compound.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life and storage guidelines.
• Quality Control and Batch Release Testing: Serves as a primary standard in routine QC laboratories to confirm that drug substances and products meet predefined impurity limits as per ICH, USP, or EP guidelines.
• Regulatory Submissions and Compliance: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in R&D to study the degradation pathways of Diclofenac and to synthesize and characterize related substances for comprehensive impurity control.

Basic Information

Product Name	Diclofenac Glyceryl Impurity
CAS No.	221016-39-3
Molecular Formula	C20H21Cl2NO5
Molecular Weight	426.29 g/mol
Synonyms	2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid, 2,3-dihydroxypropyl ester; Diclofenac 1-Glyceryl Ester; Diclofenac Glyceride Impurity; Glyceryl Diclofenate; 1-O-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetyl]glycerol; Diclofenac Glyceryl Ester; Diclofenac EP Impurity G; (RS)-1,2-Dihydroxy-3-[2-[(2,6-dichlorophenyl)amino]phenylacetoxy]propane
EINECS	Contact for details

Quality Control

Our Diclofenac Glyceryl Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, GC, NMR, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profiles, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

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, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

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

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