Description

Diacerein Impurity F is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critically important for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Diacerein during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams for method validation, impurity profiling, and compliance documentation.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Diacerein Impurity F in Diacerein API and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor this specific impurity.
• Quality Control and Batch Release Testing: Employed in routine QC testing to ensure Diacerein batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Stability Studies and Forced Degradation Testing: Serves as a marker to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submission and Compliance: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Research and Development: Used in synthetic chemistry research to study the formation pathway and develop mitigation strategies for this impurity.

Basic Information

Product Name	Diacerein Impurity F
CAS No.	13928-72-8
Molecular Formula	C19H12O8
Molecular Weight	368.29 g/mol
Synonyms	1,8-Diacetoxy-3-carboxyanthraquinone; 1,8-Diacetoxyanthraquinone-3-carboxylic Acid; Diacetyl Rhein; Rhein Diacetate; Diacerein Related Compound F; Diacerein Impurity 6; CAS 13928-72-8
EINECS	Contact for details

Quality Control

Every batch of Diacerein Impurity F is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of the pharmaceutical industry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for tests including identification (HPLC, IR), assay (HPLC), and related substances. We support 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. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	Yellow to orange-yellow powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
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.