Description

Diosmin Impurity 15 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the pharmaceutical active ingredient Diosmin. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing and research. It is primarily used by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and nutraceutical industries to ensure the purity, safety, and efficacy of Diosmin-based products.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Diosmin Impurity 15 in bulk drug substances and finished dosage forms.
• Analytical Method Development: Used as a critical component in developing and optimizing HPLC, UPLC, and LC-MS methods for Diosmin analysis.
• Quality Control & Assurance: Essential for routine batch testing in GMP environments to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker to track the formation of degradation products in Diosmin formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the impurity's behavior and toxicological profile.

Basic Information

Product Name	Diosmin Impurity 15
CAS No.	122087-66-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diosmin Related Compound 15; Diosmin EP Impurity 15; Diosmin USP Impurity 15; 7-[[6-O-(6-Deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one; Diosmin Degradant; Diosmin Process Impurity
EINECS	Contact for details

Quality Control

Our Diosmin Impurity 15 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures reliable and consistent material for your critical analytical work.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	Off-white to yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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