Description

Diosmin Impurity 18 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Diosmin, a key pharmaceutical ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing of Diosmin-based products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Diosmin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to identify, quantify, and characterize Diosmin Impurity 18 in complex matrices.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling of Diosmin.
• Stability Studies: Employed as a marker to monitor the formation and level of this specific impurity during forced degradation and long-term stability studies of Diosmin.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the behavior of Diosmin and its related substances.
• Calibration & System Suitability: Acts as a calibrant to ensure the precision and accuracy of chromatographic systems used in purity assays.

Basic Information

Product Name	Diosmin Impurity 18
CAS No.	28719-21-3
Molecular Formula	C28H32O15
Molecular Weight	608.55 g/mol
Synonyms	Diosmetin 7-O-rutinoside Impurity 18; 3',5,7-Trihydroxy-4'-methoxyflavone 7-rutinoside Impurity; Diosmin Related Compound 18; 4'-Methylluteolin 7-rutinoside Impurity; Flavonoid Impurity 18; Diosmin EP Impurity 18; Diosmin USP Impurity 18
EINECS	Contact for details

Quality Control

Every batch of Diosmin Impurity 18 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification (IR, NMR, MS), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

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 and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%
Heavy Metals	≤ 20 ppm

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