Description

Diosmin Impurity 19 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Diosmin, a key pharmaceutical ingredient. It is primarily required by analytical laboratories and pharmaceutical manufacturers engaged in method development, validation, and impurity profiling. This standard is essential for maintaining stringent quality control in the production of Diosmin-based pharmaceuticals.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Diosmin Impurity 19 in Diosmin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: A critical component for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Diosmin.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to ensure product purity meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Diosmin formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development (R&D): Serves as a key material in pharmaceutical R&D for studying the degradation pathways and metabolism of Diosmin.

Basic Information

Product Name	Diosmin Impurity 19
CAS No.	67549-69-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diosmin Related Compound; Diosmin Impurity; Diosmin EP Impurity; Diosmin USP Impurity; 3',5,7-Trihydroxy-4'-methoxyflavone 7-rutinoside impurity; Hesperidin derivative impurity; Flavonoid glycoside impurity
EINECS	Contact for details

Quality Control

Every batch of Diosmin Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic techniques (HPLC, LC-MS) to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to light yellow powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report individual and total impurities
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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