Description

Diosmin Impurity 14 is a high-purity chemical reference standard, specifically identified as a key impurity in the Diosmin manufacturing process. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure final product safety and efficacy. It is primarily utilized by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and nutraceutical industries for method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Diosmin Impurity 14 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in Diosmin.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the sensitivity and specificity of impurity detection methods.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions and over shelf-life studies.
• Process Chemistry Research: Used by chemists to study and optimize synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Diosmin Impurity 14
CAS No.	34280-05-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diosmin Related Compound 14; 3',5,7-Trihydroxy-4'-methoxyflavone 7-rutinoside impurity; Diosmin EP Impurity 14; Diosmin USP Impurity 14; Flavonoid glycoside impurity; 7-[[6-O-(6-Deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one (related substance)
EINECS	Contact for details

Quality Control

Every batch of Diosmin Impurity 14 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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