Description

Diosmin Impurity 17 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 pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development and validation. The availability of this well-characterized impurity standard is essential for accurate impurity profiling and control in Diosmin-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Diosmin Impurity 17 in Diosmin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS method development and validation to establish specificity, accuracy, and detection limits for this specific impurity.
• Quality Control & Assurance: Employed in routine batch release testing and stability studies of Diosmin to monitor impurity levels and ensure they remain within ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require complete impurity characterization and specification setting.
• Research & Degradation Studies: Utilized in forced degradation studies to understand the degradation pathways of Diosmin and to identify potential related substances.
• Pharmacopoeial Testing: Supports testing in compliance with monographs from pharmacopoeias such as USP, EP, or BP where control of related substances is mandated.

Basic Information

Product Name	Diosmin Impurity 17
CAS No.	89294-54-2
Molecular Formula	C28H32O15
Molecular Weight	608.55 g/mol
Synonyms	Diosmin Related Compound 17; 3',5,7-Trihydroxy-4'-methoxyflavone 7-rutinoside; Hesperetin 7-rutinoside; Isosakuranetin 7-rutinoside; 5-Hydroxy-2-(3-hydroxy-4-methoxyphenyl)-7-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-[[(2R,3R,4R,5R,6S)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxymethyl]oxan-2-yl]oxychromen-4-one; Diosmetin 7-O-rutinoside; Contact for details on additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Diosmin Impurity 17 is manufactured under a strict quality management system and undergoes comprehensive analytical testing. Our products are characterized using advanced techniques including NMR, MS, and HPLC to confirm identity and ensure high purity suitable for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, related substances, and residual solvents. We support compliance with ICH guidelines and relevant pharmacopoeial standards.

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)	Total impurities ≤ 5.0%
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.