Description

Diquafosol Impurity 10 is a specified impurity of the pharmaceutical compound Diquafosol Tetrasodium, used in analytical research and development. This impurity standard is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during manufacturing and quality control processes. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method development, validation, and stability studies for ophthalmic drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Diquafosol Impurity 10 in Diquafosol Tetrasodium API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating precise HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure the impurity levels in commercial batches are within specified limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability and shelf-life determination.
• Regulatory Submissions: Provides necessary data on impurity characterization and control strategies for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Used by R&D scientists to understand and optimize synthetic pathways to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Diquafosol Impurity 10
CAS No.	22256-98-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diquafosol Related Compound; Diquafosol Tetrasodium Impurity 10; INS 365 Impurity; Uridine 5'-(tetrahydrogen tetraphosphate) P'→5'-ester with 2'(3')-O-(4,4'-dimethoxytrityl)uridine Impurity; P1,P4-Bis(5'-uridylyl) tetraphosphate Impurity; Diquafosol Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Diquafosol Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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