Description

Diquafosol Impurity Up4 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity and safety of Diquafosol Tetrasodium, an active pharmaceutical ingredient. It serves as a key impurity marker in the development, validation, and routine testing of ophthalmic drug products. Professionals in pharmaceutical R&D and quality assurance rely on this standard for method development and regulatory compliance.

Application

• Primary use as a reference standard for the identification and quantification of Diquafosol Tetrasodium impurities.
• Critical component in analytical method development and validation (HPLC, LC-MS) for pharmaceutical quality control.
• Used in stability studies and forced degradation studies to profile impurity formation in drug substances and products.
• Essential for regulatory submissions (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Supports research and development of purer synthetic pathways for Diquafosol and related compounds.
• Employed by contract research organizations (CROs) and testing laboratories for client-specific analytical projects.

Basic Information

Product Name	Diquafosol Impurity Up4
CAS No.	401618-90-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diquafosol Related Compound Up4; Diquafosol Impurity 4; INS 365 Impurity Up4; P1,P4-Di(uridine 5'-) tetraphosphate impurity; Uridine 5'-(tetrahydrogen tetraphosphate) P'→5'-ester with uridine impurity; Diquafosol Tetrasodium Impurity Up4; INS365 Up4
EINECS	Contact for details

Quality Control

Every batch of Diquafosol Impurity Up4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
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.