Description

Diquafosol Impurity Up2U is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critically important for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of Diquafosol Tetrasodium, an active pharmaceutical ingredient. It serves as a key impurity marker for method development, validation, and routine batch testing in the production of ophthalmic solutions. Professionals in pharmaceutical R&D, quality assurance, and regulatory compliance rely on this standard to meet stringent pharmacopeial requirements.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Diquafosol Tetrasodium API.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control laboratories.
• Essential for stability studies and degradation pathway analysis of ophthalmic drug formulations.
• Used in regulatory submissions to agencies like the FDA and EMA to demonstrate comprehensive impurity profiling.
• Serves as a system suitability test component in pharmacopeial monographs and in-house testing protocols.
• Supports process chemistry research for the optimization and scale-up of Diquafosol synthesis.
• Utilized by contract research organizations (CROs) and testing laboratories for client impurity analysis projects.

Basic Information

Product Name	Diquafosol Impurity Up2U
CAS No.	221169-12-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diquafosol Related Compound Up2U; Diquafosol Impurity 2; Diquafosol EP Impurity Up2U; Diquafosol Process Impurity; Uridine 5'-(tetrahydrogen triphosphate), P'→5'-ester with 2-(dihydrogen phosphate)inosine; INS 365 Impurity; P1-(2'-Deoxyinosin-5'-yl) P4-(uridin-5'-yl) tetraphosphate impurity
EINECS	Contact for details

Quality Control

Every batch of Diquafosol Impurity Up2U is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards.

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 under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Reported on COA
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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