Description

Diquafosol Impurity 1 is a specified impurity of the ophthalmic drug Diquafosol tetrasodium, identified by the CAS registry number 26184-65-6. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this impurity during drug substance and product manufacturing. It is an essential material for analytical method development, validation, and quality assurance in pharmaceutical laboratories. Professionals in pharmaceutical R&D, quality control, and regulatory affairs rely on this well-characterized impurity to ensure product safety and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Diquafosol tetrasodium.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical quality control laboratories to monitor impurity levels.
• Stability Studies: Employed in forced degradation and long-term stability studies of Diquafosol drug products to identify and track impurity formation.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopeial Testing: Supports testing in compliance with USP, EP, JP, or ICH guidelines for impurities in new drug substances and products (ICH Q3A & Q3B).

Basic Information

Product Name	Diquafosol Impurity 1
CAS No.	26184-65-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diquafosol Related Compound 1; Diquafosol EP Impurity A; Diquafosol USP Impurity A; Uridine 5'-(tetrahydrogen triphosphate), P'→5'-ester with 2'-deoxycytidine; 2'-Deoxycytidylyl-(3'→5')-uridine 5'-(trihydrogen triphosphate); INS 365 Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Diquafosol Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including purity, chromatographic data, and structural confirmation. We support compliance with ICH, USP, and EP guidelines for impurity qualification.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. For long-term storage, keep the container in a cool, dry, and well-ventilated area. Handle the material in accordance with safe laboratory practices.

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%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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