Description

Diquafosol Impurity 2 is a specified impurity and reference standard used in the analytical profiling and quality control of Diquafosol Tetrasodium, a pharmaceutical agent. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) involved in ophthalmic drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Diquafosol Impurity 2 in Diquafosol Tetrasodium API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines to ensure batch-to-batch consistency.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification reports required for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification stages of the API manufacturing process.

Basic Information

Item	Details
Product Name	Diquafosol Impurity 2
CAS No.	63785-59-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diquafosol Related Compound 2; Diquafosol EP Impurity B; Diquafosol USP Impurity; INS 365 Impurity; Uridine 5'-(tetrahydrogen triphosphate) impurity; P1-(5'-Uridyl) P4-(5'-uridyl) tetraphosphate impurity; Diquafosol Tetrasodium Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Diquafosol Impurity 2 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including identification by spectroscopic methods (e.g., NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. Our quality standards align with the requirements for pharmaceutical reference materials.

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 dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere in a desiccator.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%

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