Description

Diquafosol Impurity 3 is a specified impurity of the pharmaceutical agent Diquafosol tetrasodium, used as a critical reference standard in analytical development and quality control. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during manufacturing and regulatory submission. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in ophthalmic drug development and production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Diquafosol-related impurities in API and finished drug products.
• Analytical Method Development & Validation: Used in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Diquafosol tetrasodium.
• Quality Control & Batch Release Testing: Critical for setting impurity acceptance criteria and conducting routine quality control testing of pharmaceutical batches.
• Stability Studies: Employed to monitor impurity profiles in forced degradation and long-term stability studies of Diquafosol formulations.
• Regulatory Compliance & Filing: Supports regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Diquafosol tetrasodium.

Basic Information

Product Name	Diquafosol Impurity 3
CAS No.	211448-70-3
Molecular Formula	C18H25N6Na4O19P4
Molecular Weight	846.26 g/mol
Synonyms	Diquafosol Related Compound 3; INS 365 Impurity 3; P1,P4-Di(adenosine-5') tetraphosphate tetrasodium salt impurity; Adenosine-5'-(tetrahydrogen tetraphosphate) P1,P4-di(ester) with adenosine tetrasodium salt impurity; Ap4A tetrasodium salt impurity; Diadenosine tetraphosphate tetrasodium impurity
EINECS	Contact for details

Quality Control

Our Diquafosol Impurity 3 is manufactured under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure high purity and structural identity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH Q3A/B guidelines.

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 inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
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.