Description

Diquafosol Impurity Up3U is a high-purity reference standard and impurity used in pharmaceutical research and development. This compound is critical for analytical method development, validation, and quality control processes to ensure the safety and efficacy of the final drug product. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the production and testing of Diquafosol Tetrasodium and related ophthalmic formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Diquafosol Tetrasodium.
• Impurity Profiling: Essential for identifying, characterizing, and quantifying process-related impurities and degradation products in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Serves as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data on impurity identity and qualification for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Stability Studies: Used to track the formation of specific impurities under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.

Basic Information

Product Name	Diquafosol Impurity Up3U
CAS No.	401618-61-9
Molecular Formula	C18H25N5O19P4
Molecular Weight	733.33 g/mol
Synonyms	Diquafosol Related Compound Up3U; P1,P4-Di(uridine-5'-) tetraphosphate impurity; INS 365 Impurity Up3U; Uridine 5'-(tetrahydrogen tetraphosphate) 5'-5'-ester with uridine impurity; Diquafosol Tetrasodium Impurity Up3U; P1,P4-Diuridine-5'-tetraphosphate; Diuridine tetraphosphate impurity
EINECS	Contact for details

Quality Control

Our Diquafosol Impurity Up3U is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH Q3A, Q3B, and Q6A guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results, methods, and acceptance criteria is provided with every shipment.

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 atmosphere or desiccated conditions upon 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%
Related Substances (HPLC)	Individual unspecified 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.