Description

Diquafosol Impurity Up7U is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient Diquafosol Tetrasodium by accurately identifying and quantifying related substances. It is an essential material for researchers and quality assurance professionals in the pharmaceutical and biotechnology industries who require reliable impurity standards for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Up7U impurity in Diquafosol Tetrasodium drug substance and drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for purity analysis.
• Stability Studies & Forced Degradation: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Quality Control & Batch Release: Essential for in-house QC laboratories to ensure drug substance and finished product batches meet stringent impurity limits as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug's impurity profile.
• Contract Research & Manufacturing (CRO/CMO): Used by service organizations to support client projects requiring precise impurity analysis and control.

Basic Information

Product Name	Diquafosol Impurity Up7U
CAS No.	330960-16-2
Molecular Formula	C18H25N6Na4O19P4
Molecular Weight	814.27 g/mol
Synonyms	P1,P4-Di(uridine-5'-) tetraphosphate tetrasodium salt impurity; Diquafosol Tetrasodium Impurity Up7U; Uridine-5'-tetraphosphate P1,P4-di(uridine-5'-) ester tetrasodium salt; INS 365 Impurity; INS365 Impurity Up7U; Diquafosol Related Compound Up7U; 5'-UDP-5'-U tetrasodium salt
EINECS	Contact for details

Quality Control

Our Diquafosol Impurity Up7U is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR for definitive structural confirmation and purity assessment. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. Our quality system is designed to support compliance with cGMP and ICH Q3A/B guidelines for impurities in new drug substances and products.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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 unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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