Description

Diquafosol Impurity 12 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Diquafosol Tetrasodium, an active pharmaceutical ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Diquafosol Tetrasodium impurities in drug substances and products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing in pharmaceutical manufacturing to ensure product purity and regulatory compliance.
• Stability Studies: Employed to track the formation of degradation products in Diquafosol formulations under various storage conditions.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Research & Development: Used in synthetic chemistry and pharmacology research to study the metabolism and degradation pathways of Diquafosol.

Basic Information

Product Name	Diquafosol Impurity 12
CAS No.	694434-51-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diquafosol Related Compound 12; INS 365 Impurity 12; Uridine 5'-(tetrahydrogen triphosphate), P'→5'-ester with 2'-deoxycytidine 3'-(dihydrogen phosphate); Diquafosol Tetrasodium Impurity 12; P1-(2'-Deoxycytidin-5'-yl) P4-(uridin-5'-yl) tetraphosphate impurity; Potential degradation product of Diquafosol; Diquafosol Process Impurity
EINECS	Contact for details

Quality Control

Our Diquafosol Impurity 12 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data, chromatograms, and traceability information. Our quality commitment aligns with cGMP principles to support your regulatory and compliance needs.

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 in a desiccated environment to maintain stability and purity. Handle the container with care to prevent ingress of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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