Description

Diquafosol Impurity 13 is a specified impurity of the pharmaceutical compound Diquafosol, a P2Y2 receptor agonist used in ophthalmic solutions. This impurity is a critical reference standard for analytical method development and validation, ensuring the purity and safety profile of the active pharmaceutical ingredient. It is essential for pharmaceutical manufacturers and analytical laboratories engaged in quality control, regulatory compliance, and research and development for ophthalmic drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Diquafosol Impurity 13 in drug substances and products.
• Analytical Method Development: Critical for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH guidelines.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity profiles and ensure drug substance purity meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (forced degradation studies).
• Research & Development: Facilitates process chemistry optimization to minimize the formation of this impurity during synthesis.

Basic Information

Item	Details
Product Name	Diquafosol Impurity 13
CAS No.	211448-81-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diquafosol Related Compound 13; Diquafosol EP Impurity C; Diquafosol USP Impurity; INS 365 Impurity; Uridine 5'-(tetrahydrogen triphosphate) P'-→5'-ester with 2',3'-O-(1-methylethylidene)uridine, Impurity; P1-(2',3'-O-Isopropylideneuridin-5'-yl) P2-uridin-5'-yl triphosphate; Diquafosol Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Diquafosol Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (MS, NMR) techniques to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

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%

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