Description

Foscarnet Sodium Impurity 3 (Foscarnet Sodium EP Impurity C) is a high-purity chemical reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity for the antiviral drug Foscarnet Sodium, enabling accurate identification, quantification, and monitoring during drug development and manufacturing. It is an essential material for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and contract research organization (CRO) sectors who require reliable standards for method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Foscarnet Sodium EP Impurity C in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing data on impurity profiles as required by ICH Q3A and Q3B guidelines.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies of Foscarnet Sodium to understand impurity formation pathways.
• Pharmacopoeial Testing: Essential for testing to meet the specifications of the European Pharmacopoeia (EP) and other international pharmacopoeias for Foscarnet Sodium.
• Contract Research & Manufacturing (CRO/CMO): Provides a reliable standard for outsourcing partners to ensure consistent analytical results across different testing sites.

Basic Information

Product Name	Foscarnet Sodium Impurity 3 (Foscarnet Sodium EP Impurity C)
CAS No.	72304-94-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Foscarnet Sodium Impurity C; Phosphonoformic Acid Trisodium Salt Impurity; Trisodium phosphonoformate impurity; Foscarnet trisodium impurity; EP Impurity C of Foscarnet Sodium; Foscarnet Sodium Related Compound C; Trisodium (phosphonatooxy)formate impurity
EINECS	Contact for details

Quality Control

Every batch of Foscarnet Sodium Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Production can be aligned with current Good Manufacturing Practice (cGMP) principles for critical applications.

Storage

Preserve in a tightly closed container, protected from light. Due to its hygroscopic (moisture-sensitive) nature, the container should be stored in a cool, dry place, ideally under controlled room temperature (15-25°C) and low humidity conditions. For long-term storage, consider desiccants or inert atmosphere to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content	Contact for details
Residual Solvents	Complies with ICH Q3C

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