Description

Foscarnet Impurity B is a critical pharmaceutical reference standard used for analytical and quality control purposes. This compound is essential for ensuring the purity, safety, and efficacy of the antiviral drug Foscarnet, a key medication for treating cytomegalovirus (CMV) retinitis in immunocompromised patients. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of Foscarnet Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for Foscarnet analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Foscarnet.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Utilized in synthetic chemistry R&D to study the formation and mitigation of this specific impurity during the manufacturing process.

Basic Information

Product Name	Foscarnet Impurity B
CAS No.	55920-24-6
Molecular Formula	C5H4N3O4Na
Molecular Weight	193.10 g/mol
Synonyms	Sodium 5-cyano-2,4-dihydroxypyrimidine-6-olate; 6-Cyano-2,4-dihydroxy-5-pyrimidinecarboxylic acid sodium salt; Trisodium phosphonoformate impurity B; PFA Impurity B; Phosphonoformic acid trisodium salt impurity B; 5-Cyano-2,4-dihydroxypyrimidine-6-carboxylic acid sodium salt
EINECS	Contact for details

Quality Control

Our Foscarnet Impurity B is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%

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