Description

Tenofovir Related Compound 3 is a high-purity chemical reference standard and synthetic intermediate of significant importance in pharmaceutical research and development. Its primary value lies in its critical role in the quality control and analytical profiling of Tenofovir and its related drug substances, ensuring the safety and efficacy of final pharmaceutical products. This compound is essential for laboratories and manufacturers engaged in the development, validation, and production of antiviral medications, particularly for use as an impurity standard in HPLC analysis.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) active pharmaceutical ingredients (APIs).
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor process-related impurities and ensure drug purity.
• Process Chemistry Research: Serves as a key intermediate or a model compound in synthetic route research and optimization for nucleotide reverse transcriptase inhibitors.
• Quality Assurance/Quality Control (QA/QC): Employed in in-house quality control laboratories of API manufacturers and finished dosage form producers to comply with ICH guidelines.
• Regulatory Submissions: Used to characterize and qualify impurities for regulatory filings with agencies such as the FDA, EMA, and PMDA.
• Academic and Contract Research: Utilized in universities and CROs for pharmacological studies and stability testing of antiviral drug formulations.

Basic Information

Item	Details
Product Name	Tenofovir Related Compound 3
CAS No.	52364-31-5
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine; PMPA Impurity; Tenofovir Impurity C; GS 1278 Related Compound; (R)-PMPA Adefovir Intermediate; Adefovir Dipivoxil Related Substance; 9-[2-(Phosphonomethoxy)propyl]adenine Analog
EINECS	Contact for details

Quality Control

Our Tenofovir Related Compound 3 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against stringent in-house specifications aligned with ICH Q3A/B guidelines. Our commitment to traceability and consistency ensures reliability for your critical analytical and regulatory 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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions (e.g., nitrogen atmosphere) after opening to prevent degradation. For long-term storage, desiccants are recommended.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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