Description

Tenofovir Related Compound 10 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for ensuring the quality, safety, and efficacy of antiviral drug products through precise analytical testing. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the synthesis and quality control of Tenofovir and its derivatives.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity or intermediate standard for the quality control of Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) active pharmaceutical ingredients (APIs).
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to identify, quantify, and characterize related substances in drug substances and finished products.
• Process Chemistry Research: Employed as a key intermediate or marker in studying and optimizing the synthetic pathways for Tenofovir-based therapeutics.
• Regulatory Compliance & Documentation: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Stability Studies: Acts as a benchmark for monitoring degradation products in stability testing of antiviral formulations.

Basic Information

Product Name	Tenofovir Related Compound 10
CAS No.	16958-60-4
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine; PMPA Isopropyl Carbonate; Tenofovir Impurity 10; GS 1278 Related Compound; (R)-PMPA Isopropyl Carbonate; Adenine, 9-[2-[[[[1-(methoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]-, (R)-; Tenofovir Intermediate
EINECS	Contact for details

Quality Control

Our Tenofovir Related Compound 10 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain optimal stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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.