Description

Tenofovir Impurity 96 is a high-purity reference standard used in the pharmaceutical development and quality control of Tenofovir-based antiviral medications. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities to ensure drug safety and regulatory compliance. It is an essential material for analytical laboratories, research institutions, and manufacturers engaged in the production of antiretroviral drugs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation in QC/QA laboratories.
• Impurity Profiling: Identification and quantification of this specific impurity in Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) active pharmaceutical ingredients (APIs) and finished dosage forms.
• Regulatory Compliance & Documentation: Supporting regulatory filings (e.g., ANDA, NDA) by providing impurity data for stability studies and specification setting.
• Process Chemistry Research: Used in research to understand the formation pathway of this impurity during API synthesis and to develop purification strategies.
• Stability Indicating Method: Serves as a marker in HPLC/UPLC methods to assess the stability of Tenofovir drug substances and products under various stress conditions.
• Pharmacopoeial Testing: Potential use in testing to meet the requirements of pharmacopoeial monographs (e.g., USP, EP) for Tenofovir-related compounds.

Basic Information

Product Name	Tenofovir Impurity 96
CAS No.	33921-08-3
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	Tenofovir Related Compound 96; 9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine; PMPA Impurity; GS-1278 Impurity; (R)-9-(2-Phosphonomethoxypropyl)adenine Impurity; Tenofovir EP Impurity G; Tenofovir Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Impurity 96 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for use as a reference standard. 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 at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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