Description

Tenofovir Impurity 32 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Tenofovir-based active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification and quantification of this specific impurity in Tenofovir and its prodrugs (Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide).
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for accurate impurity detection.
• Quality Assurance/Quality Control (QA/QC): Essential for routine batch release testing of API and drug products to ensure they meet stringent pharmacopeial (USP, EP) and ICH guidelines.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry research to study degradation pathways and to develop improved purification processes for the main API.

Basic Information

Item	Detail
Product Name	Tenofovir Impurity 32
CAS No.	1796931-18-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Related Compound 32; Tenofovir Impurity O; Tenofovir EP Impurity G; Tenofovir Process Impurity; 9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine (Proposed); Tenofovir Degradant; Tenofovir Analog; Tenofovir Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Impurity 32 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with ICH Q3A/B, USP, and EP standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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