Description

Tenofovir Impurity 90 is a designated impurity standard used in the analytical profiling and quality control of Tenofovir, a critical antiretroviral medication. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure drug purity, safety, and regulatory compliance. It serves as a key reference material for method development, validation, and routine batch testing in the production of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) APIs and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating precise HPLC, UPLC, or LC-MS methods to quantify impurities in drug substances and products.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of drug products.
• Process Chemistry Research: Aids in identifying and controlling the impurity during the synthesis, purification, and scale-up of Tenofovir manufacturing processes.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP, BP) that specify limits for known and unknown impurities.

Basic Information

Product Name	Tenofovir Impurity 90
CAS No.	1015235-29-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Related Compound 90; TDF Impurity 90; TAF Impurity 90; Tenofovir EP Impurity G; Tenofovir Process Impurity; (R)-9-(2-Phosphonylmethoxypropyl)adenine Impurity; PMPA Impurity
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Impurity 90 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and identification.

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 place. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.