Description

Tenofovir Impurity 21 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of Tenofovir-based active pharmaceutical ingredients (APIs) and finished drug products. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams involved in the development and manufacturing of antiviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control testing of Tenofovir and its formulations.
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for the accurate identification and quantification of impurities.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed as a marker to monitor impurity profiles in Tenofovir API and drug products under various stability conditions.
• Process Chemistry & Optimization: Helps in identifying and controlling the formation of this specific impurity during the API synthesis and purification processes.
• Pharmacopoeial Testing: Used to verify compliance with relevant pharmacopoeial monographs (e.g., USP, EP, BP) that specify impurity limits.

Basic Information

Product Name	Tenofovir Impurity 21
CAS No.	2053423-98-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Related Compound 21; Tenofovir EP Impurity 21; Tenofovir USP Impurity 21; Tenofovir Process Impurity 21; (R)-9-(2-Phosphonomethoxypropyl)adenine Impurity; PMPA Impurity 21; GS-1278 Impurity 21
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Impurity 21 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality standards are designed to meet the rigorous demands of pharmaceutical impurity analysis and regulatory compliance.

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. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.