Description

Tenofovir Alafenamide Impurity 34 is a high-purity reference standard critical for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Tenofovir Alafenamide. This compound serves as a key marker for identifying and quantifying process-related impurities during pharmaceutical development and manufacturing. It is an essential material for research scientists and quality assurance professionals in the pharmaceutical industry, particularly those involved in the production of antiviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods.
• Method Development and Validation: Crucial for developing and validating analytical procedures to monitor impurity profiles in Tenofovir Alafenamide API.
• Quality Control (QC) and Quality Assurance (QA): Used in routine batch release testing to ensure API purity meets pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance and Filing: Supports the identification and reporting of impurities in regulatory submissions (e.g., FDA, EMA) for drug approval.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Process Chemistry Research: Aids in optimizing synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Tenofovir Alafenamide Impurity 34
CAS No.	2126010-05-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	TAF Impurity 34; Tenofovir Alafenamide Related Compound 34; GS-7340 Impurity 34; (R)-9-(2-((Bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine Impurity; Tenofovir Alafenamide EP Impurity I; Tenofovir Alafenamide Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Alafenamide Impurity 34 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with the highest standards for reference materials. 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 or COA. Keep the container in a dry, cool, and well-ventilated place. 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 (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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