Description

Tenofovir Impurity 52 is a designated impurity standard used in the analytical profiling and quality control of Tenofovir, a critical active pharmaceutical ingredient (API). This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and regulatory compliance of antiviral drug products. It serves as a key reference material for method development, validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Tenofovir API and its formulations.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or LC-MS methods to separate and quantify impurities.
• Regulatory Compliance & Filing: Supports the identification and characterization of impurities for regulatory submissions (e.g., FDA, EMA) as per ICH Q3A/B guidelines.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of drug substances and products.
• Research & Development: Employed in synthetic chemistry R&D to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.
• Pharmacopoeial Testing: Applicable for testing against monographs in pharmacopoeias such as USP, EP, or BP where control of related substances is required.

Basic Information

Product Name	Tenofovir Impurity 52
CAS No.	146297-30-5
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	Tenofovir Related Compound 52; Tenofovir EP Impurity G; Tenofovir USP Impurity; 9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine; PMPA Impurity; (R)-PMPA Impurity; GS-1278 Impurity; Adefovir Dipivoxil Impurity (related)
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Impurity 52 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopoeial and customer-specific standards. 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 in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.