Description

Tenofovir Impurity 38 is a designated impurity standard used in the analytical profiling of the active pharmaceutical ingredient (API) Tenofovir. This compound is critical for pharmaceutical manufacturers and quality control laboratories to ensure the purity, safety, and efficacy of Tenofovir-based drug products. It serves as a key reference material for method development, validation, and routine batch testing in the production of antiviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Tenofovir Impurity 38 in Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) API batches.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and accurately measure this specific impurity.
• Quality Control & Release Testing: Used in routine QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial limits (USP, EP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data and specifications for drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of this impurity over time under various stress conditions, ensuring drug product shelf-life.
• Research & Development: Used in R&D settings to study the degradation pathways and chemistry of Tenofovir, aiding in process improvement and formulation science.

Basic Information

Product Name	Tenofovir Impurity 38
CAS No.	161760-09-4
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethoxy]phenoxyphosphinyl]methoxy]propyl]adenine; Tenofovir Isopropyl Carbonate Ester Impurity; PMPA Isopropyl Carbonate Impurity; Tenofovir Related Compound 38; (R)-9-(2-Phosphonomethoxypropyl)adenine Isopropyl Carbonate Derivative; Adefovir Dipivoxil Process Impurity; GS 1278 Related Substance
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Impurity 38 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results against established specifications. Our quality standards align with the requirements for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.