Description

Tenofovir Impurity 117 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Tenofovir, a key active pharmaceutical ingredient (API) in antiviral medications. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Tenofovir Impurity 117 in drug substance and finished product analysis.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH guidelines.
• Quality Control (QC) & Quality Assurance (QA): Serves as a benchmark in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Tenofovir API.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and behavior of this specific impurity under various conditions.
• Research & Development (R&D): Used in synthetic chemistry R&D to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Tenofovir Impurity 117
CAS No.	1643116-22-6
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	Tenofovir Related Compound 117; 9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine; Tenofovir EP Impurity J; Tenofovir Impurity J; Tenofovir Process Impurity; Adenine, 9-[2-[[[[1-(1-methylethoxy)carbonyl]ethyl]amino]phenoxyphosphinyl]methoxy]propyl]-; (R)-PMPA Impurity
EINECS	Contact for details

Quality Control

Our Tenofovir Impurity 117 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized and released with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. Our quality commitment aligns with ICH Q3A, Q3B, and Q6A guidelines, supporting global regulatory compliance.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
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.