Description

Tenofovir Related Compound 1 is a high-purity chemical reference standard, essential for pharmaceutical research and development. This compound serves as a critical impurity marker and analytical standard in the quality control of Tenofovir-based active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material for the identification and quantification of specific impurities in Tenofovir Disoproxil Fumarate and related drug substances.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies: Employed as a benchmark to monitor degradation pathways and establish shelf-life specifications for Tenofovir-containing formulations.
• Regulatory Compliance and Documentation: Essential for generating impurity data for regulatory submissions (e.g., to FDA, EMA) and for meeting ICH Q3A/B guidelines on impurities.
• Pharmaceutical Research: Utilized in metabolic and pharmacokinetic studies to understand the drug's behavior and related compound formation.
• Quality Assurance/Quality Control (QA/QC): A key component in routine batch release testing to ensure API and drug product purity meets specified limits.

Basic Information

Product Name	Tenofovir Related Compound 1
CAS No.	342631-41-8
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine; PMPA Impurity; Tenofovir Impurity; Tenofovir Related Substance 1; GS 4331 Impurity; (R)-PMPA Related Compound A; Adefovir Dipivoxil Related Compound; Bis(POC)PMPA Impurity
EINECS	Contact for details

Quality Control

Our Tenofovir Related Compound 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and control of specified impurities, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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