Description

Tenofovir Disoproxil Related Compound B (10 Mg) ((E)-9-(Prop-1-Enyl)-9H-Purin-6-Amine) is a high-purity reference standard and impurity used in the pharmaceutical development and quality control of antiviral medications. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by providing a benchmark for impurity identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of Tenofovir Disoproxil Fumarate and related antiviral therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of impurities in Tenofovir Disoproxil Fumarate API batches.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for quality control protocols.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling.
• Stability Studies: Employed to monitor the formation of degradation products in drug substance and drug product stability programs under ICH guidelines.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this specific impurity.
• Quality Assurance/Quality Control (QA/QC): A critical tool for in-process testing and final release testing of antiviral drug substances to ensure they meet pharmacopeial specifications.

Basic Information

Product Name	Tenofovir Disoproxil Related Compound B (10 Mg) ((E)-9-(Prop-1-Enyl)-9H-Purin-6-Amine)
CAS No.	4121-40-8
Molecular Formula	C8H9N5
Molecular Weight	175.19 g/mol
Synonyms	(E)-9-(Prop-1-enyl)-9H-purin-6-amine; 9-[(1E)-1-Propen-1-yl]-9H-purin-6-amine; Tenofovir Impurity B; Tenofovir Disoproxil Impurity B; GS 4331 Impurity; PMPA Impurity; (E)-Isomer of 9-(1-Propenyl)adenine; Ade1pr
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Disoproxil Related Compound B is manufactured and analyzed under strict quality management systems. The product is characterized using advanced spectroscopic and chromatographic techniques to ensure high purity and structural identity. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing purity, chromatographic data, and spectroscopic confirmation. Our quality protocols are designed to support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines for impurities in new drug substances and products.

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. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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