Description

Tenofovir Disoproxil Impurity B is a specified impurity of the active pharmaceutical ingredient Tenofovir Disoproxil Fumarate, a key antiviral medication. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control to ensure drug purity and safety. It is essential for analytical laboratories, quality assurance departments, and manufacturers in the global pharmaceutical industry who require high-purity chemical reference materials for compliance with stringent regulatory standards.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Tenofovir Disoproxil Fumarate drug substance and finished products.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC, GC) to meet ICH Q3A/B guidelines.
• Essential for pharmaceutical quality control (QC) and stability studies to monitor impurity profiles.
• Used in regulatory submissions to agencies like the FDA, EMA, and PMDA to demonstrate thorough impurity characterization.
• Supports research and development of generic antiviral formulations.
• Employed in pharmacopoeial testing to verify compliance with monographs from USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Tenofovir Disoproxil Impurity B
CAS No.	36817-69-3
Molecular Formula	C19H30N5O10P
Molecular Weight	519.45 g/mol
Synonyms	Tenofovir Impurity B; Tenofovir Disoproxil Related Compound B; 9-[(R)-2-[[Bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine; PMPA Bis(POC) Impurity B; (R)-PMPA Bis(POC) Impurity B; GS 4331 Impurity B; Bis(POC)PMPA Impurity B
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Disoproxil Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). Certificates of Analysis (COA) are available upon request, providing detailed batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.