Description

(Z)-Mutagenic Impurity Of Tenofovir Disoproxil CAS NO 1464851-21-5 is a specific stereoisomeric impurity associated with the active pharmaceutical ingredient Tenofovir Disoproxil. This compound is of critical importance in pharmaceutical development and quality control for ensuring drug safety and regulatory compliance. It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical and biotechnology sectors for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the (Z)-isomer impurity in Tenofovir Disoproxil Fumarate drug substance and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive and specific chromatographic methods (e.g., HPLC, UPLC) to monitor this mutagenic impurity per ICH M7 guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to ensure that Tenofovir Disoproxil-based drug products meet stringent specifications for genotoxic impurities.
• Stability Studies: Used to track the formation and levels of this impurity during forced degradation and long-term stability studies of pharmaceutical formulations.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate control strategies for potential mutagenic impurities.
• Research & Development: Utilized in pharmaceutical R&D to study the synthesis pathways, degradation profiles, and control measures for Tenofovir Disoproxil.

Basic Information

Product Name	(Z)-Mutagenic Impurity Of Tenofovir Disoproxil
CAS No.	1464851-21-5
Molecular Formula	C19H30N5O10P
Molecular Weight	519.45 g/mol
Synonyms	(Z)-Isomer of Tenofovir Disoproxil Impurity; Tenofovir Disoproxil (Z)-Isomer; (Z)-Tenofovir Disoproxil; Tenofovir Disoproxil Impurity Z; (Z)-9-((R)-2-((Bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine; (Z)-9-[2-[[Bis[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine; PMPA Bis(POC) (Z)-Isomer; GS 4331 Impurity Z
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality control conditions suitable for pharmaceutical analysis. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing the results for assay, related substances, and residual solvents, ensuring traceability and compliance with ICH Q3A, Q3B, and M7 guidelines.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% 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.