Description

Tenofovirdisoproxil Impurity C is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Tenofovir Disoproxil. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Tenofovir Disoproxil Impurity C in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light) during drug product shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Tenofovir Disoproxil to minimize the formation of this impurity.

Basic Information

Product Name	Tenofovirdisoproxil Impurity C
CAS No.	1878175-82-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Disoproxil Related Compound C; Tenofovir Impurity C; Tenofovir Disoproxil Fumarate Impurity C; (R)-9-(2-((Bis((isopropoxycarbonyl)oxy)phosphinyl)methoxy)propyl)adenine; Isopropyl ((((1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phosphoryl)bis(oxy)bis(methylene) dicarbonate; Bis(POC) Tenofovir Impurity C
EINECS	Contact for details

Quality Control

Our Tenofovir Disoproxil Impurity C is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and structural confirmation (e.g., by NMR and MS), to ensure identity, potency, and traceability. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results. Our quality commitment aligns with the standards required for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with individual and total impurity limits
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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