Description

Tenofovir Impurity 113 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of Tenofovir Disoproxil Fumarate (TDF) and related antiretroviral drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of HIV/AIDS and Hepatitis B treatments. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Tenofovir Impurity 113 in Tenofovir Disoproxil Fumarate (TDF) drug substance and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to monitor impurity levels and ensure drug product specifications are met according to ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability studies of TDF formulations.
• Regulatory Compliance & Filings: Supports regulatory documentation (e.g., ANDA, NDA) by providing a characterized impurity for identification and qualification reports.
• Research & Development: Utilized in R&D laboratories to study the degradation pathways and chemistry of Tenofovir and its related compounds.

Basic Information

Product Name	Tenofovir Impurity 113
CAS No.	1335287-28-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Related Compound 113; TDF Impurity 113; Tenofovir Disoproxil Impurity 113; (R)-9-(2-((Bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine Impurity; PMPA Impurity 113; GS-1278 Impurity; Viread Impurity 113
EINECS	Contact for details

Quality Control

Our Tenofovir Impurity 113 is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with the principles of cGMP and relevant ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a dry environment to prevent moisture uptake. 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)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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