Description

Tenofovir Impurity 31 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Tenofovir, a key antiviral medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Tenofovir and its drug products (e.g., Tenofovir Disoproxil Fumarate).
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity profiles and specifications for drug master files.
• Stability Studies: Employed in forced degradation and long-term stability studies of Tenofovir to understand degradation pathways and establish shelf-life.
• Research & Development: Used in pharmaceutical R&D for studying the metabolism, synthesis pathways, and impurity formation mechanisms of Tenofovir.

Basic Information

Product Name	Tenofovir Impurity 31
CAS No.	1797918-05-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Related Compound 31; Tenofovir EP Impurity 31; Tenofovir USP Impurity 31; Tenofovir Process Impurity; Tenofovir Degradant; (R)-9-(2-Phosphonylmethoxypropyl)adenine Impurity 31; PMPA Impurity 31
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Impurity 31 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards (USP, EP, ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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