Description

Tenofovir Impurity W is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Tenofovir and its related pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Tenofovir Impurity W in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine quality control testing to monitor and control impurity levels during the manufacturing process.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and behavior of this specific impurity under various conditions.
• Research & Development (R&D): Used in synthetic chemistry and pharmacology research to study the properties, formation pathways, and potential effects of this impurity.

Basic Information

Product Name	Tenofovir Impurity W
CAS No.	1244022-55-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Related Compound W; Tenofovir EP Impurity W; Tenofovir USP Impurity W; Tenofovir Process Impurity; (R)-9-(2-Phosphonomethoxypropyl)adenine Impurity; PMPA Impurity; GS-1278 Impurity; Viread Impurity
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Impurity W is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.