Description

Tenofovir Impurity 95 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Tenofovir-based active pharmaceutical ingredients (APIs) and finished drug products. 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 material for the identification and quantification of specific impurities in Tenofovir API and its formulations.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Tenofovir drug substances and products under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Quality Control & Batch Release: Acts as a system suitability standard and for routine quality control testing to ensure batch-to-batch consistency.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Tenofovir.

Basic Information

Product Name	Tenofovir Impurity 95
CAS No.	1884329-63-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Related Compound 95; Tenofovir EP Impurity 95; Tenofovir USP Impurity 95; Tenofovir Degradation Product 95; (R)-9-(2-Phosphonomethoxypropyl)adenine Impurity 95; PMPA Impurity 95; GS 1278 Impurity 95; TDF Impurity 95
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Impurity 95 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. 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 in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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 unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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