Description

Tenofovir Impurity 98 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 (API) 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 reference material (CRM) for the identification and quantification of impurities in Tenofovir API and its drug products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine batch release testing to ensure compliance with pharmacopeial specifications (USP, EP, ICH).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of drug formulations.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, synthesis, and toxicological profile of Tenofovir-related compounds.

Basic Information

Product Name	Tenofovir Impurity 98
CAS No.	121149-98-2
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	Tenofovir Related Compound 98; (R)-9-(2-Phosphonomethoxypropyl)adenine Impurity 98; PMPA Impurity 98; GS 1278 Impurity; (R)-PMPA Impurity 98; 9-[(R)-2-(Phosphonomethoxy)propyl]adenine Impurity; Tenofovir EP Impurity H
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Impurity 98 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial and ICH guidelines. 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) in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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