Description

Tenofovir Impurity 89 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 the active pharmaceutical ingredient (API) Tenofovir. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing. The use of well-characterized impurities like this is essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control of Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) APIs and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish retention times, identify impurity peaks, and calibrate systems.
• Stability Studies: Employed to monitor and quantify the formation of this specific impurity in drug substances and products under various stress conditions.
• Regulatory Compliance & Filings: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity profiles and characterization data.
• Research & Development: Utilized in synthetic chemistry R&D to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.
• Pharmacopoeial Testing: Applied as a system suitability standard in tests mandated by USP, EP, or other pharmacopoeias for Tenofovir-based medications.

Basic Information

Product Name	Tenofovir Impurity 89
CAS No.	1015235-28-5
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	Tenofovir Related Compound 89; Tenofovir EP Impurity J; Tenofovir USP Impurity; 9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethoxy]phenoxyphosphinyl]methoxy]propyl]adenine isomer; PMPA Impurity; GS-1278 Impurity; Adefovir Impurity analog; Tenofovir Degradant
EINECS	Contact for details

Quality Control

Our Tenofovir Impurity 89 is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards align with ICH guidelines for impurities in new drug substances (Q3A(R2)) and support compliance with cGMP, USP, and EP requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.