Description

Tenofovir Impurity 1 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of Tenofovir, a key active pharmaceutical ingredient (API) in antiviral medications. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Tenofovir Impurity 1 in Tenofovir API and its drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor and control impurity profiles.
• Quality Control & Batch Release Testing: Ensures compliance with pharmacopeial monographs (e.g., USP, EP) and regulatory filing specifications for Tenofovir-based products.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various storage conditions over time.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop robust purification processes for Tenofovir.

Basic Information

Product Name	Tenofovir Impurity 1
CAS No.	2374212-01-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Related Compound 1; Tenofovir EP Impurity 1; Tenofovir USP Impurity 1; Tenofovir Process Impurity; (R)-9-(2-Phosphonomethoxypropyl)adenine Impurity; PMPA Impurity 1; GS-1278 Impurity
EINECS	Contact for details

Quality Control

Our Tenofovir Impurity 1 is manufactured and tested under strict quality systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity, ensuring it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

Specification

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