Description

Tenofovir Impurity 37 is a designated impurity standard used in the analytical profiling of the active pharmaceutical ingredient (API) Tenofovir. This compound is critical for ensuring the quality, safety, and regulatory compliance of antiviral drug products. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tenofovir Impurity 37 in Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) API batches.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles during drug substance and drug product stability studies.
• Quality Control & Release Testing: Employed in routine QC laboratories to confirm that impurity levels in commercial API batches are within International Council for Harmonisation (ICH) and pharmacopeial (USP, EP) specified limits.
• Regulatory Submissions: Supports the preparation of regulatory filings (e.g., DMF, CMC sections) by providing characterized impurity data required by agencies like the FDA and EMA.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Tenofovir synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Tenofovir Impurity 37
CAS No.	161760-03-8
Molecular Formula	C9H14N5O4P
Molecular Weight	287.21 g/mol
Synonyms	9-[(R)-2-[[(S)-[[(S)-1-(Isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine; PMPA Impurity; GS 4331 Impurity; Tenofovir Related Compound 37; (R)-9-[2-(Phosphonomethoxy)propyl]adenine Isopropyl Ester Impurity; Adefovir Dipivoxil Impurity; Bis(POC)PMPA Related Substance
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Impurity 37 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive characterization using advanced spectroscopic and chromatographic techniques (including NMR, MS, and HPLC) to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, reporting batch-specific results for purity, related substances, and residual solvents. Our quality standards align with ICH guidelines and support cGMP compliance for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); 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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.