Description

Tenofovir Impurity 64 is a designated impurity associated with the active pharmaceutical ingredient Tenofovir, an antiviral medication. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories to ensure the purity, safety, and efficacy of Tenofovir-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tenofovir drug substance and finished products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions and during shelf-life studies.
• Process Chemistry Research: Aids in understanding and optimizing the Tenofovir synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Tenofovir Impurity 64
CAS No.	1878175-76-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Related Compound 64; Tenofovir EP Impurity 64; Tenofovir USP Impurity 64; Tenofovir Process Impurity; (R)-9-(2-Phosphonomethoxypropyl)adenine Impurity; PMPA Impurity; GS-1278 Impurity; Viread Impurity
EINECS	Contact for details

Quality Control

Our Tenofovir Impurity 64 is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic techniques, to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data on purity, impurities, and residual solvents, ensuring compliance with pharmacopeial standards (USP/EP/ICH).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). For long-term storage, consider storing desiccated at 2-8°C. Handle and store in accordance with good laboratory practices.

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

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