(Z)-9-Propenyladenine ((Z)-Mutagenic Impurity of Tenofovir Disoproxil)

97%

Reagent Code: #106732
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CAS Number 1464851-21-5

blur_circular Chemical Specifications

scatter_plot Molecular Information
Weight 175.19 g/mol
Formula C₈H₉N₅
inventory_2 Storage & Handling
Storage -20°C, airtight, dry

description Product Description

(Z)-9-Propenyladenine is primarily recognized as a mutagenic impurity in the synthesis of Tenofovir Disoproxil, an antiretroviral medication used to treat HIV and hepatitis B. Its significance lies in its potential to cause genetic mutations, making it a critical focus in pharmaceutical quality control. During the manufacturing process, strict monitoring and control of this impurity are essential to ensure the safety and efficacy of the final drug product. Regulatory guidelines, such as those from the ICH (International Council for Harmonisation), mandate the identification, quantification, and limitation of such impurities to acceptable levels. Analytical methods, including HPLC and mass spectrometry, are employed to detect and quantify (Z)-9-Propenyladenine in drug substances and products. Its presence underscores the importance of robust purification processes and thorough risk assessment in drug development to minimize patient exposure to harmful impurities.

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Test Parameter Specification
Appearance White To Off-White Solid
Purity (%) 96.5-100
Infrared Spectrum Conforms To Structure
NMR Conforms To Structure

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Size Availability Unit Price Quantity
inventory 5mg
10-20 days Ft327,471.58
inventory 10mg
10-20 days Ft497,347.47
inventory bulk
10-20 days Ft0.00
(Z)-9-Propenyladenine ((Z)-Mutagenic Impurity of Tenofovir Disoproxil)
(Z)-9-Propenyladenine is primarily recognized as a mutagenic impurity in the synthesis of Tenofovir Disoproxil, an antiretroviral medication used to treat HIV and hepatitis B. Its significance lies in its potential to cause genetic mutations, making it a critical focus in pharmaceutical quality control. During the manufacturing process, strict monitoring and control of this impurity are essential to ensure the safety and efficacy of the final drug product. Regulatory guidelines, such as those from the ICH (International Council for Harmonisation), mandate the identification, quantification, and limitation of such impurities to acceptable levels. Analytical methods, including HPLC and mass spectrometry, are employed to detect and quantify (Z)-9-Propenyladenine in drug substances and products. Its presence underscores the importance of robust purification processes and thorough risk assessment in drug development to minimize patient exposure to harmful impurities.
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