(Z)-9-Propenyladenine ((Z)-Mutagenic Impurity of Tenofovir Disoproxil)
97%
Reagent
Code: #106732
CAS Number
1464851-21-5
blur_circular Chemical Specifications
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Molecular Information
Weight
175.19 g/mol
Formula
C₈H₉N₅
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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.
format_list_bulleted Product Specification
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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(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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