(Z)-9-Propenyladenine ((Z)-Mutagenic Impurity of Tenofovir Disoproxil)
97%
- Product Code: 106732
CAS:
1464851-21-5
| Molecular Weight: | 175.19 g./mol | Molecular Formula: | C₈H₉N₅ |
|---|---|---|---|
| EC Number: | MDL Number: | ||
| Melting Point: | Boiling Point: | ||
| Density: | Storage Condition: | -20°C, airtight, dry |
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.
Product Specification:
| Test | Specification |
|---|---|
| Appearance | White To Off-White Solid |
| Purity (%) | 96.5-100 |
| Infrared Spectrum | Conforms To Structure |
| NMR | Conforms To Structure |
Sizes / Availability / Pricing:
| Size (g) | Availability | Price | Quantity |
|---|---|---|---|
| 0.005 | 10-20 days | ฿32,000.00 |
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| 0.010 | 10-20 days | ฿48,600.00 |
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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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