For centuries, the world has time and again come under the grip of epidemics which wipe out a major portion of civilization. And by the time scientific and medicinal fraternity can able to understand the gravity of the disease it becomes widespread.
The beginning of the year 2020 also started with the spread of novel CORONAVIRUS in Wuhan, China and the number of cases has been rising steadily. As of 13thFebruary 2020, Chinese health officials in the Hubei province reported 242 new deaths and 14,840 new cases of the flu-like virus. That brings the worldwide death toll to at least 1,357 and the number of confirmed cases to more than 60,000.
Scientists around the world are turning towards Artificial Intelligence (AI) to find a cure against this deadly virus as the other methods of vaccine development may take many years to develop.
The team of scientists used their pre-trained deep learning-based drug-target interaction model, Molecule Transformer-Drug Target Interaction (MT-DTI), to identify commercially available drugs that could act on viral proteins of 2019-nCoV.
The result showed that ATAZANAVIR, an antiretroviral medication used to treat and prevent the human immunodeficiency virus (HIV), is the most promising chemical compound. It was found that ATAZANAVIR showed the highest inhibitory potency on the viral proteinase.
Since Atazanavir and other top-ranked anti-viral drugs can be used for expanded experimental therapeutic options this may be one way to help the people being affected by the 2019-nCoV outbreak.
The above discussion proves the urgent need of Atazanavir in the pharmaceutical parlance. However, fetching a high purity and high-quality drug product is an uphill task for the pharmaceutical industries and it depends upon several factors.
Many impurities associated with Atazanavir which were formed during the drug development, drug research or commercialization steps. These impurities need to be examined for their specification limit, which affects the efficacy and quality of the final drug product.
Highly pure Reference standards serve as the basis of evaluation for both process and product performance and are the benchmarks for the assessment of drug potency for patient consumption.
List of Atazanavir impurities are cited in this article:
|S. No||Chemical Name||Product Name||Cas No.|
|1||Pyridinyl Benzoic Acid||Atazanavir Sulfate - Impurity A||4385-62-0|
|2||Pyridinyl Benzaldehyde||Atazanavir Sulfate - Impurity B||127406-56-8|
|3||Atazanavir R,S,S,S-diastereomer||Atazanavir Sulfate - Impurity F||1332981-14-2|
|4||AtazanavirBenzylidenehydrazine Carbamate||Atazanavir Sulfate - Impurity I||NA|
|5||Atazanavir S,S,S,R-Diastereomer Analog||Atazanavir Sulfate - Impurity G||1332981-16-4|
|6||Atazanavir S,R,R,S-Diastereomer||Atazanavir Sulfate - Impurity H||NA|
|7||AtazanavirBenzylidenehydrazine Analogue||Atazanavir Sulfate - Impurity D||NA|
|8||DealkylAtazanavir||Atazanavir Sulfate - Impurity C||1192224-24-0|
|9||N-(Methoxycarbonyl)-L-tert-Leucine||Atazanavir Sulfate - Impurity K||162537-11-3|
|10||Atazanavir Sulfate||Atazanavir Sulfate - API||229975-97-7|
|14||Pyridinyl Benzaldehyde Lactose Acetal||Pyridinyl Benzaldehyde Lactose Acetal||NA|
|15||8-epi Atazanavir||8-epi Atazanavir||1292296-09-3|
|16||2-[[4-(2-Pyridinyl)phenyl]methyl]hydrazinecarboxylic Acid 1,1-Dimethylethyl Ester||2-[[4-(2-Pyridinyl)phenyl]methyl]hydrazinecarboxylic Acid 1,1-Dimethylethyl Ester||198904-85-7|
|17||(R)-(5S,10S,11S,14S)-11-Benzyl-5,14-di-tert-butyl-3,6,13,16-tetraoxo-8-(4-(pyridin-2-yl)benzyl)-2,17-dioxa-4,7,8,12,15-pentaazaoctadecan-10-yl 2-((methoxycarbonyl)amino)-3,3-dimethylbutanoate||(R)-(5S,10S,11S,14S)-11-Benzyl-5,14-di-tert-butyl-3,6,13,16-tetraoxo-8-(4-(pyridin-2-yl)benzyl)-2,17-dioxa-4,7,8,12,15-pentaazaoctadecan-10-yl 2-((methoxycarbonyl)amino)-3,3-dimethylbutanoate||2131010-71-2|
|18||Methyl ((S)-1-(((2S,3S)-4-(((R)-4-(tert-butyl)-2,5-dioxoimidazolidin-1-yl)(4-(pyridin-2-yl)benzyl)amino)-3-hydroxy-1-phenylbutan-2-yl)amino)-3,3-dimethyl-1-oxobutan-2-yl)carbamate||Methyl ((S)-1-(((2S,3S)-4-(((R)-4-(tert-butyl)-2,5-dioxoimidazolidin-1-yl)(4-(pyridin-2-yl)benzyl)amino)-3-hydroxy-1-phenylbutan-2-yl)amino)-3,3-dimethyl-1-oxobutan-2-yl)carbamate||NA|
|19||Methyl ((S)-1-(2-((2S,3S)-3-((R)-4-(tert-butyl)-2,5-dioxoimidazolidin-1-yl)-2-hydroxy-4-phenylbutyl)-2-(4-(pyridin-2-yl)benzyl)hydrazinyl)-3,3-dimethyl-1-oxobutan-2-yl)carbamate||Methyl ((S)-1-(2-((2S,3S)-3-((R)-4-(tert-butyl)-2,5-dioxoimidazolidin-1-yl)-2-hydroxy-4-phenylbutyl)-2-(4-(pyridin-2-yl)benzyl)hydrazinyl)-3,3-dimethyl-1-oxobutan-2-yl)carbamate||1292296-13-9|
|20||Dimethyl ((3R,6R,7R,15S,16S,19S)-6,16-dibenzyl-7,15-dihydroxy-2,2,20,20-tetramethyl-4,11,18-trioxo-9,13-bis(4-(pyridin-2-yl)benzyl)-5,9,10,12,13,17-hexaazahenicosane-3,19-diyl)dicarbamate||Dimethyl ((3R,6R,7R,15S,16S,19S)-6,16-dibenzyl-7,15-dihydroxy-2,2,20,20-tetramethyl-4,11,18-trioxo-9,13-bis(4-(pyridin-2-yl)benzyl)-5,9,10,12,13,17-hexaazahenicosane-3,19-diyl)dicarbamate||NA|
There is a massive requirement of reliable Pharmaceutical reference standard sources to qualify and quantify these impurities in the final product of Atazanavir.
Reference materials are an integral component of the procedures of the private or public control specification and also a strict requirement of regulatory agencies.
The reliable Reference standard provider, provides Pharmaceutical standards, impurities, related substance, and stable isotopes along with a comprehensive Certificate of Analysis detailing the characterization process for the material, and ensuring its suitability for both qualitative and quantitative analysis.
The Certificate of Analysis must also take care of all the regulatory requirements.
At Pharmaffiliates, a dedicated analytical, synthesis and customer service teams go hand in hand to utilize the state-of-art infrastructure and high-end instruments with 21CFR part 11 compliance, to obtain par excellence reference standards.
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