Once upon a time, there lived a mighty elephant in a dense forest. This mighty elephant was not afraid of anyone, and nobody ever dared challenge him- until one day, a tiny ant did! The elephant laughed out loud, thinking that a tiny ant could never cause him any harm! He raised his left paw to crush the little ant, but before he could, the ant quickly crawled up his trunk and into his left ear, biting him hard. The very next moment, that giant creature cried out in pain. The mighty elephant, who was once an untouchable giant, had been brought to his knees by a mere ant!
Now, imagine Valsartan as the mighty elephant, and the ant as the trace impurity. The impurity, even in trace levels, has the potential to create havoc, like product recalls or compromise the patient’s safety. In this blog, we highlight the importance of using Valsartan Nitrile/Cyano Analog as a working standard to ensure and maintain the purity of your drug. Read further to find out how something small, like a tiny ant, can make a huge difference.
What is the purpose of the Valsartan drug?
Valsartan is a type of Angiotensin II Receptor Blocker (ARB) drug which is used to treat high blood pressure, heart failure, and improve survival after myocardial infarction. It also helps to prevent strokes and kidney problems as it relaxes blood vessels and enables a smoother blood flow. The drug, Valsartan, is one of the most widely prescribed ARBs and forms an integral part of the hypertension treatment protocols all over the world. Therefore, the purity of this drug must be strictly maintained and observed. However, just like every other synthetic drug in the pharma, to produce valsartan, several complex chemical reactions are involved. During these chemical reactions, sometimes the impurities are introduced into the product. Valsartan Nitrile/Cyano Analog is one of the most important impurities commonly found in valsartan formulation.
What is Valsartan Nitrile/Cyano Analog Impurity?
Valsartan Nitrile/Cyano Analog, is a by-product produced during the manufacturing process of the Valsartan drug. This by-product, though present in trace levels, is highly toxic in nature. Its chemical structure makes it carcinogenic, and therefore, its levels must be kept in check in the drug formulations.
Valsartan Nitrile/Cyano Analog, chemically known as N-Valeryl-N-[(2'-cyanobiphenyl-4-yl)methyl]-L-valine, must be carefully monitored and quantified, especially for the ANDA (Abbreviated New Drug Application) filing to the FDA and during commercial production. There are several significant applications of this impurity, which we will discuss below.
Here are some more details of this impurity:
Synonyms: N-((2'-Cyano-[1,1'-biphenyl]-4-yl)methyl)-N-pentanoyl-L-valine, (S)-2-(N-((2'-Cyanobiphenyl-4-yl)methyl)pentanamido)-3-methylbutanoic acid
Molecular Weight: 392.49g/mol
Product Code: 54628
Molecular formula: C24H28N2O3
Why should you monitor Cyano Analog levels?
With several incidents of Valsartan drug recalls due to the presence of nitrosamine and nitrile-related impurities, the concerns regarding the presence of such impurities, even in trace amounts, are increasing.
The global regulatory authorities, including the U.S. FDA, EMA, and CDSCO (India’s Central Drugs Standard Control Organization), now ask manufacturers to implement tight impurity profiling and control strategies as a part of their compliance frameworks. While submitting ANDA, the companies must also submit valid data on potential impurities such as Valsartan Cyano Analog. By monitoring and quantifying this impurity, you ensure patient safety by limiting the presence of toxic degradation products. It also helps maintain batch-to-batch consistency in generic drug manufacturing.
Applications of Valsartan Nitrile/Cyano Analog
In order to detect the presence of Nitrile/Cyano analog, the pharma companies use this impurity as a working standard while developing analytical methods, which include:
Development of sensitive HPLC and LC-MS methods for detecting trace levels of impurity.
To establish Limit of Detection (LOD) and Limit of Quantitation (LOQ) for method accuracy.
Conducting forced degradation studies for assessing the impurity's formation under several stress conditions such as heat, humidity, pH and more.
To develop such analytical methods, it is important to choose a well-characterized and highly pure sample of Valsartan Nitrile Analog for accurate quantification and to obtain correct calibration curves in the analytical assays.
Buy Valsartan Nitrile/Cyano Analog Online
At Advent, we understand the dire need to procure reliable pharmaceutical impurities and working standards. Our R&D team has made diligent efforts to develop and supply this impurity across the world. With years of experience in impurity synthesis, we have successfully synthesized this impurity at the milligram to gram scale. Our impurities are more than 95% pure, ensuring quality control for analytical and regulatory purposes. We provide this compound along with its comprehensive characterisation data, which includes:
¹H NMR (Proton Nuclear Magnetic Resonance): to confirm structure
Mass spectrometry: to verify molecular weight
Infrared Spectroscopy: to identify functional groups
TGA (Thermogravimetric Analysis): to assess thermal stability
This analytical profile allows its use as a working standard in pharma labs and companies in domestic as well as international markets.
Into the Future: The Role of Valsartan Nitrile/Cyano Analog
As the pharmaceutical sciences advance, the demand for precision in impurity detection also increases. The manufacturing companies must be able to accurately detect even the slightest traces of by-products and degradation compounds.
In such cases, the impurity standards like Valsartan Nitrile Analog are not just tiny ants, but form the utmost essential compounds in the pharma manufacturing companies. At Advent, we help you meet stringent standards by synthesising and characterising such compounds and ensuring supply chain consistency. We offer technical support along with regulatory documentation. To get more information on Valsartan Nitrile/Cyano Analog, and our other 3000 products, visit our website today!
