Alike the advancement of the world of technology, the medical studies too is having an extended vastness in this field. In fact, any improvement is never possible unless the world demands it. With the passing days, it is the humans who themselves demand it. The increase in types of diseases and the increase in the total population suffering from have led to growth in the demand. Thus, to some degree, the situation or the circumstances, necessitates the scientist to increase their study field.
On this note, the key factor of medication to humans, i.e. medicines need that upsurge in its production. The world supplies with ample categories of drugs daily for personal convenience. However, are you aware of the fact all these medication procedures have some impurities in them? Well, now millions of questions may creep inside you about the impurities.
More inquisitiveness on this aspect
When human brains start accumulating inquisitive facts, it often becomes necessary to clarify all these facts. Similarly, it became a curious issue to know about how are impurities used in the different pharmaceutical procedures and what are the reasons they are used for? Well, to develop clarity of this note, the topic needs an extensive discussion.
Initiating from the fact that what are impurities? Well, as the name suggest, it is something that is not in a pure state and can be harmful, in whichever aspect used. Medically, it has been indicated that all active pharmaceutical impurities have a certain percentage of impurities in them. This primarily can be harmful and therefore they need treatment, if it cannot be exterminated.
Knowing the treatments of the impurities
After being acquainted with the basic knowledge, you may be inquisitive to learn about the treatments. Drugs like Rasagiline used mainly for Parkinson’s disease was invented to save a lot of people from this particular illness. But the presence of Rasageline Impurities in it could increase the side effects of the medication. Thus, the necessitated treatment to the impurity is required for ensuring the user of the medication about its safety.
Not only is it expected to be treated. But the scientists also need to assure people about the certain percentage of its use. The impurities found in one component are not particularly a unit. The number may be many. Hence, different impurities may have different rates of its usage. This percentage depends specifically on the isolation of the impurity.
Categorizing the impurities
The process of separation may be many, but before that, it is important to identify the formulated impurities from one component. For example, the Rasagiline component has some Rasageline Impurities in the process. They are Rasagiline 1 Aminiondane impurity, rasagiline 1 Indanol Impurity, Indanone Impurity,Rasagiline2 ChloroAllyl Impurity, Rasagiline 3 Amino 1H Indanone Impurity, BromoIndanone Impurity, RasagilineAllyl Impurity, Impurity B, KetoImpurity, Oxindole Impurity, etc.
Hence, when you have such a huge number of formulations from one particular component, it indicates that there is some requirement on its formulation. However, all these formulations have rigorous standards of use. Not all can be utilized in a similar standard. The difference in standard is also because of the difference in the standards is also because of the molecular criteria.
As per the ICH guidelines
Apart from the molecular details, the impurities are identified under a particular chemical name. The ICH guidelines help in laying the importance to these impurities. The percentage of usage is determined and thereby that portion helps in using them. The different processes used are also generally guided by the ICH or the International Conference on Harmonization. Though the methods of identifying or categorizing them are many, the ICH helps in providing guidelines for using one.
Some of them are like, Gravimetric analysis, Electron paramagnetic resonance, liquid–liquid extraction method, gas–liquid chromatography, solid-phase extraction methods, Capillary electrophoresis, Spectrometry- Ultraviolet and Infrared Spectrometry, Spectroscopy- RAMAN and Nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry.
Concluding important factors
The concluding aspect of all factors is the isolation of the impurities. If the pharmaceutical companies avoid the process of isolating the impurities from the active pharmaceutical ingredients, the entire composition of the drug formula can change. In fact, this can also lead to the modification of the side effects of the medicines. For example, like Rasagiline has itself a side effect of hypertension or hypotension. The increased percentage of Rasageline can change the reactions. Hence, it is always emphasized on the pharmaceutical companies to go through the special process of isolation.