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Process of Finding Impurities in Pharmaceutical Products

Article describes the procedure to find the impurities in pharmaceutical substances and products according to the ICH guidelines for stability testing.
The primary goal of any synthetic process is to create completely pure products, though in reality the marginal amount of impurity always has been found to be present in the final product after the complete chemical synthesis and manufacturing process. The presence of the impurities can enhance the level of toxicity and that is why an impurity analysis process has been carried out.

Understanding the nature of these impurities is important. The goal of the analysis is to check whether these impurities may bring possible hazards or not. There are some known and unknown impurities in pharmaceutical analysis.

Impurities in Pharmaceutical DrugsThe intention of pharmaceutical analysis should be to omit these impurities completely; if not then their intensity should be taken down to a controllable level so that no possible hazards can take place.

Overview of Workflow in Pharmaceutical Impurity Analysis:
Impurity in the pharmaceutical products has been often found as a minor component. The challenge for the analyzers is to determine the quantity of the impurities. Once the quantity has been identified, it can be ascertained that whether the impurity will increase the toxicity or not. After identifying the impurity and finding its quantity, the next big move for the analyzers is to structure the impurity.

These processes have to be carried out with high-end precision and with cutting-edge technologies so that accurate analysis results can be attained. In case of inaccurate analysis, possible hazards are the biggest threats to the pharmaceutical industry. ICH Q3A(R2) and Q3B(R2) describes the impurities in new drug substances and impurities in new drug products respectively.

Preparing Samples:
Preparing samples of the products is an important phase of impurity analysis process. For detection as well as degradation of the impurities in a final pharmaceutical product requires a sample preparation process. 

At this phase, it has to be kept in mind that the finished product or its ingredients are not the matters for carrying out analysis. The test or analysis process has been carried out to find out the minor impurities and degradants. Increase in the impurity during the stability testing is studied and any significant change is marked and investigated.

On the other hand, degradation study is a vast process and during this process, some of the common tests have been carried out. The product may undergo the process like elevated temperature tests, ultraviolet light tests, pH level test, humidity tests, etc. These tests are carried out to understand the physical properties or molecular structures of the potential impurities.

Mass Spectrometry Workflow Analysis:
Impurities are often found in the products in very low quantity, which can be typically like 0.1%. This level of detection requires special technological interventions. Chromatographic separation is the process for detecting such low presence of the impurities. For carrying out this process, mass spectrometers are required. These devices allow the detection as well as the acquisition of the fragmented data of these minor impure components.

Data Analysis Process:
After finding the presence of known and unknown impurities in pharmaceutical analysis, data analysis process has been carried out. The main objective of this process is to analyze the received data from the tests that have been carried out. 

Through meticulous data analysis, the final verdict on the product has been given. The job of the data analysts is to find whether the impurity is subtle or it is highly intense as well as alarming.

Also see: Forced Degradation Study in Pharmaceutical Stability

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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