R&D Stability Chemist – Research Paper
R&D stability chemists are an integral part in the process of creating pharmaceutical drugs (these can include tablets, capsules, gels, suspensions, liquids, sprays, and creams). They are part of the pharmaceutical industry, which employs hundreds of thousands of chemists worldwide. Typical R&D chemists need at least 2 years of pharmaceutical experience, and at least a Bachelor of Science degree in chemistry, pharmaceutical science, or a related field. Creating any type of pharmaceutical drug requires highly specialized research and development teams, consisting of many different types of chemists.
R&D stability chemists test drugs for their stability over long periods of time, and report their findings to the Food and Drug Administration (FDA). For example, a stability chemist might need to test whether a drug’s potency is between 75 to 102%, as well as whether it is chemically stable and does not degrade too much over long periods of time. Stability chemists create specifications for the drug, and after the testing period (typically 3 to 4 years), the drug is compared with these specifications in order to determine its quality and its stability.
To ensure that data is accurate, tests are undertaken in at least 3 batches (testing rules set out by the FDA). One batch can range from 50 kg and 100 kg of pharmaceutical drugs. The batches of drugs are stored in large rooms called stability chambers, which are temperature and humidity-controlled, in order to see which environments the drugs can handle (storing at room temperature, in refrigerators, etc.). Another set of batches are also tested against a variety of temperature and humidity settings in separate stability chambers, to test for impurities in extreme changes. Tests are also made at least 2 years past the drug’s specified expiry date. In some situations, several batches of drugs needed to be tested 3 or more times, resulting in 5 or more...