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Where do impurities arise? Well, impurities can be found in the drug substance. The drug substance is the active pharmaceutical ingredient or API. The drug substance is often an organic molecule of some complexity, and its synthesis may include impurities. Depending on the amount of any single impurity, the impurity may need to be reported, chemically identified, or qualified through toxicology testing. Impurities can also originate in the drug product, which includes not only the drug substance but also excipients, like the various binders, dyes, fillers, and solvents, used to create the formulated drug that will be used by patients. All these other components can also potentially contain impurities. Furthermore, storage of the drug product can also lead to degradation of either the drug substance or excipients. The formation of unexpected impurities in a drug product can lead to safety concerns and even product recalls. Let’s see a few examples of recent drug recalls.
Here are some recent reports of impurities and recalls. I say recent. These are recent at the time of the recording of this video. A more up-to-date list can be found through the link at the bottom of the screen. What kind of impurities required a product recall. The top example involves an oral rinse with microbial contamination. The second example is related, with an eye drop product having fungal contamination. Products like these are typically sterile, but if the sterilization process is not complete, you can observe contamination of an entire lot of product. Fungal and microbial contaminants are especially likely in aqueous solutions such as eye drops. Next we have an oral anticoagulant. This is an oral pill. A chemical impurity was found in this product and required a recall. While I am not completely certain, I believe that the impurity is from the synthesis of the drug substance, the API, and not from the formulation. The last example involves glass particles. Glass is actually a common impurity. You can imagine that many drugs are packaged in glass containers - vials and ampules. These products are filled with high-speed machinery. If one vial breaks, you can potentially contaminate an entire batch with bits of glass that are moving through the machinery. So, this list, although short, gives a glimpse into some of the ways impurities can pose a safety risk and trigger a product recall.
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