In making medicines, setting impurity limits for the Active Pharmaceutical Ingredient (API) is a key step to ensure quality and patient safety.
Impurities can come from raw materials, manufacturing steps, or even from storage over time.
By setting clear impurity specifications, we make sure that every batch of API meets the required quality standards and performs as expected.
While defining these limits, it’s important to know what types of impurities are present, how they are formed, and what their impact could be.
Guidelines like ICH Q3A(R2) and Q3C help in deciding safe and acceptable limits.
In simple terms, impurity specification shows how well we understand our product and process.
It reflects our dedication to making safe, effective, and reliable medicines.
Quality begins with the API and controlling impurities is the first step.
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Resource Person: Vijay Agrawal