Sources of impurities in medicinal agents
There are various sources of impurities in medicinal agents, including:
- Manufacturing process: Impurities can be introduced during the manufacturing process, such as byproducts or residual solvents.
- Starting materials: Impurities may be present in the starting materials used to make the medicinal agent. For example, impurities can be introduced during the extraction or synthesis of active pharmaceutical ingredients (APIs) from natural sources or chemical synthesis.
- Storage conditions: Impurities can also be formed during the storage of the medicinal agent due to degradation or contamination. For example, if a medication is exposed to heat, light, moisture, or air, it may degrade and form impurities.
- Packaging materials: Impurities can also come from the packaging materials used for the medicinal agent, such as plastic or glass containers, and the closure systems used.
- Cross-contamination: Cross-contamination can occur during the manufacturing process or storage if the medicinal agent comes into contact with other substances or equipment that contain impurities.
It’s worth noting that the presence of impurities in medicinal agents can affect the safety and efficacy of the medication. Therefore, it’s important for manufacturers to conduct rigorous testing and quality control to minimize impurities and ensure the safety and efficacy of the medication.
First Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise
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