Degradation products are a type of impurity formed when a substance chemically breaks down over time due to factors like heat, light, or moisture. While all degradation products are impurities, not all impurities are degradation products—some arise from manufacturing, excipients, or environmental contamination. Degradation Vs Impurities: FAQs You May Like: Degradation Vs Impurities: Key Differences […]
Degradation products are a type of impurity formed when a substance chemically breaks down over time due to factors like heat, light, or moisture. While all degradation products are impurities, not all impurities are degradation products—some arise from manufacturing, excipients, or environmental contamination.
Degradation refers to the breakdown of a drug over time, often due to environmental factors. Impurities are unwanted chemicals that may be present in the drug due to synthesis, manufacturing, or degradation.
A degradation product is a compound resulting from the chemical breakdown of a drug over time.
Degradation products of drugs are substances formed when a drug loses its stability and breaks down, potentially affecting its safety and efficacy.
Process impurity is a contaminant introduced during drug synthesis or manufacturing.
Degradation impurity is a substance formed when the drug degrades over time.
Environmental factors like heat, light, moisture, pH changes, and oxygen can cause drug degradation.
They can affect the drug’s safety, efficacy, and shelf life, so they must be identified and controlled.
Using analytical techniques like HPLC, LC-MS, UV spectroscopy, and stability studies.
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| Aspect | Degradation Products | Pharmaceutical Impurities |
|---|---|---|
| Definition | Hydrolysis products, oxidation products, and photolytic byproducts. | Unwanted chemicals that remain with the drug substance or product during or after manufacturing. |
| Origin | Result from chemical changes during storage, exposure to heat, light, moisture, etc. | Originating from raw materials, the manufacturing process, or storage. |
| Formation Stage | Typically formed after manufacturing (during shelf life). | Present during or after manufacturing. |
| Examples | Hydrolysis products, oxidation products, photolytic byproducts. | Residual solvents, unreacted starting materials, by-products. |
| Control Requirement | Must be monitored throughout the shelf life. | It must be controlled during manufacturing and in the final product. |
| Impact on Drug | Can reduce potency and cause toxicity. | May affect drug safety, efficacy, and quality. |
| Regulatory Guidelines | Addressed in ICH Q3B (for degradation products). | Addressed in ICH Q3A (organic impurities) and Q3C (residual solvents). |
| Detectability | Often appear during stability testing. | Detected in quality control during or after production. |
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