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Impurities in pharmaceutical substances

  • Impurities in pharmaceutical substances are unwanted chemicals or compounds that can affect the drug's quality, safety, and efficacy.

  • They can originate from various sources and are classified as organic, inorganic, or residual solvents.

Illustration showing Impurities in pharmaceutical substances
Illustration showing Impurities in pharmaceutical substances

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Sources of Impurities:

Types of Impurities

1. Starting materials and reagents:

  • Impurities from raw materials, side reactions, or degradation products during drug synthesis.

2. Manufacturing process:

  • Introduced through incomplete reactions, by-products, or equipment contamination (e.g., metal ions or particulate matter).

3. Storage and transportation:

  • Exposure to heat, light, moisture, or oxygen during storage and transportation can lead to the degradation of the drug substance and the formation of impurities.

4. Packaging materials:

  • Chemicals from packaging (e.g., plasticizers, adhesives) can leach into the drug product.

5. Environmental contamination:

  • Contaminants like dust, microbes, or airborne chemicals may enter during manufacturing or storage.

Types of impurities:

Types of Impurities

1. Organic impurities:

  • Derived from the drug substance or synthesis process, including starting materials, by-products, and degradation products.

2. Inorganic impurities:

  • Mainly from manufacturing or environmental sources, such as metal ions or salts. These can also be residual reagents or catalysts.

3. Residual solvents:

  • Solvents used during synthesis may remain in the final product. Classified based on their toxicity and health risks.

4. Microbial contaminants:

  • Microorganisms (bacteria, fungi, viruses) that may contaminate the product during manufacturing or storage, compromising quality and safety.

Effects of impurities:

1. Safety concerns:

  • Some impurities may be toxic, cause allergic reactions, or result in drug interactions.

2. Reduced efficacy:

  • Impurities may interfere with the drug's action, reducing its therapeutic effectiveness.

3. Quality issues:

  • Impurities can alter physical and chemical properties (e.g., stability, color, odor), affecting product quality.

4. Regulatory compliance:

  • Impurities may lead to non-compliance with regulatory guidelines, causing drug batch rejections or recalls.

Regulatory Oversight:

  • Regulatory bodies like the FDA and EMA set strict guidelines for impurity limits in pharmaceuticals.

  • Companies must develop analytical methods to detect and control impurities, ensuring product safety and efficacy throughout the development and manufacturing process.


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