Effects of Impurities in Pharmaceuticals

Impurities may bring about incompatibility with other substances. Impurities may lower the shelf life of the substances. Impurities may cause difficulties during formulations and use of the substances. Sometimes Impurities change the physical and chemical properties of the substances. Impurities present in a solid organic compound tend to have 2 effects on the melting point. First, they tend to lower the overall melting point of the compound versus the value for pure material. Second, they tend to increase the range of the melting point values.

Effect of Impurities: We know that almost pure substances are difficult to get, and some amount of impurity is always present in the material. So, the impurities which are present in the substances may have the following effects.

• Impurities may bring about incompatibility with other substances.
• Impurities may lower the shelf life of the substances.
• Impurities may cause difficulties during formulations and use of the substances.
• Sometimes Impurities change the physical and chemical properties of the substances.
• The therapeutic effect can be decreased.
• Shows the toxic effect after a certain period.
• Injurious when present above certain limits.
• It may change the odor, color, the taste of the substance.

To prevent these impurities many tests such as limit tests are carried out to lower the impurities to make the pharmaceuticals safer.

Quality matters

Once a drug product has been manufactured it is possible that low levels of impurities will remain, but that is not an automatic indicator that a drug product’s quality is bad. The key concerns for manufacturers, regulators and patients, are the type and level of those impurities.

Regulatory agencies and standards-setting organizations like the U.S. Pharmacopeial Convention (USP) spend a great deal of time and effort establishing limits on allowable levels of impurities in medicines to help ensure that they do not pose a threat to public health and that product quality meets or exceeds the public’s expectations.

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