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Review on stability indicating assay method or forced degradation study: strategy and regulatory consideration

By: Contributor(s): Publication details: Raipur Asian Pharma Press 2023Edition: Vol.13(2), Apr-JunDescription: 131-139pSubject(s): Online resources: In: Asian journal of pharmaceutical analysisSummary: Stability-indicating methods are crucial analytical techniques that aim to evaluate the stability of a drug substance or product over time. They are designed to detect any alterations in the drug's chemical, physical, or biological characteristics that may occur during storage, transportation, and usage. These modifications can significantly impact the drug's safety and effectiveness, making stability testing an integral part of pharmaceutical quality control. The stability-indicating methods are used to identify the degradation products of a drug, quantify the rate of degradation, and determine the factors that may contribute to degradation. These conditions can include exposure to light, heat, humidity, and various chemical and physical stressors. The methods can be chromatographic or spectrophotometric and undergo validation to ensure their reliability, accuracy, and specificity for the specific drug. The acceptable level of degradation in forced degradation studies should not exceed 5-30% of the total active ingredient present in the drug substance or product. This helps to ensure that the results obtained are trustworthy and can be used to make informed decisions about the stability of the drug.
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Articles Abstract Database Articles Abstract Database School of Pharmacy Archieval Section Not for loan 2023-1669
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Stability-indicating methods are crucial analytical techniques that aim to evaluate the stability of a drug substance or product over time. They are designed to detect any alterations in the drug's chemical, physical, or biological characteristics that may occur during storage, transportation, and usage. These modifications can significantly impact the drug's safety and effectiveness, making stability testing an integral part of pharmaceutical quality control. The stability-indicating methods are used to identify the degradation products of a drug, quantify the rate of degradation, and determine the factors that may contribute to degradation. These conditions can include exposure to light, heat, humidity, and various chemical and physical stressors. The methods can be chromatographic or spectrophotometric and undergo validation to ensure their reliability, accuracy, and specificity for the specific drug. The acceptable level of degradation in forced degradation studies should not exceed 5-30% of the total active ingredient present in the drug substance or product. This helps to ensure that the results obtained are trustworthy and can be used to make informed decisions about the stability of the drug.

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