DOI: 10.7897/2230-8407.04517

ABSTRACT The Objective of the review article is to give a detailed description of the forced degradation studies as per the regulatory guidelines that are associated with various regulatory agencies. This article summarizes the collective views of industry practices on the topic of forced degradation studies. The article includes an overview of existing guidance's and literature for best practices.

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Available from: Kishore Kumar Hotha, Jun 29, 2015
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    ABSTRACT: Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop stabilityindicating methods that lead to quality stability data and to understand the degradation pathways of the drug substances and drug products. These experiments generally expose the material to an external stress to assess the stability of the constituents or formulation. External Stress mainly includes temperature, pH, light, moisture, and even exposure to other materials within the product formulation, and their degradation products. Conventionally, degradation tests can take very long periods of time, because standard test methods require the materials to be exposed to stress factors for periods of weeks or longer, and then tested using standard analytical methods. Accelerated testing is of clear benefit, as use of elevated temperature to increase the rate of interactions is the most powerful factor to shorten the length of time required for these tests. Forced degradation studies ensure appropriate stability of final pharmaceutical products in very early stages of pharmaceutical development.
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    ABSTRACT: There were several techniques determined for the analysis of citrate and citric acid mixtures in the pharmaceutical dosage forms. Titration methods, photometric and ion chromatographic methods were used for their determination. These methods will restrict too many factors where the accurate quantification of citrate and citric acid is extremely challenging. Citric acid is the natural flavor used as a preservative for many pharmaceutical applications. Deformulation techniques used for the manufacturing of generic drugs require authentic data for their regulatory submissions. Simple accurate and reproducible validated method developed for the determination of citric acid and sodium citrate by titration followed by HPLC analysis. Free citric acid was determined by the titration method and total citric acid was determined by HPLC analysis. After subtracting the free citric acid from total citric acid content, citric acid present in the sodium citrate content was determined. Sodium citrate content was determined by applying sodium correction factor to the subtracted value of the citric acid. The results met all the validation parameters and the method was successfully measured the amount of citric acid and sodium citrate in the marketed ophthalmic/oral solutions.
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    ABSTRACT: Excipients interactions with the drug product are the most predominant causes for a product failure. Regulated guidelines have stringent limits for the unknown impurities observed in the pharmaceutical dosage forms. The Quality of the excipients plays an important role in the finished product dosage forms which will form unknown impurities due to the impurities present in the excipients. Sometimes change in excipient manufacturer/lot gives not only the formulation related inconsistencies but hard-hitting encounters to analytical research due to their interactions with the drug product and formation of unknown impurities. Flavors used in the formulation process are the most possible origins to form impurities due to the trace level presence of aldehydes and ketones that were apparently used for its aroma. In this article identification, synthesis and characterization of unknown impurity formed in the famotidine oral solution due to Benzaldehyde which is present in the excipient of cherry flavor used in the formulation process. The samples of this impurity was investigated by HPLC, UPLC-MS/MS to generate the mechanism of the impurity formation. The Impurity was synthesized, separated and purified by Preparative HPLC and characterized by UV, MS/MS and NMR Results.
    Journal of Liquid Chromatography &amp Related Technologies 02/2015; DOI:10.1080/10826076.2014.999201 · 0.64 Impact Factor