Drug product analysis

Sample Preparation Perspectives in Drug Product Analysis... 

The recovery of a sample preparation must be assessed, because the recovery determines the accuracy of the analysis. For drug substance and drug product analysis, recovery of 100% is generally required to maintain required levels of accuracy and precision. For biological samples, less than quantitative recovery is generally acceptable if the recovery is reproducible. 

JE Polli. Analysis of in vitro - in vivo data. In GL Amidon, JR Robinson, RL Williams, eds. Scientific Foundations for Regulating Drug Products. Arlington, VA AAPS Press, 1997, pp 335-351. 

Most chemists tend to think of infrared (IR) spectroscopy as the only form of vibrational analysis for a molecular entity. In this framework, IR is typically used as an identification assay for various intermediates and final bulk drug products, and also as a quantitative technique for solution-phase studies. Full vibrational analysis of a molecule must also include Raman spectroscopy. Although IR and Raman spectroscopy are complementary techniques, widespread use of the Raman technique in pharmaceutical investigations has been limited. Before the advent of Fourier transform techniques and lasers, experimental difficulties limited the use of Raman spectroscopy. Over the last 20 years a renaissance of the Raman technique has been seen, however, due mainly to instrumentation development. 

It has now been established beyond any reasonable doubt that quality of a drug product cannot simply be ensured by inspection or analysis, but a control system has to be built into, from the very beginning of manufacture of a drug. Besides effective quality control measures exercised in every aspects of production including environment, screening of raw materials, process controls, intermediate shelf-life of finished products the most important aspect is to assess the bioavailability of the active principle. 

Orally Administered Drug Products Dissolution Data Analysis with a View to In Vitro-ln Vivo Correlation... 

Q + 5 +1.75(7, where standard deviation of drug release at the given time point. From this analysis, it is clear that, in addition to the average drug release, the homogeneity of drug product is of great relevance. 

The method for the evaluation of similarity of dissolution profiles depends on dissolution characteristic of the reference and test drug product. If both formulations (average value of n = 12 each) dissolve at least 85% of label claim within 15 min, dissolution profiles are generally assumed as similar and no further testing or data analysis is required. 

There are four different drug products under Part II chemical active substance(s), radiopharmaceutical products, biological medicinal products, and vegetable medicinal products. For example, the GMP production report for biological medicinal products includes description of the genes used, strain of cell line, cell bank system, fermentation and harvesting, purification, characterization, analytical method development, process validation, impurities, and batch analysis (GMP production of biopharmaceuticals is described in Chapter 10). A DMF (Exhibit 8.8) is submitted. 

Evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested, and held, and... 

SAMPLE PREPARATION FOR HPLC ANALYSIS OF DRUG PRODUCTS... 

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