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Analytical Testing
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Item Number: PANZ100
Pharmaceutical Technology presents it's Analytical Testing Resource Guide. We've compiled 90 pages of the best Analytical Testing articles from the leading publication in pharmaceutical manufacturing and organized them in a single, easy-to-use volume.
Contents Include:
General
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Considerations When Determining a Routine Sample Size for a Retest Procedure
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An Alternative to the ESD Approach for Determining Sample Size and Test for Out-of-Specification Situations
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Use of the Bergum Method and MS Excel to Determine the Probability of Passing the USP Content Uniformity Test
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The Square Root of N Plus One Sampling Rule: How Much Confidence Do We Have?
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Stable Isotopic Characterization of Analgesic Drugs
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Narrowing the Gap between Validation of Bioanalytical LC-MS-MS and the Analysis of Incurred Samples
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An LC Method for the Separation and Determination of Ethynodiol Diacetate and Ethinyl Estradiol in Tablets
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Photosensitiviy of Internal Standard Valerophenone Used in USP Ibuprofen Bulk Drug and Tablet Assay and Its Effect on the Quantitation of Ibuprofen and Its Impurities
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Analysis via Differential, Frequency, and Cumulative Distribution Functions: A Particle-Size Distribution Example
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Acceptable Analytical Practice for Dissolution Testing of Poorly Soluble Compounds
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Microbial Testing in Support of Aseptic Processing
Stability
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A Stress Testing Benchmarking Study
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Identification of Out-of-Trend Stability Results
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ICH Guidance in Practice Stress Degradation Studies on Metronidazole and Development of a Validated Stability-Indicating HPLC Assay Method
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A Stability Program for the Distribution of Drug Products
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