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Analytical Testing

Price: $199.00
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
  • Considerations When Determining a Routine Sample Size for a Retest Procedure
  • An Alternative to the ESD Approach for Determining Sample Size and Test for Out-of-Specification Situations
  • Use of the Bergum Method and MS Excel to Determine the Probability of Passing the USP Content Uniformity Test
  • The Square Root of N Plus One Sampling Rule: How Much Confidence Do We Have?
  • Stable Isotopic Characterization of Analgesic Drugs
  • Narrowing the Gap between Validation of Bioanalytical LC-MS-MS and the Analysis of Incurred Samples
  • An LC Method for the Separation and Determination of Ethynodiol Diacetate and Ethinyl Estradiol in Tablets
  • 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
  • Analysis via Differential, Frequency, and Cumulative Distribution Functions: A Particle-Size Distribution Example
  • Acceptable Analytical Practice for Dissolution Testing of Poorly Soluble Compounds
  • Microbial Testing in Support of Aseptic Processing
Stability
  • A Stress Testing Benchmarking Study
  • Identification of Out-of-Trend Stability Results
  • ICH Guidance in Practice Stress Degradation Studies on Metronidazole and Development of a Validated Stability-Indicating HPLC Assay Method
  • A Stability Program for the Distribution of Drug Products

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