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Purpose. This review describes a conceptual approach to the characterization of pharmaceutical solids. Methods. Four flow charts are presented: (1) polymorphs, (2) hydrates, (3) desolvated solvates, and (4) amorphous forms. Results. These flow charts (decision trees) are suggested as tools to develop information on pharmaceutical solids for both scientific(More)
The following paper describes the International Society for Pharmaceutical Engineering (ISPE)-sponsored Blend Uniformity and Content Uniformity Group’s proposed modifications to the withdrawn FDA draft guidance document for industry “Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment.” The modifications(More)
The FDA withdrew the draft guidance document for industry “Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment.” An FDA’s primary concern was a lack of confidence that the results from USP <905> Uniformity of Dosage Units testing ensure the content uniformity of a batch. ISPE sponsored the Blend Uniformity and(More)
  • C P Hoiberg
  • 1989
In the May 23, 1985 issue of the New England Journal of Medicine, Dr. Sedman et al. reported that many drug products that are routinely administered in parenteral therapy contain aluminum. From a manufacturing and control perspective, the Agency had obtained considerable information and data regarding (1) sources of aluminum contamination, (2) types of(More)