![]() A background analysisĪrticleTitleQuantitative investigation of X-ray diffraction by “amorphous” polymers and some other noncrystalline substances Physical Characterization of Pharmaceutical SciencesĪrticleTitleQuantitative X-ray investigation on the crystallinity of cellulose fibers. Occurrence Handle10.1016/0378-5173(94)90188-0ĪrticleTitleQuantitative crystallinity determinations for beta-lactam antibiotics by solution calorimetry: correlations with stability Occurrence Handle10.1016/0378-5173(94)90219-4ĪrticleTitleAssessment of the degree of disorder in crystalline solids by isothermal microcalorimetry Draft guidanceĪrticleTitlePharmaceutical solids: a strategic approach to regulatory considerationsĪrticleTitleThe quantitative analysis of crystallinity using FT-Raman spectroscopyĪrticleTitleAssessment of disorder in crystalline solids Department of Health and Human Services, Food and Drug AdministrationĪrticleTitleProcess analytical technology-a framework for innovative pharmaceutical manufacturing and quality assurance. InstitutionalAuthorNameInternational Conference on Harmonisation (ICH)ĪrticleTitleDraft guidance on Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances The first evidence of crystallization can serve as an indicator of the potential physical instability of the product.ĪrticleTitleEffect of formulation additives on the dissolution behavior of tetracycline antibioticsĪrticleTitleStability and several physical properties of amorphous and crystalline form of indomethacinĪrticleTitleSome pharmaceutical properties of novobiocinĪrticleTitleCryoprotective effect of saccharides on denaturation of catalase by freeze-dryingĪrticleTitleEffect of mannitol crystallinity on the stabilization of enzymes during freeze-dryingĪrticleTitleDecreased protein-stabilizing effects of cryoprotectants due to crystallizationĪrticleTitleCrystallization of indomethacin from the amorphous state below and above its glass transition temperature High-intensity XRD can discern subtle changes in the lattice order of materials. The estimated limit of detection of crystalline sucrose in an amorphous matrix was 0.2% w/w, a considerable improvement over the reported value of ∼1% w/w with a conventional XRD. The in situ crystallization approach circumvented the problem of inhomogeneity in mixing-a potentially serious issue at extreme mixture compositions. The gradual crystallization of sucrose is analogous to a series of physical mixtures with increasing content of the crystalline component. The synchrotron XRD technique allowed powder diffraction patterns to be recorded with a time resolution of 40 ms. ![]() An algorithm was developed for separation of the crystalline and amorphous intensities from the total diffraction pattern. The crystallization of amorphous sucrose was monitored in situ, isothermally at several temperatures in the range of 90 to 160☌. Methodsĭiffraction data were acquired at the European Synchrotron Radiation Facility (France) using a 2-D charge-coupled device detector. The aim of this study was to develop a highly sensitive powder X-ray diffraction (XRD) technique for quantification of crystallinity in substantially amorphous pharmaceuticals, utilizing synchrotron radiation and a 2-D area detector.
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