Escolar Documentos
Profissional Documentos
Cultura Documentos
Advantages
Its capacity for: Nondestructive testing
Analysis of final dosage form
Detection of Crystalline Impurities Detection of changes in morphology during
production
X-Ray Diffraction
Schematic Diagram
Applications
Drug discovery: Determining whether a drug is
Polymorphic Forms
Effects of Processing
Monitoring of Crystallization Process
Monitoring Drying of Active Pharmaceutical Ingredient Monitoring the Influence of Milling of Active
Pharmaceutical Ingredient
Monitoring Wet Granulation Processes
Effects of Freeze Drying Processes
Stability Studies
Nonambient Conditions X-ray Powder Diffraction o Phase transitions are directly monitored during analysis o temperature controlled XRPD (TC-XRPD)-Gives fruitful information in combination with Differential Scanning Calorimetry (DSC) on phase diagram of substance o humidity controlled XRPD (HC-XRPD)-Hydration or Dehydration processes are analyzed. By correlating Dynamic Vapor sorption (DVS) analysis and HC-XRPD weight changes are assigned to polymorphic phase trans.
Drug Regulation
PANalytical- Quick & Reliable screening of tablets
without removing blister packing. The typical measurement time for this technique takes between 10 and 30 minutes, depending upon thickness and properties of the tablets/capsules Scattering from the mainly amorphous polymer used for the blister material produces only a slightly increased background Aluminum lidding is evidenced by just two characteristic Bragg reflections at higher angles
Counterfeit Medicines
Summary
Compatibility Studies
Control of ingredients- limit of detection 0.05% Crystallography and crystal structure determination Crystallintiy determination R&D application Phase analysis and polymorph screening Batch and dosage uniformity
References
Groen, H.; Mougin, P.; Thomas, A.; White, G.; Wilkinson,
D.; Hammond, R. B.; Lai, X.; Roberts, K. J. Ind. Eng. Chem.Res. 2003, 42, 4888. Cameron, M.; Zhou, G. X.; Hicks, M. B.; Antonucci, V.; Ge, Z.; Lieberman, D. R.; Lynch, J. E.; Shi, Y. J. J. Pharm.Biomed. Anal. 2002, 28, 137. Chan, H. K.; Doelker, E. Drug Dev. Ind. Pharm. 1985, 11,315. Otsuka, M.; Matsuda, Y. Drug Dev. Ind. Pharm. 1993, 19,2241.