Stability of polymorphic forms of ranitidine hydrochloride.

摘要: Ranitidine-HCl can exist in two different polymorphic forms: form I (m.p. 134-140 degrees C) and II 140-144 C). In the present study stability of ranitidine-HCl to a selection powder pretreatments, reflect conditions which might occur manufacturing procedures, also limited range storage was investigated. The original samples used were characterised by X-ray diffraction (XRPD), hot stage microscopy (HSM) differential scanning calorimetry (DSC). A quantitative XRPD method for determining fraction presence used. data analysed using regression techniques artificial neural networks (ANN). technique then monitor relative proportion each treated sample. Pretreatments included (i) mixing with or common excipients (ii) compression grinding (iii) contact solvents (followed drying) before storage. Storage involved three temperatures (20 C, 30 42 humidities (45% RH; 55% 75% RH). Samples stored period 6 months. factorial design No increase II:form ratio observed following pretreatment processes: introduction nuclei into I; at 5 15 tons; normal processes; addition isopropanol (IPA) water/IPA mix followed drying. process where water added (with most all dissolving), drying liquefied mass led II. On room temperature (20-30 C), low humidity (45-55% RH), an air-tight container there no ratio. I/form mixes, particularly high humidity, resulted preferential loss (compared I). Loss greater C/75% RH than 20 RH. Form preferentially lost under created saturated solution potassium carbonate RH) elevated C. This environment shown be acidic.