Calidad fisicoquímica de lactosa monohidrato materia prima de un laboratorio farmacéutico nacional

• Autor: Alfaro Verde, Lizet Janet
• Formato: tesis de grado
• Fecha de Publicación: 2018
• Institución: Universidad Nacional de Trujillo
• Repositorio: UNITRU-Tesis
• Lenguaje: español
• OAI Identifier: oai:dspace.unitru.edu.pe:20.500.14414/10688
• Enlace del recurso: https://hdl.handle.net/20.500.14414/10688
• Nivel de acceso: acceso abierto
• Materia: control de calidad, fisicoquímicos, Lactosa monohidrato

In the present report, the physicochemical quality evaluation of three batches of lactose monohydrate as raw material of a national pharmaceutical laboratory was carried out through physicochemical parameters such as description of the sample, solubility and identification by infrared spectrophotometry (IR) , and specific tests such as the determination of water by Karl Fischer, transparency and color of the solution, optical rotation, acidity or alkalinity, loss on drying, residues of incineration and proteins and impurities that absorb light; which were based on the analytical technique of the laboratory, taking as reference the United States Pharmacopeia (USP 40). The physicochemical parameters comply with the specifications established in the analysis protocol of the quality control department for lactose monohydrate as a raw material