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结晶性固体物质在一定压力下都有一定熔化温度。对纯的结晶物质而言其熔点十分敏锐,一般熔距不超过0.5℃。若受到微量杂质存在的影响,可使它的熔点下降和熔化敏锐程度减低而使熔距增大。由于结晶性固体物质熔点下降与该物质中存在的杂质量有关,因此各国药典均采用测定药品的熔点或熔距作为鉴别和检查药物纯度的方法。
Crystalline solid material under a certain pressure has a certain melting temperature. The melting point of pure crystalline material is very sharp, the general melting distance does not exceed 0.5 ℃. If it is affected by the presence of trace impurities, it can make its melting point decreased and the degree of melting less sensitive to increase the melting distance. Since the melting point of the crystalline solid material is reduced with the amount of impurities present in the material, the pharmacopoeias of each country determine the melting point or melting distance of the drug as a method of identifying and checking the purity of the drug.