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安乃近常混有少量副产物4-N-去甲基安乃近,即1-苯基-2,3-二甲基-4-氨基吡唑酮-[5]-甲基磺酸钠。为保证药品质量,中国药典规定注射用原料含4-N-去甲基安乃近不得超过0.2％。目前,国内部分产品中上述杂质含量在限度上下波动,而药典所采用的香荚醛目视比色法的分辨率约为0.1％,常引起检验结果的分歧。日本药局方第十改正版(1980)采用苯甲醛比浊法,灵敏度更差,其检出限度为0.7～1.0％,因而寻找更灵敏的测定方法对保证和提高安乃近质量有重要意义。
Analgin recently mixed with a small amount of by-product 4-N- desmethyl pyrimidine, which is 1-phenyl-2,3-dimethyl-4-aminopyrazolone - [5] - sodium methanesulfonate . In order to ensure the quality of medicines, the Chinese Pharmacopoeia stipulates that the raw materials for injection containing 4-N-demethylation should not exceed 0.2%. At present, the content of the above impurities in some domestic products fluctuates within limits, whereas the resolution of the visual colorimetric method used in Pharmacopoeia is about 0.1%, which often leads to the differences of test results. Japanese Pharmacopoeia tenth revised edition (1980) using benzaldehyde turbidimetry method, the sensitivity is even worse, the detection limit of 0.7 to 1.0%, so looking for a more sensitive determination of the method to ensure and improve the quality of metamizole important .