Study on sulfate radical moles in amikacin sulfate structure in pharmacopeia

Yu Yongjin

Chinese Pharmaceutical Journal ›› 1999, Vol. 34 ›› Issue (11) : 771-772.

Chinese Pharmaceutical Journal ›› 1999, Vol. 34 ›› Issue (11) : 771-772.
药品质量及检验

Study on sulfate radical moles in amikacin sulfate structure in pharmacopeia

  • Yu Yongjin
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Abstract

OBJECTIVE:To study the relationship between acidity and potency of amikacin sulfate & the content of sulfate radical in sample.METHODS:The sulfate radical moles in amikacin sulfate was assaged by barium sulfate gravimetric method,the potency and acidity of sample was determined.RESULTS:The content of sulfate radical in sample was related to its potency and acidity.CONCLUSION:Sulfate radical moles in Chinese Pharmacopeia (edition 1995) was not a match for the acidity range & content requirement. Here are three suggestions to adjust:①Modifying the sulfate radical moles in amikacin sulfate structure to less than 1.8.Then both the carrent acidity & content limit are not changed.②Adopting the regulation in USP ⅩⅩⅢ.③Readjusting the acidity range to pH 3.0~7.0 nad the equivalent of not less than 675μg amikacin per mg.

Key words

amikacin sulfate / sulfate radical / acidity / potency

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Yu Yongjin . Study on sulfate radical moles in amikacin sulfate structure in pharmacopeia[J]. Chinese Pharmaceutical Journal, 1999, 34(11): 771-772

References

1 Florey K.Analytical Profiles of Drug Substances.Vol.12.New York:Academic Press,Inc.,1983:37. 2 Kawaguchi H,Naito T,Nakagawa S,et al.BBK-8 a new semisynthetic amineglycoside antbiotic.J Antibiot,1997,25:695. 3 中国药典,1995年版二部.1995:908. 4 USP.ⅩⅩⅢ,NF Ⅹ Ⅷ,1995:76.

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