Abstract:
:In a multicentre study involving six laboratories, a microbiological assay was performed on three neomycin samples containing respectively, 0.12, 2.1 and 11% (m/m) of neomycin C, as well on a pure neomycin C sample. The potency was determined according to the European Pharmacopoeia method but using a neomycin B base standard. The relative standard deviations between laboratories (RSD) on the potencies varied from 4.8 to 50%, depending on the sample examined. The RSD increased with the neomycin C content of the samples and the highest RSD values were observed for the pure neomycin C sample. The activity of neomycin C relative to neomycin B was found to be 62% by diffusion (RSD:41%) and 56% by turbidimetry (RSD: 50%). This confirmed that the presence of neomycin C in a neomycin sample influences the reproducibility of the microbiological assay. T estimate the influence of this effect on official standard, their composition was verified by liquid chromatography. The neomycin C base content of the standards varied between 0.4 and 5.8% (m/m). Based on the results obtained and on formerly published reports discussing problems encountered with microbiological assay of neomycin, it is proposed to introduce liquid chromatography in official monographs to replace microbiological assay.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Adams E,Liu L,Dierick K,Guyomard S,Nabet P,Rico S,Louis P,Roets E,Hoogmartens Jdoi
10.1016/s0731-7085(97)00247-1subject
Has Abstractpub_date
1998-08-01 00:00:00pages
757-66issue
4-5eissn
0731-7085issn
1873-264Xpii
S0731-7085(97)00247-1journal_volume
17pub_type
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