期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 36, 期 5, 页码 983-988出版社
ELSEVIER
DOI: 10.1016/j.jpba.2004.08.031
关键词
ampicillin trihydrate; GC; residual solvent; crystal stability; XRD
In the present work. the relationship between residual solvents concentration and ampicillin trihydrate crystals stability has been investigate. The amounts of residual solvents determined by GC, X-ray powder diffraction (XRPD) and Fourier transform infrared spectroscopy (FT-IR) were used for characterization of solid state. The obtained results have shown good relationship between concentration of methylene chloride (as a critical residue solvent) and degree of ampicillin trihydrate crystallinity. As with the increasing methylene chloride, concentration in the sample the degree of crystallinity decreased after stability test. From this relationship, critical concentration of methylene chloride into the ampicillin trihydrate is obtained and the results can be used for improving the large-scale production of ampicillin trihydrate. (C) 2004 Published by Elsevier B.V.
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