- On the analytics and the stability of atropine sulphate and scopolamine hydrobromide. III. Studies on the stability of tropane alkaloids; Part 80: Contributions to problems concerning the use of plastic containers for liquid pharmaceuticals
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On evaluating their investigations, the authors discuss the degradation mechanism of tropane alkaloids in aqueous solution. As evidenced by competitive and consecutive reactions (hydrolysis, dehydration, dimerization), the degradation mechanism is characterized by a complicated course. Apart from temperature, a series of other factors, above all the pH value, exerts a considerable effect on the stability of both the alkaloids. Unbuffered solutions are more stable than buffered ones. The isothermal short-time test is not suitable for stability prediction. In the long-time test it was found that unbuffered aqueous atropine sulphate solutions still contained 90% of their initial drug content after 18 months' storage in low-density polyethylene containers at 20° C. Scopolamine hydrobromide solutions showed an almost analogous behavior. Of the container materials tested, low-density polyethylene bottles have been found to be best suited.
- Jira Th.,Pohloudek Fabini
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p. 520 - 523
(2007/10/02)
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- Analysis and stability of atropine sulfate and scopolamine hydrobromide. 1. Qualitative detection of alkaloids in the presence of their decomposition products. 73. Contribution to the problem of the use of plastic receptacles for liquid pharmaceuticals
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The authors deal with the qualitative determination of tropane alkaloid salts (atropine sulphate and scopolamine hydrobromide) in aqueous solutions in the presence of their decomposition products using thin-layer chromatography. Aqueous solutions of these tropane alkaloid salts were tested for stability after storage in glass and polyethylene containers under various conditions (pH value, temperature, ultra-violet irradiation, oxidative effects). Besides tropine, apoatropine, alpha- and beta-belladonine, further decomposition products showing a basic reaction (and in part not yet identified) were detected. The stability of solid atropine sulphate was studied by means of differential thermal analysis and mass spectrometry.
- Jira,Pohloudek-Fabini
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p. 645 - 649
(2007/10/02)
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