[Analysis and stability of atropine sulfate and scopolamine hydrobromide. 3: Studies on the stability of tropane alkaloids; 80: contribution to problems in the use of plastic containers for liquid pharmaceuticals].
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 degrees C. Scopolamine hydrobromide solutions showed an almost analogous behaviour. Of the container materials tested, low-density polyethylene bottles have been found to be best suited.
D001285:Atropine / Q000032:analysis*; D004349:Drug Packaging; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D010969:Plastics; D012601:Scopolamine / Q000032:analysis*; D013696:Temperature; D013997:Time Factors
D010969:Plastics; D001285:Atropine; D012601:Scopolamine
Zur Analytik und Stabilität von Atropinsulfat und Scopolaminhydrobromid.