Effects of temperature and relative humidity on the solid-state chemical stability of ranitidine hydrochloride.

The chemical stability of ranitidine HCl in solution and in the solid state at various temperatures was investigated by high-performance liquid chromatography. Ranitidine HCl was unstable in lower pH buffer solutions, and the percent degradation after 72 h increased as the pH of the buffer solution was reduced. The percent degradation in the unbuffered solution increased dose dependently. The critical relative humidity (CRH) of the ranitidine HCl bulk powder was approximately 67% relative humidity (RH). The amount of water adsorbed onto the sample above the CRH was proportional to the RH level. The percent degradation of the powder below 50% RH was almost negligible because, at this level, it was a solid. The percent degradation at 60-70% RH was higher than that above 70% RH. Ranitidine HCl powder was unstable around the CRH.

[1]  J. Carstensen,et al.  Decomposition of aspirin in the solid state in the presence of limited amounts of moisture III: Effect of temperature and a possible mechanism. , 1988, Journal of pharmaceutical sciences.

[2]  J. Carstensen,et al.  Decomposition of aspirin in the solid state in the presence of limited amounts of moisture II: Kinetics and salting-in of aspirin in aqueous acetic acid solutions. , 1988, Journal of pharmaceutical sciences.

[3]  V. Gil,et al.  Nuclear magnetic resonance study of the configurational equilibria of ranitidine in solution , 1987 .

[4]  J. Carstensen,et al.  Decomposition of aspirin in the solid state in the presence of limited amounts of moisture. , 1985, Journal of pharmaceutical sciences.

[5]  S. Yoshioka,et al.  Stability of solid dosage forms. I. Hydrolysis of meclofenoxate hydrochloride in the solid state. , 1982 .

[6]  M. Hanano,et al.  Kinetic Studies on Decomposition of Glutathione. I. Decomposition in Solid State , 1978 .

[7]  U. Kesselring,et al.  Effect of temperature and relative humidity on nitrazepam stability in solid state. , 1977, Journal of pharmaceutical sciences.

[8]  J. Carstensen,et al.  Degradation mechanisms for water-soluble drugs in solid dosage forms. , 1969, Journal of pharmaceutical sciences.

[9]  J. Akbuğa,et al.  Moisture adsorption and effect of adsorbed water on the powder and compaction properties of ranitidine hydrochloride , 1991 .

[10]  G. Zografi States of Water Associated with Solids , 1988 .

[11]  S. Yoshioka,et al.  Kinetics and mechanism of the solid-state decomposition of propantheline bromide. , 1986, Journal of pharmaceutical sciences.