Stability evaluation of 7% chloral hydrate syrup contained in mono and multi-dose bottles under room and refrigeration conditions.

BUSTOS-FIERRO, C; OLIVERA, ME.; MANZO, PG; JIMENEZ KAIRUZ, AF

Farmacia Hospitalaria

Sociedad Española de Farmacia Hospitalaria, Editorial Aula Médica.

Lugar: Madrid; Año: 2013 vol. 37 p. 4 - 4

1130-6343

urpose: To evaluate the stability of an extemporaneously prepared 7 % chloral hydrate syrup under different conditions of storage and dispensing. Methods: Three batches of 7 % chloral hydrate syrup were prepared. Each batch was stored in 50 light-resistant glass containers of 60 mL with child-resistant caps and in two bottles of 1000 mL to simulate two forms of dispensing, mono and multi-dose, respectively. Twenty five mono-dose bottles and a multi-dose bottle of each batch were stored under room conditions (20±1 °C) and the rest of the samples were stored in the fridge (5±2 °C). The physical, chemical and microbiological stability was evaluated for 180 days. Stability was defined as retention of at least 95 % of the initial concentration of chloral hydrate, the absence of both visible particulate matter, or color and/or odor changes and the compliance with microbiological attributes of non-sterile pharmaceutical products. Results: At least 98 % of the initial chloral hydrate concen