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KMID : 0869619880050010026
Journal of Korean Society of Hospital Pharmacists
1988 Volume.5 No. 1 p.26 ~ p.45
The Stability Study on Pharmaceutical Products Manufactured in Hospital Pharmacy
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Abstract
The stability tests on the preparations produced at our hospital were conducted in order to establish the expiration date of each preparation. Fifteen preparations such as ophthalmic solution, nasal drops, injections, syrups and oral suspensions were chosen for the study and checked their stability in terms of active ingredients, visual changes and PH from 8 days to 6 months. The contents of ingredients and the decomposition products in the preparations were measured by using high performance liquid chromatograph or by the methods described in Korean Pharmacopoeia on each preparation. The results of stability tests are as follows. 1) Penicillin G sodium ophthalmic solution (T-PC), povidone iodine ophthalmic solution(T-PVP) and cefazoline sodium ophthalmic solution(T-Cefa) were stable for 4 days, 7 days and 1 month at refrigerated temparature, respectively. Chloramphenicol sodium succinate and prednisolone acetate ophthalmic solution(T-CTM) and chloramphenicol sodium succinate ophthalmic solution(T-CM) were stable for 4 months at refrigerated temperature, and pilocarpine HCl ophthalmic solution(T-Pilo) were stable for 4 months either at room or at refrigerated temperature. Gentamicin sulfate ophthalmic solution(T-GM) prednisolone acetate ophthalmic solution(T-CT), atropine sulfate ophthalmic solution(T-AT), homatropine HBr ophthalmic solution (T-HA) were stable for more than 4 months either at room or at refrigerated temperature. 2) Phenylephrine HCl nasal drops were stable for more than 2 months at refrigerated temperature. 3) Phenylephrine HCl injections and procaine HCl injection were stable for more than 2 months. 4) Diazepam syrups were stable for 28 days in light-protected glass containers at refrigerated temperature. 5) Primidone oral suspension and dl-¥á-tocopheryl acetate oral suspension were stable for 6 months either at room or at refrigerated temperature.
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