Stability of Ephedrine Sulfate at Ambient Temperature and 4 deg C in Polypropylene Syringes.

The stability of 5 mg/mL ephedrine sulfate in 0.9% sodium chloride in 10-mL polypropylene syringes stored at ambient temperature and at 4 deg C for up to 60 days was investigated. Concentration levels of ephedrine sulfate were determined by means of a high-performance liquid chromatography stability-indicating assay at 0, 1, 4, 7, 14, 30, 45 and 60 days after preparation of the syringes. Benzyl alcohol, which was added as a preservative, did not interfere with the assay. The injections in polypropylene syringes were stable for up to 60 days at both ambient temperature and at 4 deg C. The pH of the ephedrine sulfate injections did not change appreciably in a particular direction during the 60-day study period. These data support the stability of ephedrine sulfate under the storage conditions investigated in this study.

The stability of remifentanil hydrochloride and propofol mixtures in polypropylene syringes and polyvinylchloride bags at 22 degrees-24 degrees C.

IMPLICATIONS: Remifentanil and propofol mixtures may be prepared extemporaneously. This study demonstrated that such mixtures are stable for 0 to 36 h, depending on relative concentrations of the drugs and the storage container used. The most stable mixtures were stored in syringes and used large concentrations of the two drugs.

Stability of ondansetron hydrochloride and 12 medications in plastic syringes.

The stability and compatibility of ondansetron hydrochloride with neostigmine methylsulfate, naloxone hydrochloride, midazolam hydrochloride, fentanyl citrate, alfentanil hydrochloride, atropine sulfate, morphine sulfate, meperidine hydrochloride, propofol, droperidol, metoclopramide monohydrochloride, and glycopyrrolate were studied. Ondansetron 1.33 or 1.0 mg/mL was combined with 0.9% sodium chloride injection and each of the 12 drugs in duplicate in plastic syringes (or glass for propofol). The syringes were stored at 21.8-23.4 or 4 degrees C in the dark, except for those containing propofol, which were stored at ambient temperature. Samples were removed at 0, 4, 8, and 24 hours for analysis by high-performance liquid chromatography and pH measurement; the propofol-containing samples were removed at 0, 1, 2, and 4 hours. Syringes were visually assessed for color and clarity, and particulate content was measured with a particle counter at the end of the study period. All solutions containing ondansetron retained more than 90% of their initial ondansetron concentration. Solutions containing each of the other drugs except droperidol retained more than 90% of their initial concentration of these drugs. The solutions containing droperidol retained more than 90% of their initial droperidol concentration for up to eight hours at ambient temperature but precipitated quickly at 4 degrees C. In combinations of ondansetron 1.33 or 1.0 mg/mL and 10 of 12 drugs, all drugs were stable for 24 hours in plastic syringes at 23 and 4 degrees C; ondansetron hydrochloride 1.0 mg/mL and propofol 1.0 and 5.0 mg/mL in admixtures were stable for 4 hours, and droperidol on its own and combined with ondansetron 1.0 mg/mL was stable for no more than 8 hours at ambient temperature.

Stability of cefmetazole-doxycycline mixtures in sodium chloride and dextrose injections.

This study involved the mixing of cefmetazole 1 and 2 Gm with doxycycline 100 and 200 mg, in sodium chloride and dextrose injections. The mixtures were stored either at ambient temperature for 96 h or at 4 degrees C for 168 h followed by 8 h at ambient temperature. HPLC assay of both cefmetazole and doxycycline levels were performed at prescribed sampling times. Cefmetazole 1 Gm in doxycycline 100 and 200 mg mixtures, in sodium chloride injection was not stable up to 4 h, but cefmetazole 2 Gm in doxycycline 100 and 200 mg mixtures, in sodium chloride injection was stable for up to 24 h. The cefmetazole controls were stable for 72 h in sodium chloride injection. Cefmetazole 1 Gm with doxycycline 100 mg, in dextrose injection was stable up to 72 h. The 2 Gm cefmetazole and 100 mg doxycycline mixture in dextrose injection was stable for 96 h. Cefmetazole 1 Gm and doxycycline 200 mg in dextrose injection was stable up to 96 h, but the 2 Gm cefmetazole-200 mg doxycycline mixture was only stable for 72 h. Cefmetazole controls in dextrose injection were stable for 24 h. Doxycycline 100 and 200 mg were stable with cefmetazole 1 and 2 Gm, in both sodium chloride and dextrose injections for 96 h at ambient temperature. Doxycycline control solutions were also stable for 96 h. Cefmetazole 1 and 2 Gm and doxycycline 100 and 200 mg were generally stable in both sodium chloride and dextrose injections at 4 degrees C for 168 h, and at ambient temperature for 8 h.(ABSTRACT TRUNCATED AT 250 WORDS)

Stability of ceftazidime in plastic syringes and glass vials under various storage conditions.

The stability of ceftazidime solutions (100 and 200 mg/mL) in plastic syringes and glass vials under various storage conditions was examined. Solutions of ceftazidime 100 and 200 mg/mL in sterile water were placed in polypropylene plastic syringes or glass vials and stored (1) at 21-23 degrees C for up to 8 hours, (2) at 4 degrees C for up to 96 hours, (3) at -20 degrees C for 28 days and then 21-23 degrees C for up to 8 hours, (4) at -20 degrees C for 28 days and then 4 degrees C for up to 96 hours, (5) at -20 degrees C for 91 days and then 21-23 degrees C for up to 8 hours, or (6) at-20 degrees C for 91 days and then 4 degrees C for up to 96 hours. Samples were withdrawn from each syringe and vial at designated times and assayed by high-performance liquid chromatography. Solutions were judged to be stable if drug concentrations remained above 90% of the initial values. The number of particles in each container under each storage condition was also evaluated. Ceftazidime was stable under all storage conditions. In all containers, particulate matter was within USP specifications for small-volume injections, with no change in particle count as a result of the freezing and thawing. Ceftazidime in sterile water in either glass vials or plastic syringes is stable for 8 hours at room temperature or 96 hours at 4 degrees C when such storage occurs (1) immediately after constitution, (2) after 28 days of frozen storage, or (3) after 91 days of frozen storage.

Stability of mupirocin ointment (Bactroban) admixed with other proprietary dermatological products.

This study involved the mixing of 1:1 combinations of Bactroban (mupirocin) Ointment 2% with various cream, lotion, ointment, gel, solution and liquid soap formulations with storage at 37 degrees C for 60 days. The mixtures were assayed for mupirocin content at 0, 15, 30, 45 and 60 days using a high-pressure liquid chromatographic (HPLC) assay. At the time of preparation of these admixtures, Bactroban Ointment is chemically and physically compatible with all of the topical dermatological products studied except for Valisone lotion where a physical incompatibility is immediately observed. Admixtures of Hibiclens liquid soap or Lotrimin solution with Bactroban Ointment were stable throughout the entire 60-day study. Combinations of Lotrimin cream, Hytone cream, Valisone ointment or Vytone cream with Bactroban Ointment also retained chemical stability of mupirocin for the entire period even though two layers were observed and mixing was required to restore a physically homogenous mixture. Other Bactroban Ointment admixtures were found to be either chemically stable for mupirocin for periods less than 60 days or physically incompatible mixtures were observed upon storage. No conclusions were drawn from these studies concerning the efficacy or safety of any of these products when used in extemporaneously prepared combinations.

Stability of ranitidine in intravenous admixtures stored frozen, refrigerated, and at room temperature.

The stability of ranitidine in concentrations of 0.5, 1.0, and 2.0 mg/mL in admixtures with commonly used i.v. fluids was studied. The admixture vehicles were 0.9% sodium chloride, 5% dextrose, 10% dextrose, 5% dextrose and 0.45% sodium chloride, and 5% dextrose with lactated Ringer's (DLR) injections in polyvinyl chloride bags. Three bags were prepared for each test solution and stored under each of the following conditions: seven days at room temperature (23 +/- 1 degrees C) in normal laboratory lighting, 30 days at 4 degrees C, and 60 days at -20 degrees C followed by either seven days at room temperature (in light) or 14 days at 4 degrees C. Ranitidine content was determined by high-performance liquid chromatography at several intervals. Color, clarity, and pH were also examined. Ranitidine concentrations remained greater than or equal to 90% of initial concentrations under all storage conditions except in the frozen DLR admixtures. Drug loss in the DLR admixtures was greatest at the lower ranitidine concentrations. The only visual changes were yellow color in the thawed DLR admixtures and those containing ranitidine 2.0 mg/mL in 5% dextrose and 0.45% sodium chloride. Slight increases in the pH of some admixtures were noted. Ranitidine is stable for seven days at room temperature and 30 days at 4 degrees C at all concentrations and in all vehicles studied. At the studied concentrations, the drug is stable in admixtures frozen for 60 days and stored for seven days at room temperature or 14 days refrigerated, except in DLR admixtures; these admixtures should not be stored frozen.

Stability of ranitidine hydrochloride at dilute concentration in intravenous infusion fluids at room temperature.

The stability of ranitidine at low concentration (0.05 mg/mL) in five intravenous infusion solutions (0.9% sodium chloride, 5% dextrose, 10% dextrose, 5% dextrose with 0.45% sodium chloride, and 5% dextrose with lactated Ringer's injections) was studied. Admixtures were stored for seven days at room temperature in 150-mL and 1-L polyvinyl chloride infusion bags. Ranitidine stability in 0.9% sodium chloride injection and in 5% dextrose injection was also examined for up to 28 days, and these data were compared with data obtained at higher ranitidine concentrations (0.5-2.0 mg/mL). At intervals during the storage periods, color, clarity, and solution pH were examined and ranitidine content was determined by a stability-indicating high-performance liquid chromatographic assay. Ranitidine content remained greater than 90% of the initial concentration for more than 48 hours in all infusion fluids except 5% dextrose with lactated Ringer's injection. No visual changes or appreciable changes in pH were observed for any of the solutions. At the dilute concentration, ranitidine was markedly more stable after eight hours in 0.9% sodium chloride injection than in 5% dextrose injection. In 0.9% sodium chloride injection, ranitidine concentrations remained above 95% for up to 28 days, but drug concentrations in 5% dextrose injection fell below 90% after seven days. Stability in 5% dextrose injection improved as ranitidine concentrations increased from 0.05 to 2.0 mg/mL. Ranitidine (0.05 mg/mL) is stable for at least 48 hours at room temperature in all infusion fluids tested except 5% dextrose with lactated Ringer's injection.