Update on room-temperature stability of drug products labeled for refrigerated storage

1990 ◽  
Vol 47 (11) ◽  
pp. 2522-2524
Author(s):  
Mazie F. Dalton-Bunnow ◽  
Fred J. Halvachs
1975 ◽  
Vol 32 (11) ◽  
pp. 1084-1089
Author(s):  
Alan W. Hopefl ◽  
Robert C. Barger ◽  
J. Ogden Owens

2006 ◽  
Vol 319 ◽  
pp. 151-156 ◽  
Author(s):  
Y. Hiki ◽  
M. Tanahashi ◽  
Shin Takeuchi

In a hydrogen-doped metallic glass, there appear low-temperature and high-temperature internal friction peaks respectively associated with a point-defect relaxation and the crystallization. The high-temperature-side slope of low-temperature peak and also the low-temperature-side slope of high-temperature peak enhance the background internal friction near the room temperature. A hydrogen-doped Mg-base metallic glass was proposed as a high-damping material to be used near and somewhat above the room temperature. Stability of the high damping was also checked.


Author(s):  
MEITAL ZUR ◽  
DAVID STEPENSKY ◽  
PAVEL GORENBEIN

Objective: To characterize the differences in stability of L-adrenaline in adrenaline ampoules from different manufacturers that are used by the Israel Defense Forces (IDF). Methods: Adrenaline ampoules from three different vendors (Products A, B and C; 52, 13, and 19 batches, respectively) were purchased by the IDF and were stored under the recommended storage conditions (room temperature) for different time periods. The content of L-adrenaline in these samples was determined using a chiral high-performance liquid chromatography (HPLC) assay with UV detection. Results: The three analyzed drug products showed very dissimilar patterns of L-adrenaline degradation. The content of L-adrenaline in Product C was variable and declined below the 85% threshold much earlier than at the end of the 24-months storage period. Products A and B had less variable content of L-adrenaline and were more stable. Conclusion: L-adrenaline is prone to degradation in solution. Its content in adrenaline ampoules from certain vendors can decline rapidly, below the stipulated threshold, and compromise their clinical effectiveness (e. g., during resuscitation). Stability of adrenaline ampoules from individual vendors should be analyzed at different storage conditions, using a chiral HPLC-based assay, to define the shelf-life period that can differ substantially between the vendors.


1991 ◽  
Vol 48 (4) ◽  
pp. 683-684
Author(s):  
James A. Sterchele ◽  
Raymond C. Stierer

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029083 ◽  
Author(s):  
Tri-Hung Nguyen ◽  
Peter Lambert ◽  
Rajpreet Singh Minhas ◽  
Claire McEvoy ◽  
Kim Deadman ◽  
...  

IntroductionOxytocin, administered via injection, is recommended by WHO for the prevention and treatment of postpartum haemorrhage. However, the susceptibility of oxytocin injection to thermal degradation has led WHO and UNICEF to recommend cold-chain storage of all oxytocin products. Nevertheless, some oxytocin products supplied to the global market are labelled for storage at ≤25°C, often with a shorter shelf-life relative to products labelled for refrigeration. Differences in labelled storage requirements can lead to uncertainties among stakeholders around the relative stability of oxytocin products and specifically whether ≤25°C products are more resistant to degradation. Such confusion can potentially influence policies associated with procurement, distribution, storage and the use of oxytocin in resource-poor settings.ObjectivesTo compare the stability of oxytocin injection ampoules formulated for storage at ≤25°C with those labelled for refrigerated storage.DesignAccelerated and temperature cycling stability studies were performed with oxytocin ampoules procured by the United Nations Population Fund (UNFPA) from four manufacturers.MethodUsing oxytocin ampoules procured by UNFPA, accelerated stability (up to 120 days) and temperature cycling (up to 135 days between elevated and refrigerated temperatures) studies were performed at 30°C, 40°C and 50°C. Oxytocin content was quantified using a validated HPLC-UV method.ResultsAll ampoules evaluated exhibited similar stability profiles under accelerated degradation conditions with the exception of one product formulated for ≤25°C storage, where the rate of degradation increased at 50°C relative to other formulations. Similar degradation trends at elevated temperatures were observed during temperature cycling, while no significant degradation was observed during refrigerated periods of the study.ConclusionOxytocin ampoules formulated for non-refrigerated storage demonstrated comparable stability to those labelled for refrigerated storage and should not be interpreted by stakeholders as offering a more stable alternative. Furthermore, these products should not be procured for use in territories with high ambient temperatures, where all oxytocin injection products should be supplied and stored under refrigerated conditions.


2005 ◽  
Vol 68 (11) ◽  
pp. 2356-2361 ◽  
Author(s):  
JIN KYUNG KIM ◽  
ELAINE M. D'SA ◽  
MARK A. HARRISON ◽  
JUDY A. HARRISON ◽  
ELIZABETH L. ANDRESS

Listeria monocytogenes can survive and grow in refrigerated foods with pH values of approximately 4.0 to 5.0 and salt concentrations of 3 to 4%. Home-fermented refrigerator dill pickles fit this description. Contamination of this product with L. monocytogenes could cause serious problems because these items are not heated prior to consumption. L. monocytogenes survival and growth patterns were investigated in refrigerator dill pickles at 1.3, 3.8, and 7.6% salt concentrations. Pickling cucumbers were dipped into an inoculum of L. monocytogenes, brine mixtures were added, and cucumbers were held at room temperature for 1 week and then refrigerated for up to 3 months. The pH, NaCl percentage, titratable acidity percentage, and total populations of Listeria and aerobic, psychrotrophic, and lactic acid bacteria were measured at the addition of brine, after 2, 4, and 7 days of storage at room temperature, and then weekly during refrigerated storage. The initial Listeria population was 5.4 to 5.6 log CFU/cm2 on cucumber surfaces and 3.9 to 4.6 log CFU/g internally. There was an approximate 0.3- to 1-log increase during room temperature fermentation followed by a population decline during refrigerator storage, with a greater decrease in the brines with the highest NaCl concentration. Up to 49 days, the internal tissue of pickles with 1.3, 3.8, or 7.6% salt concentrations were presumptively positive for L. monocytogenes by the enrichment method, and at 91 days the surfaces of such pickles were still positive for L. monocytogenes. Populations of total aerobes and lactic acid bacteria increased during room temperature storage and decreased gradually during refrigerated storage.


2004 ◽  
Vol 116 (3) ◽  
pp. 338-341 ◽  
Author(s):  
Masahito Kodera ◽  
Yuuji Kajita ◽  
Yoshimitsu Tachi ◽  
Kou Katayama ◽  
Koji Kano ◽  
...  

2015 ◽  
Vol 230 ◽  
pp. 140-143 ◽  
Author(s):  
Tatiana Prikhna ◽  
Orest Ostash ◽  
Tetyana Basyuk ◽  
Andriy Ivasyshyn ◽  
Volodymyr Sverdun ◽  
...  

The mechanical properties and temperature stability in air and hydrogen of the highly dense (ρ=4.27 g/cm3, porosity 1 %) material based on nanolaminated MAX phase Ti3AlC2 (89 % Ti3AlC2, 6 % TiC, 5 % Al2O3) manufactured by hot pressing (at 30 MPa) have been investigated. At room temperature the samplesexhibited microhardness HV = 4.6 GPa (at 5 N), hardness HV50 = 630 MPa (at 50 N ) and HRA=70 (at 600 N), Young modulus was 140 ± 29 GPa, fracture toughness K1C=10.2 MPa·m0.5compression strength 700 MPa and bending strength 500 MPa. After 1000 hours of exposition at 600 °C the oxide film (containing mainly Al2O3 and TiO2) formed on the surface and material demonstrated a higher oxidation resistance than chromium ferrite steels. Due to the surface oxidation the defects self-healing took place and the bending strength of the porous Ti3AlC2 (22% porosity) after exposition for 3 h at 600 oC in air slightly (for 3%) increased as compared to that at 20 oC. Besides, the porous Ti3AlC2 material resisted to high-temperature creep and after being kept in H2 at 600 °C for 3h its bending strength reduced by 5 %.


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