scholarly journals SHELF LIFE PREDICTION OF DIAGNOSTIC FLUORESCENT TULAREMIA DRY IMMUNOGLOBULINS

Author(s):  
O.L. Startseva ◽  
S.A. Kurcheva

We described the results of studying the stability of the main indicators of medical product quality for in vitro diagnostics - diagnostic fluorescent tularemia dry immunoglobulins RIF-Tul-StavNIPCHI, developed on the basis of Stavropol Anti-Plague Institute of Rospotrebnadzor to justify the shelf life and recommended storage conditions when used on a real scale time and accelerated research methods. At the same time, one of the main criteria for the study of stability is its study during sample storage not only in the primary packaging of an industrial output, but also after the first opening of the package, during the use period of the reconstituted preparation. On the basis of data obtained in both long-term and accelerated trials, a shelf life of three years is recommended. It was experimentally proved that during this period of time, the quality indicators of the drug remain at a level one that complies with the requirements of technical and operational documentation. In the course of application the recovered product demonstrates stability of its biological and physical-and-chemical properties within 5 days at a storage temperature of 2 to 8°С.

2018 ◽  
Vol 20 (92) ◽  
pp. 29-33
Author(s):  
R. M. Sachuk ◽  
O. A. Katsaraba

For standardization, quality control, study of stability and establishment of storage conditions and terms of use, complex preclinical trials of the new development of PE “Biopharm” and the Experimental Station of Epizootology IVM NAAN – aerosol preparation “Yodozol” have been carried out. The methods of evaluation of a medicinal product applied to aerosols are used, which include: determination of changes in appearance, inspection of packaging for leakproofness, measurement of the percentage of contents of the package, the establishment of qualitative and quantitative indicators of active substances, and also the study of microbiological purity of the product. “Yodozol” is a light yellow liquid, 1 ml of which contains 5 mg of iodine and 10 mg of potassium iodide. The drug is used for the prevention and treatment of postnatal intrauterine infections in cows, pigs, sheep and goats (endometritis, pyrometers, cervicitis, vaginitis, delayed digestion caused by microorganisms sensitive to iodine), after obstetrics aid, cesarean section and postpartum sanitation of the uterus. The drug has antimicrobial, anti-inflammatory and analgesic effects, improves the proliferative processes of the genital organs, reduces the time for recovery of animals. The drug is used according to the guidelines, after its production livestock is used without restrictions. The shelf-life, which is the result of the test of the dasg according to the «stability» indicator, has been determined, which was performed under long-term storage in a place protected from light at a temperature range from + 5 ± 2 °С to + 25 ± 2 °С. The studies conducted after 6, 12, 24 and 30 months showed complete compliance of the quality indices with the declared standards when stored for 24 months in the temperature corridor from + 5 °C to + 20 °C. With an increase in storage temperature to + 25 °C or more, a slight quantitative decrease in the concentration of antimicrobial components occurred. In addition, with long-term storage of drugs, release of the contents from the cylinder became uneven and foam acquired a shade less than the saturation rate, increased microbiological contamination. Thus, according to the results of the study, the established shelf life of the preparation is 2 years at the recommended storage temperature from +5 to           +20 °С. All studies conducted on the stability of the aerosol intrauterine drug “Yodozol” were included in the registration materials of the medicinal product.


Soil Research ◽  
2017 ◽  
Vol 55 (2) ◽  
pp. 182 ◽  
Author(s):  
Mohsen Jalali ◽  
Mahdi Jalali

Little information is available on phosphorus (P) solubility in long-term cultivated calcareous soils. Improved characterisation of P-containing minerals and soil P species in calcareous soils leads to better management of crop production, water quality and soil quality. In this study, we investigated the solubility relationships of P for 20 surface-soil samples from Hamedan, western Iran, with a wide range of physical and chemical properties. Two equilibration times (0.5 and 168h) were used to evaluate the effect of equilibration times on P activities. We observed up to 67% decrease in mean P concentration when equilibration time was increased from 0.5 to 168h. Solubility diagrams support the stability of hydroxyapatite with 0.5h equilibration and hydroxyapatite and β-tricalcium phosphate with 168h equilibration. Geochemical modelling predicted that dicalcium phosphate, dicalcium phosphate dihydrate and magnesium-P minerals would be unstable and thus would gradually dissolve and supply P in solution in these calcareous soils. The information obtained can be used to predict the behaviour of P and its availability for agricultural crops in calcareous soils.


2015 ◽  
Vol 68 (2) ◽  
pp. 7703-7712 ◽  
Author(s):  
Blanca Cecilia Salazar Alzate ◽  
Misael Cortés Rodríguez ◽  
Olga Inés Montoya Campuzano

The goal of this research project was to assess the quality of sugarcane powder, during storage, that had been biofortified with kefir grains (SP+KG). The powder was obtained by spray drying (SD) sugarcane concentrate that was previously fermented with kefir grains (KG). Maltodextrin, 20% w/w, was used as a drying additive, and high viability of the microbial consortium (lactobacilli, lactococci and yeast) was always sought in order to obtain a functional food enriched with probiotic microorganisms, which facilitate storage and consumption. The product was packed, both vacuum (V) and non-vacuum (WV), and stored at 10, 20 and 30°C for 180 days. The results showed significant differences (p < 0.05) in the survival rate of lactobacilli and lactococci for the time, temperature and packaging type (PT) factors; however, the yeast showed no significant differences for the PT factor. For the survival of yeast, lactococci and lactobacilli, the best temperature was 10°C and the best packaging type was V. The survival rates reached with these conditions were 62.82% (yeast), 81.22% (lactococci) and 87.82% (lactobacilli). In addition, the levels attained in terms of physical and chemical properties defined the quality specifications of the product. The sugarcane matrix is an effective vehicle of components with physiological activity such as the microorganisms present in kefir. This qualifies the product as a potential functional food.


Polymers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 2998
Author(s):  
Mohammed Nadeem Bijle ◽  
Manikandan Ekambaram ◽  
Edward Lo ◽  
Cynthia Yiu

The in vitro study objectives were to investigate the effect of arginine (Arg) incorporation in a 5% sodium fluoride (NaF) varnish on its physical and chemical properties including F/Arg release. Six experimental formulations were prepared with L-arginine (L-Arg) and L-arginine monohydrochloride at 2%, 4%, and 8% w/v in a 5% NaF varnish, which served as a control. The varnishes were subjected to assessments for adhesion, viscosity, and NaF extraction. Molecular dynamics were simulated to identify post-dynamics total energy for NaF=Arg/Arg>NaF/Arg<NaF concentrations. The Arg/F varnish release profiles were determined in polyacrylic lactate buffer (pH-4.5; 7 days) and artificial saliva (pH-7; 1 h, 24 h, and 12 weeks). Incorporation of L-Arg in NaF varnish significantly influences physical properties ameliorating retention (p < 0.001). L-Arg in NaF varnish institutes the Arg-F complex. Molecular dynamics suggests that NaF>Arg concentration denotes the stabilized environment compared to NaF<Arg (p < 0.001). The 2% Arg-NaF exhibits periodic perennial Arg/F release and shows significantly higher integrated mean F release than NaF (p < 0.001). Incorporating 2% L-arginine in 5% NaF varnish improves its physical properties and renders a stable matrix with enduring higher F/Arg release than control.


2015 ◽  
Vol 63 (1) ◽  
pp. 47-54 ◽  
Author(s):  
Karsten Schacht ◽  
Bernd Marschner

Abstract The use of treated wastewater (TWW) for agricultural irrigation becomes increasingly important in water stressed regions like the Middle East for substituting fresh water (FW) resources. Due to elevated salt concentrations and organic compounds in TWW this practice has potential adverse effects on soil quality, such as the reduction of hydraulic conductivity (HC) and soil aggregate stability (SAS). To assess the impact of TWW irrigation in comparison to FW irrigation on HC, in-situ infiltration measurements using mini disk infiltrometer were deployed in four different long-term experimental orchard test sites in Israel. Topsoil samples (0-10 cm) were collected for analyzing SAS and determination of selected soil chemical and physical characteristics. The mean HC values decreased at all TWW sites by 42.9% up to 50.8% compared to FW sites. The SAS was 11.3% to 32.4% lower at all TWW sites. Soil electrical conductivity (EC) and exchangeable sodium percentage (ESP) were generally higher at TWW sites. These results indicate the use of TWW for irrigation is a viable, but potentially deleterious option, as it influences soil physical and chemical properties.


2012 ◽  
Vol 200 ◽  
pp. 466-469
Author(s):  
Wen Li Dong ◽  
Xue Gong ◽  
Jing Dong ◽  
Ling Jin ◽  
Yu Xiang Wei

The changing patterns of filbert peroxide value through the determination of different storage temperature conditions,research the dynamics characteristics of oxidative rancidity of filbert. By regression analysis base on the storage time and the logarithm of peroxide value,it concluded the grease oxidation reaction first-order kinetic equation of filbert.Using Arrhenius equation and Q10 model for 5 ~ 35 °C temperature within the shelf life of any temperature prediction model.


1970 ◽  
Vol 44 (2) ◽  
pp. 147-156
Author(s):  
Tamanna Sultana ◽  
GP Savage ◽  
NG Porter ◽  
DL McNeil ◽  
JR Sedcole

Isothiocyanates (ITCs) contained in purees extracted from wasabi (Wasabia japonica (Miq) Matsum) can be used to manufacture a range of interesting spicy foods. In New Zealand, local manufacturers are showing interest in producing various forms of processed wasabi based sauces. However, isothiocyanates have been shown to degrade quickly in some situations. Therefore, in this study, the stability of allyl ITC was investigated in three wasabi flavoured products stored at four different temperatures (4, 10, 20 and 30°C) for 22 weeks. Two creamy (mayonnaise and tartare) sauces and a non-creamy sauce were prepared from an original recipe and flavoured with a known volume of "wasabi oil". Two types of pouches (clear and metallic plastic) were used to store each product and allyl ITC content was measured in the stored sauces at two week intervals. The initial level of allyl ITC found in mayonnaise, tartare and smoky tomato sauces were 415.3, 411.4 and 144.7 mg/ kg respectively, prior to storage. Temperature showed a strong influence in reducing allyl ITC (P=0.005 to <0.001) but no significant effect was identified for the two types of packets used. The non-creamy smoky tomato sauce was very unstable at 10°C or higher temperatures and the allyl ITC contents reduced rapidly with increasing storage temperatures. For instance, at 30°C, a 66% loss occurred by week 2 and a 90% loss occurred by week 6 in the smoky tomato sauce. However, mayonnaise and tartare sauces had a shelf life of 8 to 9 weeks with only a marginal reduction in allyl ITC (2% overall) at all the stored temperatures (4-30°C). These creamy sauces were characterized by a sudden fall in 10 weeks ending in a 69-70% loss of allyl ITC at 22 weeks. No microbial growth occurred in any of the sauces stored at any of the temperatures during the course of this storage experiment though very small change of colour was noticed for the sauces when stored at 30°C. Keywords: Bangladesh J. Sci. Ind. Res. 44(2), 147-156, 2009DOI: 10.3329/bjsir.v44i2.3665Bangladesh J. Sci. Ind. Res. 44(2), 147-156, 2009


2021 ◽  
Vol 15 (1) ◽  
pp. 2
Author(s):  
Cristina Martín-Sabroso ◽  
Mario Alonso-González ◽  
Ana Fernández-Carballido ◽  
Juan Aparicio-Blanco ◽  
Damián Córdoba-Díaz ◽  
...  

Accumulation of cystine crystals in the cornea of patients suffering from cystinosis is considered pathognomonic and can lead to severe ocular complications. Cysteamine eye drop compounded formulations, commonly prepared by hospital pharmacy services, are meant to diminish the build-up of corneal cystine crystals. The objective of this work was to analyze whether the shelf life proposed for six formulations prepared following different protocols used in hospital pharmacies is adequate to guarantee the quality and efficacy of cysteamine eye drops. The long-term and in-use stabilities of these preparations were studied using different parameters: content of cysteamine and its main degradation product cystamine; appearance, color and odor; pH and viscosity; and microbiological analysis. The results obtained show that degradation of cysteamine was between 20% and 50% after one month of storage in the long-term stability study and between 35% and 60% in the in-use study. These data confirm that cysteamine is a very unstable molecule in aqueous solution, the presence of oxygen being the main degradation factor. Saturation with nitrogen gas of the solutions offers a means of reducing cysteamine degradation. Overall, all the formulae studied presented high instability at the end of their shelf life, suggesting that their clinical efficacy might be dramatically compromised.


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