Physicochemical assessment of branded and generic linezolid injection from different pharmaceutical manufacturers

2020 ◽  
Vol 16 ◽  
Author(s):  
Su-hua Zhang ◽  
Shan-shan Wei ◽  
Zhen-yu Zhu ◽  
Ying Chen ◽  
Hua-lin Cai ◽  
...  
Keyword(s):  
High Performance ◽  
Control Method ◽  
Ph Value ◽  
Freezing Point ◽  
Generic Drugs ◽  
Treatment Options ◽  
Related Impurities ◽  
Insoluble Particles ◽  
Significant Difference

Background: Up to date, generic linezolid injections produced by Chinese manufacturers were not widely used in clinic in China. Quality evaluation of linezolid injections produced in China is prerequisite, which has rarely been performed. Objective: This study aimed to evaluate the quality of branded and generic injections from different manufacturers and to provide a basis for the quality control. Methods: In this study, the content of linezolid, related impurities and enantiomer of linezolid were determined by high performance liquid chromatography. The content of glucose was determined by iodine method. The insoluble particles and visible and sub-visible particles were determined by light blockage and lamp test respectively. Osmotic pressure was determined by freezing point depression method. Standard solution control method was used to check the color of the injection. Linezolid injections from different manufacturers were evaluated uniformly. Results: No significant difference was found in the content of linezolid, glucose, related impurities, visible particles, insoluble particles, pH value, and solution color between branded and generic drugs from different manufacturers in China. Conclusion: The quality of samples from different manufacturers is consistent. Although the physicochemical similarity does not guarantee the bioequivalence of studied branded and generic linezolid injections, the results provide references for further bioequivalence study. Generic injections offer more affordable treatment options for patients with infections than expensive branded drugs.

scholarly journals Association of Blood and Urine Parameter Value Change With the Amount of Consumed Water Regime and Sample Sampling in Healthy Individuals

2021 ◽  
Author(s):  
Snezana M Jovicic
Keyword(s):  
Water Intake ◽  
Freezing Point ◽  
Freezing Point Depression ◽  
Sodium Potassium ◽  
Significant Difference ◽  
Urine Biomarker ◽  
Concentration Changes ◽  
The Difference ◽  
And Gender

Abstract Background: Understanding the effect of pre-analytical factors is important for data quality of bio-specimens and health status. The study examines the effect of 9-days fluid intake and 2-time sampling on concentration changes of 7-Urine and 17-Blood variables. Material and Method: SPSS software v23.0 applies to data processing. The group of 23 healthy subjects divide based on water intake and gender. Results: A statistically significant difference(p<0.01) between 1st/2nd sampling is confirmed for Freezing point depression, Sodium, Potassium, Creatinine Urea and Urate in Urine and Urea, Urate, Glucose, Hematocrit, Thrombocyte in Blood. The difference between water intake after 1st sampling is confirmed (p<0.01) for Freezing point depression, Sodium, Urate and(p<0.05) for Potassium(p<0.05), Chloride(p<0.05), Creatinine(p<0.05), Urate, Urea in Urine and Potassium(p<0.01) and Chloride(p<0.05) in Blood. Difference between gender exists for Urea(p<0.05) in Urine after 2nd sampling and Urate(P<0.01), Glucose(p<0.01/0.05), Ht(p<0.01/0.05) after 1st and 2nd sampling and MCHC(p<0.01) after 2nd sampling in Blood samples.Conclusion: Water intake increases blood and urine biomarker range after sampling.

scholarly journals PENGARUH PERBEDAAN BAHAN PENYAMAK TERHADAP KUALITAS KULIT IKAN PARI MONDOL (Himantura gerrardi) TERSAMAK The Effect of Different Tanning Materials towards Leather Quality of Tanned Mondol Stingray (Himantura gerrardi)

2016 ◽  
Vol 11 (2) ◽  
pp. 140
Author(s):  
Tika Kusmaryanti ◽  
Ratna Ibrahim ◽  
Putut Har Riyadi
Keyword(s):  
Tensile Strength ◽  
Moisture Content ◽  
Ph Value ◽  
Block Design ◽  
Shrinkage Temperature ◽  
Quality Requirements ◽  
Tear Strength ◽  
Randomized Block Design ◽  
Significant Difference

ABSTRAK   Usaha penyamakan kulit ikan Pari umumnya dilakukan oleh usaha kecil menengah dan hanya menggunakan metode aldehid dengan bahan samak formalin, Selain itu juga belum diketahui kualitas kulit ikan Pari Mondol tersamak yang menggunakan bahan samak krom. Penelitian ini bertujuan untuk mengetahui pengaruh perbedaan penggunaan jenis bahan penyamak terhadap kualitas fisik dan kimiawi kulit ikan Pari Mondol tersamak. Materi penelitian berupa kulit ikan Pari Mondol (Himantura gerrardi) dan bahan samak. Penelitian dilakukan dengan metode eksperimental laboratoris. Rancangan percobaan yang digunakan adalah Rancangan Acak Kelompok dengan perlakuan bahan samak yang berbeda, yaitu formalin, krom, dan kombinasi. Masing-masing perlakuan diulang tiga kali. Variabel mutu yang diamati adalah kekuatan tarik, kemuluran, kekuatan sobek, ketebalan, suhu kerut, ketahanan bengkuk (bengkok), pH dan kadar air. Data dianalisis menggunakan ANOVA dan perbedaan diantara perlakuan diuji dengan Uji Tukey. Hasil penelitian menunjukkan bahwa perbedaan bahan penyamak menyebabkan pengaruh nyata terhadap nilai kekuatan tarik, kekuatan sobek dan ketebalan tetapi tidak memberikan pengaruh nyata terhadap nilai pH, kadar air dan ketahanan bengkuk. Produk yang terbaik yaitu kulit ikan Pari Mondol yang disamak dengan bahan samak kombinasi antara krom dan mimosa, yang sebagian persyaratan mutunya sudah memenuhi persyaratan mutu kulit ikan Pari tersamak menurut SNI 06-6121-1999.   Kata kunci: Kualitas, kulit Ikan Pari, penyamak     ABSTRACT  Meanwhile the quality of Stingray tanned leather which using chrome tannin materials was not yet known. This research aims to determine the effect of different types used tannin materials towards physical and chemical quality of Stingray leather quality. The materials used in this research isStingray (Himantura gerrardi) skin and tannin materials. The study was conducted with laboratory experimental method. The experiments was designed according to the Randomized Block Design with different tanning materials (formalin, chrome, and chrome-combination). Each treatment was done with in triplicate. The quality variables that measured were tensile strength, elongation, tear strength, thickness, shrinkage temperature, bent resistance, pH and moisture content. Data were analyzed using Analysis of Variance. To find the difference between treatments, the data were tested with Honestly Significant Difference Test . The results showed that various of tannin materials gave significant effects to the values of tensile strength, tear strength and thickness however there was not any significant effect on bent resistance, moisture content and pH value. The best product were Stingray tanned leather with chrome-combination tannin material, which partially quality requirements has been comply with Stingray tanned leather quality requirements according to SNI. Keywords: Quality, stingray skin, tanning

scholarly journals Study on Optimization of Yeast Level and Duration for Aerobic and Anaerobic Fermentation for Production of Jack Fruit (Artocarpus heterophyllus L.) Wine

2020 ◽  
pp. 12-19
Author(s):  
S. K. Anil ◽  
Praveen Gidagiri ◽  
R. Hamsa ◽  
Praveen Jholgikar
Keyword(s):  
Ph Value ◽  
Anaerobic Fermentation ◽  
Content Increase ◽  
Alcohol Content ◽  
Randomized Design ◽  
Significant Difference ◽  
Cold Condition ◽  
Completely Randomized Design ◽  
Aerobic And Anaerobic

The present investigation on Optimization of yeast level and duration for aerobic and anaerobic fermentationfor production of jack fruit (Artocarpus heterophllyus L.) wine was carried out in the department of Post Harvest Technology, Kittur Rani Channamma College of Horticulture (University of Horticultural Sciences, Bagalkot), Arabhavi, during the year 2010-2011. It consisting of different treatments viz T1 –20 g of yeast for 100 Kg of must+24 hrs aerobic and 7 days anaerobic fermentation, T2-30 g of yeast for 100 Kg of must+24 hrs aerobic and 7 days anaerobic fermentation, T3–20 g of yeast for 100 Kg of must+24 hrs aerobic and 14 days anaerobic fermentation, T4 –30 g of yeast for 100 Kg of must+24 hrs aerobic and 14 days anaerobic fermentation, T5 –20 g of yeast for 100 Kg of must+48 hrs aerobic and 7 days anaerobic fermentation, T6 –30 g of yeast for 100 Kg of must+48 hrs aerobic and 7 days anaerobic fermentation, T7 –20 g of yeast for 100 Kg of must+48 hrs aerobic and 14 days anaerobic fermentation and T8 –30 g of yeast for 100 Kg of must+48 hrs aerobic and 14 days anaerobic fermentation. The experiment was laid out in a completely randomized design with three replications. The main objective was to standardize the optimum yeast level and duration required for aerobic and anaerobic fermentation and also to study various biochemical and organoleptic quality of wine recorded at regular interval during the storage of wine. The highest TSS was maintained in treatment T1 (10.47) and T4 (10.47) in cold condition and in ambient condition T1 (10.43) followed by T2 (10.35) shows highest TSS. The pH value increases from 3.36 (fresh wine) to 3.89 (6 MAS in cold) and 3.84 (6 MAS in ambient) and acidity will decrease from 0.59 to 0.49 (Cold) and 0.52 (ambient). Alcohol content increase from 7.46 to 8.12 percent (Cold) and 8.04 (Ambient). Tannin per cent were showed non significant difference and decreasing trend can be seemed over period of aging, T8 (30 g of yeast + 48 hrs aerobic and 14 days of anaerobic fermentation) observe the highest per cent of tannins throughout the investigation.

scholarly journals Effect of different levels of water on qualitative characteristics of Lassi prepared from reconstituted milk

2017 ◽  
Vol 45 (3) ◽  
pp. 46-51 ◽  
Author(s):  
FT Zohra ◽  
MN Islam ◽  
MSR Siddiki ◽  
MR Habib ◽  
S Afrin
Keyword(s):  
Ph Value ◽  
Starter Culture ◽  
Research Work ◽  
Score Card ◽  
Significant Difference ◽  
Added Water ◽  
Physical Tests ◽  
Reconstituted Milk ◽  
Different Levels

Present research work was designed to develop lassi from reconstituted milk using different levels of water. For this purpose, dahi was prepared from reconstituted milk using traditional starter culture. Four different types of lassi were prepared by mixing dahi with 15, 20, 25 and 30% water and sugar level in all samples were 20%. The quality of lassi from reconstituted milk was evaluated by a panel of expert judges by different physical tests using a score card. There was non-significant difference (p>0.05) among the overall physical score of lassi samples. Result revealed that the highest overall score was recorded in 20% added water lassi sample whereas the lowest score was found in 30% added water lassi sample. In chemical analysis, significant differences (p<0.01) existed among the total solids, carbohydrate, fat, protein, moisture content and pH value but non-significant differences (p>0.05) were seen for ash content and acidity percentage. The total bacteria, coliform, yeast and mold in all samples did not exceed the legal standard. From the findings of this study, it might be concluded that lassi could be prepared successfully from reconstituted and mixing reconstituted milk dahi with 20% water along with 20% sugar will produce better quality lassi.Bang. J. Anim. Sci. 2016. 45 (3): 46-51

scholarly journals INVESTIGATIONS ON THE GEOMETRIC QUALITY OF CAMERAS FOR UAV APPLICATIONS USING THE HIGH PRECISION UAV TEST FIELD ZOLLERN COLLIERY

2019 ◽  
Vol XLII-2/W13 ◽  
pp. 531-538 ◽  
Author(s):  
H.-J. Przybilla ◽  
M. Gerke ◽  
I. Dikhoff ◽  
Y. Ghassoun
Keyword(s):  
High Performance ◽  
Cost Effective ◽  
Test Field ◽  
Camera System ◽  
Software Products ◽  
Significant Difference ◽  
Effective System ◽  
Geometric Quality ◽  
Definition Of

<p><strong>Abstract.</strong> The geodetic-photogrammetric test field at the industrial monument Zollern colliery in Dortmund offers a scenario for carrying out geometric and radiometric tests of UAV systems. The foundation for this builds a geodetic precision network (position and height accuracy approx. 2&amp;thinsp;mm) with a total of 45 ground control points, distributed over an area of approx. 7 hectares. Within the scope of a campaign carried out in autumn 2017, various UAV sensor systems were tested under comparable conditions. Within this paper geometric investigations of two current DJI cameras, Zenmuse X4S (20 Mpix) and X5S (20.8 Mpix), as well as a Phase One IXU 1000 (100 Mpix) are presented. While the Zenmuse cameras reflect the current state of development of the manufacturer DJI, the medium format camera system from Phase One is primarily settled in the classic aerial segment. However, the desire for increased measurement accuracy (e. g. for engineering applications) also makes such a high-performance sensor interesting for UAV applications.<br />In addition to the configuration of the test field, the system comparison requires identical parameters for flight planning, in particular image overlapping, a complete cross flight configuration at different flight altitudes and the definition of a uniform ground resolution (GSD&amp;thinsp;=&amp;thinsp;14&amp;thinsp;mm).</p><p>The investigations show clear differences in the achievable quality of the cameras. Though the high-priced Phase One system shows the best results, the most cost-effective system, the Zenmuse X4S, delivers only slightly worse results. In contrast, the Zenmuse X5S performs significantly worse than the other systems, mainly resulting from the mechanically unstable camera concept with interchangeable lenses. Finally, the comparison of the software products Pix4D Pix4Dmapper, Inpho UASMaster by Trimble and Agisoft PhotoScan partly shows significant differences in the results of image orientation. In particular in settings with sparse GCP usage the results vary considerably, indicating different strategies on how the residuals are distributed and the datum is defined, mostly Pix4Dmapper outperforms the others. In better GCP configurations there is no significant difference between Pix4mapper and Agisoft PhotoScan, while UASMaster does never deliver the best results.</p>

scholarly journals The effect of powdered spices formula on antioxidant activity and sensory quality of solid brem

Food Research ◽  
2021 ◽  
Vol 5 (S2) ◽  
pp. 120-127
Author(s):  
N.V. Maramy ◽  
B.R. Handayani ◽  
M.A. Zaini
Keyword(s):  
Antioxidant Activity ◽  
Water Activity ◽  
Sensory Quality ◽  
Ph Value ◽  
Block Design ◽  
Polynomial Method ◽  
Significance Level ◽  
Light Yellow ◽  
Significant Difference

Solid brem is one of Indonesian traditional food. The low level of antioxidant content might be increased by adding powdered spice formula which is rich in phenolic compounds. The objective of this study was to determine the effect of powdered spices formula on antioxidant activity and sensory quality of solid brem. The formulation of powdered spices was ginger, turmeric, cloves, nutmeg, pepper, and cinnamon in a ratio of 3: 1: 1: 1: 1: 0.5. Randomized Complete Block Design (RCBD) with six treatments of adding powdered spices formula (0, 1, 2, 3, 4, and 5%) and three replications were used as the method. The data were analyzed by analysis of variance (ANOVA) at a 5% significance level using Co-Stat software and tested further by Orthogonal Polynomial Method (OPM) or using Honestly Significant Difference (HSD). The result showed that adding powdered spices formula on solid brem had a significant different effect on antioxidant activity, water activity, pH value, physical quality (texture and color), and sensory quality (hedonic) on color, taste, texture, and melting in the mouth. The addition of 4% of the spices formula is recommended to produce the best quality of solid brem with the following characteristic: 80.51% of antioxidant activity, 15.71 mg GAE/g of material total phenol, 40.90% Brix of total dissolved solids, 0.55 water activity (Aw), 3.44 pH value, 9.08 N texture value (physical), and 84.68 oHue color value (physical). The product had light yellow; slightly spicy, solid and rather smooth texture, and melting in the mouth. The high content of antioxidant activity in the product proved the potential of using powdered spices in improving the antioxidant activity of solid brem.

scholarly journals Lessons learned from developing online training for humanitarians

2017 ◽  
pp. 419-432 ◽  
Keyword(s):  
Online Learning ◽  
High Performance ◽  
Online Training ◽  
Lessons Learned ◽  
Red Cross ◽  
Significant Difference ◽  
Practical Guidelines ◽  
Training Programmes ◽  
Stock Of Knowledge

A comprehensive online learning programme with more than 200 courses was built by the International Federation of Red Cross and Red Crescent Societies between starting with 2009 and 2015, offering development opportunities to the Red Cross and Red Crescent (RCRC) volunteers and staff to broaden their understanding, to strengthen their organisations, and to be better prepared in providing humanitarian aid. While it is difficult to say to what extent factors such as training, job mentoring, and induction programmes contribute to job performance and to an organisation’s efficiency, it is certain that staff and volunteers willing to undertake courses are more open to transformative and creative approaches, more prepared to tackle with new challenges, more likely to have a stock of knowledge and competencies broader than their own specialisation. Learning and “knowing to learn” are conditions for competitiveness and high performance. Over time, generally speaking, implementation of training as a priority personnel policy proved to have the most significant effects on productivity growth, therefore, efforts towards building a learning culture and delivering quality (online) learning are key for developing organisations, their staff, and the quality of services provided. An online training would make a significant difference in learners’ behaviour if it follows several practical guidelines in development, accompanied by thorough checklists to ensure relevance, consistency, alignment and to assist training programmes’ lifecycle.

scholarly journals Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics

Antibiotics ◽  
2021 ◽  
Vol 10 (9) ◽  
pp. 1096
Author(s):  
Ping Yang ◽  
Shigeru Fujimura ◽  
Yawei Du ◽  
Bei Zhang ◽  
Li Yang ◽  
...  
Keyword(s):  
Generic Drugs ◽  
Particle Morphology ◽  
Antimicrobial Activities ◽  
Brand Name ◽  
Residual Solvent ◽  
Insoluble Particles ◽  
Significant Difference ◽  
Drug Manufacturing ◽  
Distribution Uniformity ◽  
Pharmaceutical Properties

This study aimed to provide comparative information of pharmaceutical properties, including particle morphology and distribution uniformity, solubility, presence of residual solvent and insoluble particles, and antimicrobial activities, between brand-name meropenem (Mepem®, BNM) and its six generic products (GPs A-F) marketed in China. Particles of GP-A and -C in dry powder had similar diameters of BNM, while other GPs were larger. Only BNM and GP-A were completely dissolved within 100 s in the lab condition. No insoluble particles >25 μm in diameter were detected in BNM and GP-E. Regarding stability of GPs solutions evaluated by concentration of open-ring metabolites at 6 h and 8 h, BNM showed the lowest open-ringed metabolite concentrates. Residual solvent of acetone detected in one GP showed the maximum value, while ethanol and ethyl acetate were detected both in product E and product F. The concordance rates (%) of minimum inhibitory concentration (MIC) of each generic compared to BNM were 89.5, 85, 87.5, 88, 88.5, and 86.5, respectively, although no significant difference was reached in MIC. Pharmaceutical characteristic differences between the BNM and GPs identified in this study could provide insights into understanding the deviations in the drug manufacturing processes of generic drugs.

scholarly journals The effect of leaf area to yield ratio on secondary metabolites in grapes and wines of Vitis vinifera L. cv. Sauvignon Blanc

OENO One ◽  
2013 ◽  
Vol 47 (2) ◽  
pp. 83 ◽  
Author(s):  
Katja Šuklje ◽  
Helena Baša Česnik ◽  
Lucija Janeš ◽  
Veronika Kmecl ◽  
Andreja Vanzo ◽  
...  
Keyword(s):  
Leaf Area ◽  
Ph Value ◽  
Limit Of Detection ◽  
Yield Ratio ◽  
Soluble Solids ◽  
Sauvignon Blanc ◽  
Total Soluble Solids ◽  
Significant Difference ◽  
Sensorial Quality

<p style="text-align: justify;"><strong>Aim</strong>: To investigate the effect of reducing leaf area by shoot hedging in combination with bunch thinning on metabolite concentration and sensorial quality of Sauvignon blanc grapes and wines.</p><p style="text-align: justify;"><strong>Methods and results</strong>: Four vine treatments were conducted: shoot hedging/bunch thinning (SH/BT), shoot hedging/no bunch thinning (SH/NBT), full canopy/bunch thinning (FC/BT) and full canopy/no bunch thinning (FC/NBT). Shoot hedging delayed total soluble solids accumulation at the beginning of the grape maturation in SH/BT and SH/NBT treatments. At harvest there were no significant differences in the concentration of hydroxycinnamoyl tartaric acids, glutathione, total soluble solids, titratable acidity and pH value in grape juice between all treatments and methoxypyrazines were below the limit of detection. Lutein concentration in grape berry was higher in treatments without bunch thinning, while there was no significant difference in the concentration of β-carotene and neoxanthin. The highest leaf area to yield ratio (FC/BT) resulted in higher concentration of glutathione in must and higher concentration of thiols in Sauvignon blanc wines. Upon sensory evaluation, the FC/BT wine was best scored for overall quality and heavier tropical aroma, whereas the FC/NBT wine was best scored for fresh tropical aroma and second best for overall quality.</p><p style="text-align: justify;"><strong>Conclusion</strong>: Leaf area to yield ratio impacted berry ripening kinetics, grape and wine metabolite composition, and sensorial properties of Sauvignon blanc wine.</p><p style="text-align: justify;"><strong>Significance and impact of the study</strong>: The study showed that the highest leaf area to yield ratio resulted in the best overall sensorial quality of wine.</p>

scholarly journals Chemical Fingerprinting and Quantitative Analysis of Cortex Moutan From Different Tree Peony Cultivars Using HPLC-ESI/MS

2020 ◽  
Vol 15 (11) ◽  
pp. 1934578X2097351
Author(s):  
Guodong Yang ◽  
Chunhui Zhang ◽  
Peng Li ◽  
Yan Qiu ◽  
Faming Dong
Keyword(s):  
Quantitative Analysis ◽  
High Performance ◽  
Control Method ◽  
Chemical Components ◽  
Ionization Mass ◽  
Tree Peony ◽  
Cortex Moutan ◽  
Significant Difference ◽  
Chemical Fingerprinting ◽  
The Relationship

To evaluate the relationship between tree peony cultivars and the quality consistency of Cortex Moutan, a sensitive, reliable, and validated method based on high-performance liquid chromatography-electrospray ionization/mass spectrometry was developed for the quantitative analysis of paeonol and chemical fingerprinting of Cortex Moutan. Results from quantitative analysis showed that the content of paeonol in Paeonia ostii “Feng Dan” was the highest (24.51 ± 0.83 mg/g), followed by Paeonia suffruticosa “Luoyang Hong” (14.29 ± 0.76 mg/g), P. suffruticosa “Taiping Hong” (13.99±1.13 mg/g), and P. suffruticosa “Zhaofen” (13.08±0.85 mg/g). Paeonia ostii “Luoyang Feng Dan” was found to have the lowest content (8.76±0.46 mg/g) of paeonol. In qualitative analysis, 5 tree peony cultivars collected from different plantations in China were used to establish the fingerprint. For the fingerprint analysis, 17 characteristic peaks were used to evaluate similarities among tree peony cultivars, and they were found to show similarities. In short, the results of quantitative and qualitative analyses suggested that there was no significant difference in the chemical composition of Cortex Moutan from different tree peony varieties; however, there were significant differences in the levels of chemical components. The method developed in this study provides an important reference to establish a quality control method for other related traditional Chinese medicinal preparations.

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