quality control study
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Molecules ◽  
2021 ◽  
Vol 26 (20) ◽  
pp. 6160
Author(s):  
Mahesh Attimarad ◽  
Katharigatta N. Venugopala ◽  
Bandar E. Al-Dhubiab ◽  
Rafea Elamin Elgack Elgorashe ◽  
Sheeba Shafi

Three rapid, accurate, and ecofriendly processed spectrophotometric methods were validated for the concurrent quantification of remogliflozin (RGE) and vildagliptin (VGN) from formulations using water as dilution solvent. The three methods developed were based on the calculation of the peak height of the first derivative absorption spectra at zero-crossing points, the peak amplitude difference at selected wavelengths of the peak and valley of the ratio spectra, and the peak height of the ratio first derivative spectra. All three methods were validated adapting the ICH regulations. Both the analytes showed a worthy linearity in the concentration of 1 to 60 µg/mL and 2 to 90 µg/mL for VGN and RGE, respectively, with an exceptional regression coefficient (r2 ≥ 0.999). The developed methods demonstrated an excellent recovery (98.00% to 102%), a lower percent relative standard deviation, and a relative error (less than ±2%), confirming the specificity, precision, and accuracy of the proposed methods. In addition, validated spectrophotometric methods were commendably employed for the simultaneous determination of VGN and RGE from solutions prepared in the laboratory and the formulation. Hence, these methods can be utilized for the routine quality control study of the pharmaceutical preparations of VGN and RGE in pharmaceutical industries and laboratories. The ecofriendly nature of the anticipated spectrophotometric procedures was confirmed by the evaluation of the greenness profile by a semi-quantitative method and the quantitative and qualitative green analytical procedure index (GAPI) method.


Author(s):  
Hamidreza Masjedi ◽  
Hamed Zamani ◽  
Saman Dalvand ◽  
Mohammad Hossein Zare

Introduction: Generally, the benefits of radiological examinations performed on individuals far outweigh their risks; however, this is not true when the radiographic system fails to work properly. Therefore, to avoid such errors, it is crucial to frequently perform Quality Control (QC) checks in an imaging facility. Material and Methods: A total of 11 highly-referred centers out of 62 radiology rooms located in Yazd province were included in this investigation, and QC tests comprising light/radiation field alignment, the accuracy of kilovoltage and exposure time, reproducibility of kilovoltage, exposure time, and output, and linearity of output against exposure time and milliamperage were performed for each equipment. The light and radiation field alignment test were carried out by a quantitative assessment of digital images of a collimator template (PTW-Freiburg, Germany). The measurements were made by a Barracuda package and a Multi-Purpose Detector (MPD). Results: In terms of the light/radiation field alignment check, unit A failed to satisfy the national regulations. Concerning the timer reproducibility, 64% of the units failed to meet the criteria. All of the devices passed the rest of the checks satisfactorily. Conclusion: This study uncovered that most of the radiology rooms in Yazd province are in an adequate situation based on the QC tests; however, more than half of the units do not satisfy the timer reproducibility criteria. Hence, more supervision needs to be directed at these systems by qualified radiation safety officers who are responsible for the protection of the population against ionization radiation.


2021 ◽  
Vol 1986 (1) ◽  
pp. 012130
Author(s):  
TANG Jianmin ◽  
WU Laijie ◽  
LIU Haijun ◽  
LI Bo ◽  
ZENG Dejun

Author(s):  
Khare Rashmi ◽  
Patwardhan Abhishek ◽  
Patwardhan Ashwini ◽  
Pananchery Jeeja ◽  
Jain Ashish

Ayurveda is the oldest system of medicine. Ayurvedic, herbal and herbo-mineral preparations are used for the treatment of chronic and degenerative diseases with less side-effects. Septipat - 250 Tablet is a compound herbomineral formulation widely used in Ayurvedic clinical practice as natural antibiotics, which has a tendency to kill the bacteria and give health and hygiene. Septipat - 250 Tablet consists of Kanchnar (Bauhinia variegata), Gulvel (Tinospora cordifolia), Shuddha Guggul (Commiphora mukul), Nagakaeshar (Mesua ferrea) and four mineral ingredients Tamra bhasma, Mandur bhasma, Shadgun Kajjali and Saindhav Lavana. The detailed evaluation of this Patented and Properitory Product was studied for the following parameters: physico-chemical, elemental assay and HPLC analysis of the product. The parameters were found to be sufficient and set as reference specification for the Septipat - 250 Tablet quality control study.


Author(s):  
Steven M. Maurer ◽  
Laura Kursawe ◽  
Stefan Rahm ◽  
Julia Prinz ◽  
Annelies S. Zinkernagel ◽  
...  

Abstract Background The skin commensal Cutibacterium avidum has been recognized as an emerging pathogen for periprosthetic joint infections (PJI). One currently assumes that the early occurring PJIs are a consequence of skin commensals contaminating the peri-implant tissue during surgery. We addressed whether standard skin antisepsis with povidone-iodine/alcohol before total hip arthroplasty (THA) is effective to eliminate colonizing bacteria with focus on C. avidum. Methods In a single-center, prospective study, we screened all patients for skin colonizing C. avidum in the groin before THA. Only in the patients positive for C. avidum, we preoperatively repeated skin swabs after the first and third skin antisepsis and antibiotic prophylaxis. We also obtained dermis biopsies for microbiology and fluorescence in situ hybridization (FISH). Results Fifty-one out of 60 patients (85%) were colonized on the skin with various bacteria, in particular with C. avidum in 12 out of 60. Skin antisepsis eliminated C. avidum in eight of ten (20%) colonized patients undergoing THA. Deeper skin (dermis) biopsies were all culture negative, but FISH detected single positive ribosome-rich C. avidum in one case near sweat glands. Conclusion Standard skin antisepsis was not effective to completely eliminate colonizing C. avidum on the skin in the groin of patients undergoing THA. Colonizing with C. avidum might pose an increased risk for PJI when considering a THA. Novel more effective antisepsis strategies are needed. Trial registration No clinical trial


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Francesco Ferrara ◽  
◽  
Luna Gargani ◽  
Carla Contaldi ◽  
Gergely Agoston ◽  
...  

Abstract Purpose This study was a quality-control study of resting and exercise Doppler echocardiography (EDE) variables measured by 19 echocardiography laboratories with proven experience participating in the RIGHT Heart International NETwork. Methods All participating investigators reported the requested variables from ten randomly selected exercise stress tests. Intraclass correlation coefficients (ICC) were calculated to evaluate the inter-observer agreement with the core laboratory. Inter-observer variability of resting and peak exercise tricuspid regurgitation velocity (TRV), right ventricular outflow tract acceleration time (RVOT Act), tricuspid annular plane systolic excursion (TAPSE), tissue Doppler tricuspid lateral annular systolic velocity (S’), right ventricular fractional area change (RV FAC), left ventricular outflow tract velocity time integral (LVOT VTI), mitral inflow pulsed wave Doppler velocity (E), diastolic mitral annular velocity by TDI (e’) and left ventricular ejection fraction (LVEF) were measured. Results The accuracy of 19 investigators for all variables ranged from 99.7 to 100%. ICC was > 0.90 for all observers. Inter-observer variability for resting and exercise variables was for TRV = 3.8 to 2.4%, E = 5.7 to 8.3%, e’ = 6 to 6.5%, RVOT Act = 9.7 to 12, LVOT VTI = 7.4 to 9.6%, S’ = 2.9 to 2.9% and TAPSE = 5.3 to 8%. Moderate inter-observer variability was found for resting and peak exercise RV FAC (15 to 16%). LVEF revealed lower resting and peak exercise variability of 7.6 and 9%. Conclusions When performed in expert centers EDE is a reproducible tool for the assessment of the right heart and the pulmonary circulation.


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