Bulk Solution Assay Test Procedure Development and validation for Esomeprazole Sodium Injection 40mg as a CPP

2021 ◽  
pp. 177-192
Author(s):  
Santoshkumar R. Mulik ◽  
Rishikesh S. Bachhav
Keyword(s):  
Potentiometric Titration ◽  
Method Development ◽  
Uv Spectroscopy ◽  
Test Procedure ◽  
Processing Parameters ◽  
Test Method ◽  
Bulk Solution ◽  
Uv Spectrometry ◽  
Delayed Release ◽  
It Impact

Assay analytical test procedure at the Bulk-Solution stage for Esomeprazole Sodium Injection 40mgas a Critical Processing Parameters during manufacturing developed and validated. As per current available literature and the references, Esomeprazole active substance is available in market in the five forms, i.e. Esomeprazole as Plain [Tablet]; Esomeprazole Magnesium Trihydrate [Tablet, Capsule Delayed Release]; Esomeprazole Potassium [Tablet and Capsule]; Esomeprazole Strontium [Capsule Delayed Release] and Esomeprazole Sodium [Injectable].Assay test procedure for Active and other dosage forms [Tablet, Capsule] were available based on either Potentiometric Titration or HPLC basis. Product Esomeprazole Sodium Injection 40mg is not available in official pharmacopeia. As per available reference and literature assay test method for intermediate testing and finished product is based on HPLC. Intermediate testing [In-Process Testing] required as Critical Process Parameters [CPP] to ensure the quality i.e. appropriate bulk-solution purity, before to proceed for filtration and filling of Bulk-solution in unit dosage form [Vials]. To test the bulk solution purity approximate 5-6 hours required by HPLC. Which leads to hold the Bulk solution, further it impact and may risk to Bio-Burden of bulk solution. Also it impact and reduce the productivity of line by 5-6 hours. HPLC testing required special skilled manpower and cost. Considering all above concerns Study carried for test method development based on UV-Spectroscopy, HPLC and potentiometric titration. Based on method validation performed for UV-Spectrometry, HPLC and potentiometric titration; Test procedure developed and validated based on UV-Spectrometry is found Simple, Accurate, Precise, Economical and Rapid to save time and cost with increase in productivity as a Critical Processing Parameters for Esomeprazole Sodium Injection 40mgat the Bulk-Solution stage during manufacturing.

Multiple loading method for field testing drilled piers

1985 ◽  
Vol 22 (4) ◽  
pp. 592-599
Author(s):  
R. G. Horvath
Keyword(s):  
Test Procedure ◽  
Load Cell ◽  
Load Test ◽  
Test Method ◽  
Single Test ◽  
Loading Test ◽  
Shaft Resistance ◽  
Loading Method ◽  
Multiple Loading ◽  
Base Load

A multiple loading testing method is suggested, which permits testing a single drilled pier foundation under three different conditions of load support. The pier may be tested under conditions of combined shaft and end-bearing resistance, end-bearing resistance only, and shaft resistance only. The advantages of this multiple loading test method include observation of the load-transfer and displacement behaviours of the pier under these three different support conditions and verification of the values obtained for the components of load support, i.e., shaft and end-bearing resistance, all from a single test pier.A special base load cell capable of performing a different function during each cycle of loading is required. A suitable load cell, consisting of a series of Freyssi flatjacks, and the method of operation are described.A multiple loading test procedure was used successfully as part of a field investigation program on full-scale pier sockets in weak shale. Data on the load-displacement behaviour of the pier tested using the multiple loading method are reported. Information concerning piers tested using conventional single loading methods are provided for comparison.The multiple loading test results were in good agreement with results obtained from conventional testing methods. Thus the multiple loading test method provides an economical means of obtaining a large amount of design information for drilled pier foundation systems, using a single test pier. Key words: field load test, multiple loading, drilled piers and caissons, shaft resistance, end-bearing resistance, combined shaft and end-bearing resistances, base load cell, shale.

scholarly journals Automatic measurement and characterization of the dynamic properties of tethered membrane wings

2019 ◽  
Vol 4 (1) ◽  
pp. 41-55 ◽  
Author(s):  
Jan Hummel ◽  
Dietmar Göhlich ◽  
Roland Schmehl
Keyword(s):  
Dynamic Properties ◽  
Test Procedure ◽  
Control Unit ◽  
Automatic Measurement ◽  
Simulation Models ◽  
Test Method ◽  
Subsequent Work ◽  
Aerodynamic Parameter ◽  
Mean Values

Abstract. We have developed a tow test setup for the reproducible measurement of the dynamic properties of different types of tethered membrane wings. The test procedure is based on repeatable automated maneuvers with the entire kite system under realistic conditions. By measuring line forces and line angles, we determine the aerodynamic coefficients and lift-to-drag ratio as functions of the length ratio between power and steering lines. This nondimensional parameter characterizes the angle of attack of the wing and is varied automatically by the control unit on the towed test bench. During each towing run, several test cycles are executed such that mean values can be determined and errors can be minimized. We can conclude from this study that an objective measurement of specific dynamic properties of highly flexible membrane wings is feasible. The presented tow test method is suitable for quantitatively assessing and comparing different wing designs. The method represents an essential milestone for the development and characterization of tethered membrane wings as well as for the validation and improvement of simulation models. On the basis of this work, more complex maneuvers and a full degree of automation can be implemented in subsequent work. It can also be used for aerodynamic parameter identification.

A Development of a New Life Test Procedure for Fan Motors

2006 ◽  
Vol 321-323 ◽  
pp. 1539-1542
Author(s):  
Wae Gyeong Shin ◽  
Soo Hong Lee ◽  
Young Sik Song
Keyword(s):  
Automotive Industry ◽  
Field Condition ◽  
Test Procedure ◽  
Test Method ◽  
Accelerated Life Test ◽  
Test Time ◽  
Life Test ◽  
Dc Motors ◽  
Accelerated Life ◽  
Automotive Parts

Reliability of automotive parts has been one of the most interesting fields in the automotive industry. Especially small DC motor was issued because of the increasing adoption for passengers’ safety and convenience. For several years, small DC motors have been studied and some problems of a life test method were found out. The field condition was not considered enough in the old life test method. It also needed a lot of test time. For precise life estimation and accelerated life test, new life test procedure was developed based on measured field condition. First, vibration condition on vehicle and latent force on fan motor shaft were measured and correlated with each other. Second, test condition was decided by obtained data. Finally, life of fan motors was estimated by new life test method in shorter test time.

scholarly journals Development of an in vitro test procedure for the characterization of left atrial appendage occluder devices

2019 ◽  
Vol 5 (1) ◽  
pp. 461-463
Author(s):  
Finja Borowski ◽  
Sebastian Kaule ◽  
Stefan Siewert ◽  
Klaus-Peter Schmitz ◽  
Michael Stiehm ◽  
...  
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Standardized Test ◽  
Test Procedure ◽  
Test Method ◽  
Atrial Appendage ◽  
In Vitro Test ◽  
Watchman Device ◽  
Vitro Test

AbstractThe implantation of an occluder in the left atrial appendage (LAA) is an emerging therapy for the treatment of patients suffering from atrial fibrillation and with a contraindication to oral anticoagulation. The LAA occluder (LAAO) provides a reduction of the potential risk of strokes by thromboembolism. Currently, only a few CE-approved devices are available on the market and the number of clinical trials is comparatively low. Furthermore, there is currently no standardized test method available for testing functionality of the occluder, especially for testing safe anchorage and permeability. Therefore, the aim of this study is to establish an in vitro test method to prove anchorage mechanism and permeability regarding thromboembolism of the LAAO under physiological conditions. A standardized technical and fully parameterized silicone model of a LAA, based on studies of different morphologies and sizes, was developed. The LAA model was mounted onto the left atrial chamber of a commercial pulse duplicator system to simulate physiological hemodynamic conditions. The test was performed using the Watchman device (Boston Scientific, USA; size: 31 mm). The inner implantation diameter of the LAA model was designed according to a target compression of 10% for the Watchman device in the implanted configuration. Furthermore, thrombus-like particles (n=150, d=1,7±0,05 mm) were added to represent the flushing of thrombi out of the LAA after device implantation. Within several cycles it was confirmed that no particles were washed out of the LAA model with the implanted occluder leading to a full protection against thromboembolism. It could also be shown that the occluder is firmly anchored in the LAA. Pressure measurements with sensors in the left atrium and in the LAA distal to the occluder could also show that the occluder has no influence on the pressure conditions in the LAA.

scholarly journals Ductile Compressive Behavior of Biomedical Alloys

Metals ◽  
2019 ◽  
Vol 10 (1) ◽  
pp. 60
Author(s):  
Christian Affolter ◽  
Götz Thorwarth ◽  
Ariyan Arabi-Hashemi ◽  
Ulrich Müller ◽  
Bernhard Weisse
Keyword(s):  
Tensile Testing ◽  
316L Stainless Steel ◽  
Test Procedure ◽  
Test Method ◽  
Compressive Behavior ◽  
Flow Curves ◽  
Discussion Section ◽  
Ductile Metals ◽  
Compressive Testing ◽  
Micro Indentation

The mechanical properties of ductile metals are generally assessed by means of tensile testing. Compression testing of metal alloys is usually only applied for brittle materials, or if the available specimen size is limited (e.g., in micro indentation). In the present study a previously developed test procedure for compressive testing was applied to determine the elastic properties and the yield curves of different biomedical alloys, such as 316L (two different batches), Ti-6Al-7Nb, and Co-28Cr-6Mo. The results were compared and validated against data from tensile testing. The converted flow curves for true stress vs. logarithmic strain of the compressive samples coincided well up to the yield strength of the tensile samples. The developed compression test method was shown to be reliable and valid, and it can be applied in cases where only small material batches are available, e.g., from additive manufacturing. Nevertheless, a certain yield asymmetry was observed with one of the tested 316L stainless steel alloys and the Co-28Cr-6Mo. Possible hypotheses and explanations for this yield asymmetry are given in the discussion section.

scholarly journals Stability of Mycotoxins in Individual Stock and Multi-Analyte Standard Solutions

Toxins ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 94
Author(s):  
Mariya Kiseleva ◽  
Zakhar Chalyy ◽  
Irina Sedova ◽  
Ilya Aksenov
Keyword(s):  
Method Development ◽  
Wide Spectrum ◽  
Uv Spectroscopy ◽  
Solution Stability ◽  
Rp Hplc ◽  
Alternaria Toxins ◽  
Signal Suppression ◽  
Standard Solution ◽  
The Stability ◽  
Standard Solutions

Standard solutions of mycotoxins prepared in RP HPLC solvents from neat standards are usually used for analytical method development. Multi-mycotoxin HPLC-MS/MS methods necessitate stability estimation for the wide spectrum of fungal metabolites. The stability of individual diluted stock standard solutions of mycotoxins in RP-HPLC solvents and multi-analyte HPLC-MS/MS calibrants was evaluated under standard storage and analysis conditions. Individual stock standard solutions of aflatoxins, sterigmatocystin, A- and B-trichothecenes, zearalenone and its analogues, ochratoxin A, fumonisins, Alternaria toxins, enniatins and beauvericin, moniliformin, citrinin, mycophenolic, cyclopiazonic acids and citreoviridin were prepared in RP-HPLC solvents and stored at −18 °C for 14 months. UV-spectroscopy was utilized to monitor the stability of analytes, excluding fumonisins. The gradual degradation of α-, β-zearalenol and α-, β-zearalanol in acetonitrile was detected. Aflatoxins and sterigmatocystin, zearalenone, Alternaria toxins, enniatins and beauvericin, citrinin, mycophenolic, cyclopiazonic acids and citreoviridin can be referred to as stable. The concentration of the majority of trichothecenes should be monitored. Diluted multi-mycotoxin standard in water/methanol (50/50 v/v) solutions acidified with 0.1% formic acid proved to be stable in silanized glass at 23 °C exposed to light for at least 75 h (CV ≤ 10%). An unexpected manifestation of MS/MS signal suppression/enhancement was discovered in the course of multi-mycotoxin standard solution stability evaluation.

scholarly journals Quantitative determination of tolfenamic acid and its pharmaceutical formulation using FTIR and UV spectrometry

2013 ◽  
Vol 11 (9) ◽  
pp. 1533-1541 ◽  
Author(s):  
Sofia Ahmed ◽  
Muhammad Sheraz ◽  
Ceyla Yorucu ◽  
Ihtesham Rehman
Keyword(s):  
Uv Spectroscopy ◽  
Peak Height ◽  
Test Methods ◽  
Tolfenamic Acid ◽  
Test Procedures ◽  
Titration Method ◽  
Uv Spectrometry ◽  
Analytical Wavelength ◽  
Ft Ir ◽  
Tablet Dosage

AbstractAbstract The quantitative analysis of Tolfenamic Acid (TA) both as a pure compound and in tablet dosage form has been carried out using FT-IR and UV spectroscopy. In the FT-IR method, a number of characteristic absorption peaks were examined that could be used for analytical purpose. The analysis was carried out by preparing calibration curves of peak height/area versus TA content using two points baseline correction with fixed location, and the data was also analyzed through PLS regression model. In the UV method, ethanolic solutions of the drug were analyzed at 288 nm (λmax) using 480 as the value of A (1%, 1 cm) at the analytical wavelength. The results have been compared statistically for recovery, precision, accuracy and linearity with the British Pharmacopoeial titration method that showed good validity of both test procedures. The two test methods exhibited good recovery of TA with an accuracy of 99.75–100.83% and 99.53–100.11% by FTIR spectrometry for peak height and area respectively and 100.21% for UV method. However, UV spectrometry was found to be more accurate and precise on the basis of statistical evaluation and hence can be employed in the quality control of TA in pharmaceuticals as an alternative to the titration method. Graphical abstract

Study of Strength and Deformation Properties of the Composite Reinforcing Bar from the Continuous Basalt Fiber

2020 ◽  
Vol 1013 ◽  
pp. 132-138
Author(s):  
L.Yu. Stupishin ◽  
S.G. Emelyeanov ◽  
E.V. Savelyeva ◽  
M.L. Moshkevich
Keyword(s):  
Composite Structures ◽  
Test Procedure ◽  
Basalt Fiber ◽  
High Strength ◽  
Test Method ◽  
Strength Characteristics ◽  
Reinforcing Bar ◽  
Low Weight ◽  
Deformation Properties ◽  
Weight One

Composite structures require the use of modern reinforcing materials combining high strength characteristics and resistance to aggressive influences with low weight. One of the promising materials for the production of reinforcing products is basalt roving. The high strength of the thread in combination with fragility imposes certain limitations on its placement in the material, and requires new approaches to the design of the reinforcing bar itself. The article investigates the strength characteristics of a composite reinforcing bar made of a basalt complex thread proposed by the authors. The features of the test procedure and the mechanical characteristics of the reinforcing material are described. The effectiveness of the applied test method developed in the process of testing reinforcing rods is shown. An increase in the tensile strength of a composite reinforcing bar based on basalt fiber is established in comparison with products from fiber and roving.

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