Cleaning Validation: Quantitative Estimation of Atorvastatin in Production Area

2013 ◽  
Vol 67 (2) ◽  
pp. 164-171
Author(s):  
M. R. Moradiya ◽  
K. P. Solanki ◽  
P. A. Shah ◽  
K. G. Patel ◽  
V. T. Thakkar ◽  
...  
Keyword(s):  
Quantitative Estimation ◽  
Cleaning Validation ◽  
Production Area

scholarly journals Quantitative Determination and Sampling of Lamivudine and Zidovudine Residues for Cleaning Validation in a Production Area

2007 ◽  
Vol 90 (3) ◽  
pp. 715-719 ◽  
Author(s):  
Maria InÊs Rocha Miritello Santoro ◽  
Tatiana Tatit Fazio ◽  
Anil Kumar Singh ◽  
Erica Rosa Maria Kedor-Hackmann
Keyword(s):  
Chromatography Method ◽  
Drug Products ◽  
Cleaning Validation ◽  
Relative Standard ◽  
Immunodeficiency Virus ◽  
Production Area ◽  
The Mean ◽  
Liquid Chromatography Method ◽  
Carry Over

Abstract Lamivudine (3TC) and zidovudine (AZT) are systemic antiviral substances extensively used in human immunodeficiency virus (HIV) infected patients. Nowadays, 3TC, AZT, and several other pharmacologically potent pharmaceuticals are manufactured in the same production area. To assure quality of drug products and patient safety, properly validated cleaning methodology is necessary. A carefully designed cleaning validation and its evaluation can ensure that residues of 3TC and AZT will not carry over and cross contaminate the subsequent product. The aim of this study was to validate a simple analytical method for verification of residual 3TC and AZT in equipment used in the production area and to confirm the efficiency of the cleaning procedure. The liquid chromatography method was validated using a Nova-Pak<sup/> C18 column (3.9 150 mm, 4 m particle size) and methanolwater (20 + 80, v/v) as the mobile phase at a flow rate of 1.0 mL/min. Ultraviolet detection was made at 266 nm. The calibration curve was linear over a concentration range of 2.022.0 g/mL with a correlation coefficient of 0.9998. The detection and quantitation limits were 0.36 and 1.21 g/mL, respectively. The intra-day and interday precision expressed as relative standard deviation were below 2.0%. The mean recovery of the method was 99.19%. The mean extraction recovery from manufacturing equipment was 83.5%.

Quantitative determination and sampling of azathioprine residues for cleaning validation in production area

2007 ◽  
Vol 43 (4) ◽  
pp. 1495-1498 ◽  
Author(s):  
Tatiana Tatit Fazio ◽  
Anil Kumar Singh ◽  
Erika Rosa Maria Kedor-Hackmann ◽  
Maria Inês Rocha Miritello Santoro
Keyword(s):  
Quantitative Determination ◽  
Cleaning Validation ◽  
Production Area

scholarly journals DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF ARIPIPRAZOLE IN SWAB SAMPLES ON PHARMACEUTICAL MANUFACTURING EQUIPMENT SURFACES FOR CLEANING VALIDATION

2017 ◽  
Vol 9 (5) ◽  
pp. 141
Author(s):  
Sukhpreet Kaur ◽  
Indu Bala ◽  
Anjoo Kamboj
Keyword(s):  
Analytical Method ◽  
Sampling Method ◽  
Pharmaceutical Manufacturing ◽  
Manufacturing Equipment ◽  
Cleaning Procedure ◽  
Cleaning Validation ◽  
Production Area ◽  
Development And Validation ◽  
Validation Of Analytical Method

Objective: To validate simple analytical method and its application in the determination of residual aripiprazole in production area equipment and to confirm the efficiency of cleaning procedure.Methods: The swab sampling and UV method for residual estimation of aripiprazole in swab samples from equipment surfaces after manufacturing of three consecutive batches of aripiprazole 10 mg uncoated tablets were developed and validated.Results: The swab sampling method was developed and validated in order to obtain the suitable recovery (>90%). The swabs were saturated with acetonitrile. The UV method was developed using UV-Vis spectrophotometer at 255 nm. The calibration curve was linear (r2 =1.0000) over a concentration range of 1-30 µg/ml. The LOD and LOQ were 0.43 µg/ml and 1.32µg/ml, respectively. No interference from swab solution was observed and samples were stable for 24h. The determined concentration varying from 1.00-5.687µg/swab was well below the calculated limit of contamination i.e., 24.2µg/swab or 24.2 µg/25 cm2.Conclusion: The results obtained from cleaning procedure confirmed that the proposed procedure was able to remove aripiprazole from equipment surfaces below the value of 10 ppm criteria. So the proposed validated UV method with appropriate swab wipe procedure could be applicable for cleaning validation on residues of aripiprazole.

scholarly journals Simultaneous Quantitative Estimation of Lisinopril and Hydrochlorothiazide Residues Using HPLC for Cleaning Validation

2020 ◽  
Vol 15 (1) ◽  
pp. 8-21
Author(s):  
Imeda Rubashvili ◽  
Natela Karukhnishvili ◽  
Khatuna Makharadze
Keyword(s):  
Quantitative Estimation ◽  
Cleaning Validation

Plasma Fibrin Stabilising Factor (F. S. F.) Activity in Normal Subjects and Patients with Chronic Liver Disease

1969 ◽  
Vol 21 (01) ◽  
pp. 134-143 ◽  
Author(s):  
W. D Walls ◽  
M. S Losowsky
Keyword(s):  
Liver Disease ◽  
Chronic Liver Disease ◽  
Clinical Improvement ◽  
Quantitative Estimation ◽  
Kinetic Method ◽  
Normal Subjects ◽  
Chronic Liver ◽  
Clinical Severity ◽  
Plasma Fibrinogen ◽  
Normal Range

SummaryA kinetic method for the quantitative estimation of plasma F.S.F. activity is described and discussed.This method was applied to normal subjects and to patients with chronic liver disease. The plasma F.S.F. activity was uninfluenced by either sex or age, and the normal range has been defined.A significant decrease in plasma F.S.F. activity was observed in patients with chronic liver disease. Subnormal levels of activity were found in 25% of such patients but were unrelated to episodes of abnormal haemorrhage. Plasma F.S.F. activity tended to be lower in patients with disease of greater clinical severity. In 2 patients showing clinical improvement there was an increase in plasma F. S. F. activity.It was confirmed that plasma fibrinogen levels increase with age.

Social development of modern Russia: trends, risks, prospects

2018 ◽  
pp. 76-89
Author(s):  
E. M. Avraamova ◽  
V. N. Titov
Keyword(s):  
Middle Class ◽  
Social Development ◽  
Social Structure ◽  
Structure Formation ◽  
Resource Availability ◽  
Social Dynamics ◽  
Quantitative Estimation ◽  
Resource Potential ◽  
Institutional Conditions ◽  
Resource Characteristics

The analysis of present-time directions in the study of social development has allowed to identify the resource approach as the most productive one which enables to assess social dynamics through the range of resource characteristics of different population groups and abilities of the relevant groups to apply development resources in the current economic and institutional conditions. Basing on the sociological survey conducted by ISAP RANEPA, the quantitative estimation of material and social recourses of the population has been made; integral values of the resource potential have been calculated as well. The issues of social structure formation are analyzed through the aspect of resource availability; the barriers of Russian middle-class enlargement are defined.

QUANTITATIVE ESTIMATION OF URINARY PREGNANETRIOL, PREGNANETRIOLONE, TETRAHYDRO S AND Δ5-PREGNENETRIOL IN THE INVESTIGATION OF ADRENOCORTICAL FUNCTION

1969 ◽  
Vol 60 (4) ◽  
pp. 657-668 ◽  
Author(s):  
Frances J. Thomas ◽  
A. W. Steinbeck
Keyword(s):  
Congenital Adrenal Hyperplasia ◽  
Cushing’S Syndrome ◽  
Adrenocortical Carcinoma ◽  
Quantitative Estimation ◽  
Cushing's Syndrome ◽  
Adrenocortical Function ◽  
Adrenal Hyperplasia ◽  
Ectopic Acth ◽  
Modified Method ◽  
Idiopathic Hirsutism

ABSTRACT A modified method for the estimation of urinary pregnanetriol, pregnanetriol, pregnanetriolone, Δ5-pregnenetriol and tetrahydro S was investigated. The steroids, separated by chromatography, were measured quantitatively, tetrahydro S by reaction with blue tetrazolium and the other three as acetaldehydogenic substances. The excretion of these steroids was studied in suspected instances of adrenal and/or ovarian disease. Urinary pregnanetriol and tetrahydro S levels were normal in Cushing's syndrome, secondary adrenocortical carcinoma, the Stein-Leventhal syndrome, idiopathic hirsutism and hypertension. Tetrahydro S was doubtfully elevated in an instance of ectopic ACTH Cushing's syndrome. Pregnanetriol excretion was elevated in untreated cases of congenital adrenal hyperplasia and after treatment in some. Pregnanetriolone was found in all patients with congenital adrenal hyperplasia, including those receiving cortisone. Pregnanetriolone was also detected in Cushing's syndrome, secondary adrenocortical carcinoma, the Stein-Leventhal syndrome, ectopic ACTH Cushing's syndrome and suspected congenital adrenal hyperplasia. Δ5-pregnenetriol was present as a glucuronide in the Stein-Leventhal syndrome and idiopathic hirsutism. The diagnostic implications of these results are discussed.

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