Development of Guidelines for Accurate Measurement of Small Volume Parenteral Products Using Syringes

2019 ◽  
pp. 001857871987386
Author(s):  
Melanie A. Jordan ◽  
Dimpa Choksi ◽  
Kelsey Lombard ◽  
Lynn R. Patton
Keyword(s):  
Standard Deviation ◽  
Small Volume ◽  
Selection Methods ◽  
Accuracy And Precision ◽  
Relative Standard ◽  
Volume Measurements ◽  
The Mean ◽  
Precision And Accuracy ◽  
Parenteral Products ◽  
Sterile Product

Background: Syringes are commonly used in pharmacy compounding for the measurement of small volumes, especially in the preparation of sterile products for injection and infusion. However, there are no current official guidelines for the proper use of syringes in measuring small volumes. Objective: The purpose of this project was to determine the accuracy and precision of commercially available syringes in measuring small volumes during sterile product preparation to make recommendations for syringe size selection. Methods: To assess precision and accuracy of syringes, 3 separate investigators measured 5%, 10%, or 20% (n = 30 each) of the volume of a 1-, 3-, 5-, 10-, or 20-mL syringe with an attached 18G, 1½” needle by drawing sterile water for injection from a vial. Delivered volumes were measured gravimetrically using an electronic balance and converted to volume using the specific gravity of water (1.0). Accuracy is represented as the mean and standard deviation, while precision is represented as percent relative standard deviation. Differences were assessed using a 1-way analysis of variance with Bonferroni adjustments and significance set at P < .05. Results: Precision and accuracy were highly variable and often significantly ( P < .05) different compared to the theoretical volume delivered both within and between investigators. An increased likelihood of unacceptable error (>5%) was observed when less than 20% of the labeled capacity of a syringe was measured. Mean percent error ranged from 1.4% to 18.6%, despite manufacturer specification of ±5% accuracy, suggesting proper technique as a major factor in small-volume measurements. Conclusion: In addition to proper, validated training of syringe users, we recommend that users measure no less than 20% of the indicated volume of the syringe while choosing syringes as close as possible to the desired measurement. When possible, very small volumes should be diluted to meet the minimum volume of the smallest syringe available. Implementation of these recommendations will improve accurate dosing and, ultimately, patient safety.

Considerations in the preparation of laboratory samples for the analysis of ochratoxin A in wheat

2012 ◽  
Vol 5 (2) ◽  
pp. 107-116 ◽  
Author(s):  
S.A. Tittlemier ◽  
M. Roscoe ◽  
C. Kobialka ◽  
R. Blagden
Keyword(s):  
Ochratoxin A ◽  
Whole Grain ◽  
Laboratory Sample ◽  
Test Portion ◽  
Homogeneous Sample ◽  
Ambient Temperatures ◽  
Accuracy And Precision ◽  
Relative Standard ◽  
The Mean ◽  
Ground Wheat

A process used to prepare the test portion of ground wheat from the whole grain laboratory sample for ochratoxin A (OTA) analysis using dry comminution with homogenisation and sub-sampling via a rotary sample divider was developed and evaluated. With respect to OTA content, the developed process produced a homogeneous sample of ground wheat from 10 kg of whole grain. Relative standard deviations of the mean OTA concentration for five naturally contaminated wheat samples processed using the developed method ranged from 9% to 19% over a relevant concentration range of 1.7 to 7.6 mg/kg. Additional studies demonstrated that OTA was stable in ground wheat with moisture content between 12 to 13% for at least a year when stored at ambient temperatures. Further examination of the developed comminution and dividing procedure demonstrated that higher concentrations were measured in smaller sized particles, indicating that the accuracy and precision of OTA analyses could be affected by the particle size of ground wheat.

Determination of Maleic Hydrazide Residues in Tobacco and Vegetables

1973 ◽  
Vol 56 (5) ◽  
pp. 1164-1172
Author(s):  
Milan Ihnat ◽  
Robert J Westerby ◽  
Israel Hoffman
Keyword(s):  
Standard Deviation ◽  
Present Method ◽  
Maleic Hydrazide ◽  
Collaborative Study ◽  
Official Method ◽  
Sample Weight ◽  
Relative Standard ◽  
The Mean ◽  
Pipe Tobacco

Abstract The distillation-spectrophotometric method of Hoffman for determining maleic hydrazide has been modified to include a double distillation and was applied to the determination of 1–30 ppm maleic hydrazide residues in tobacco and vegetables. Recoveries of 1–23 μg added maleic hydrazide were independent of weight of maleic hydrazide, but did depend on sample and sample weight. The following recoveries were obtained from 0.5 g sample: pipe tobacco, 84%; commercially dehydrated potato, 83%; cigar tobacco, 81%; dried potato, 76%; fluecured tobacco, 73%; dried carrot, 71%. In the absence of sample, the recovery was 82%. When appropriate standard curves were used, maleic hydrazide levels determined in tobacco samples were essentially independent of sample weight in the range 0.1–3 g. The mean relative standard deviation for a variety of field-treated and fortified tobacco samples containing 1–28 ppm maleic hydrazide was 3%. The precision and sensitivity of this procedure seem to be substantial improvements over official method 29.111–29.117. It is recommended that the present method be subjected to a collaborative study.

scholarly journals Internal consistency of the Regional Brewer Calibration Centre for Europe triad during the period 2005–2016

2018 ◽  
Vol 11 (7) ◽  
pp. 4059-4072 ◽  
Author(s):  
Sergio Fabián León-Luis ◽  
Alberto Redondas ◽  
Virgilio Carreño ◽  
Javier López-Solano ◽  
Alberto Berjón ◽  
...  
Keyword(s):  
Standard Deviation ◽  
Relative Standard Deviation ◽  
Data Sets ◽  
Individual Values ◽  
Relative Standard ◽  
The World ◽  
The Mean ◽  
The Individual ◽  
Ozone Column

Abstract. Total ozone column measurements can be made using Brewer spectrophotometers, which are calibrated periodically in intercomparison campaigns with respect to a reference instrument. In 2003, the Regional Brewer Calibration Centre for Europe (RBCC-E) was established at the Izaña Atmospheric Research Center (Canary Islands, Spain), and since 2011 the RBCC-E has transferred its calibration based on the Langley method using travelling standard(s) that are wholly and independently calibrated at Izaña. This work is focused on reporting the consistency of the measurements of the RBCC-E triad (Brewer instruments #157, #183 and #185) made at the Izaña Atmospheric Observatory during the period 2005–2016. In order to study the long-term precision of the RBCC-E triad, it must be taken into account that each Brewer takes a large number of measurements every day and, hence, it becomes necessary to calculate a representative value of all of them. This value was calculated from two different methods previously used to study the long-term behaviour of the world reference triad (Toronto triad) and Arosa triad. Applying their procedures to the data from the RBCC-E triad allows the comparison of the three instruments. In daily averages, applying the procedure used for the world reference triad, the RBCC-E triad presents a relative standard deviation equal to σ = 0.41 %, which is calculated as the mean of the individual values for each Brewer (σ157 = 0.362 %, σ183 = 0.453 % and σ185 = 0.428 %). Alternatively, using the procedure used to analyse the Arosa triad, the RBCC-E presents a relative standard deviation of about σ = 0.5 %. In monthly averages, the method used for the data from the world reference triad gives a relative standard deviation mean equal to σ = 0.3 % (σ157 = 0.33 %, σ183 = 0.34 % and σ185 = 0.23 %). However, the procedure of the Arosa triad gives monthly values of σ = 0.5 %. In this work, two ozone data sets are analysed: the first includes all the ozone measurements available, while the second only includes the simultaneous measurements of all three instruments. Furthermore, this paper also describes the Langley method used to determine the extraterrestrial constant (ETC) for the RBCC-E triad, the necessary first step toward accurate ozone calculation. Finally, the short-term or intraday consistency is also studied to identify the effect of the solar zenith angle on the precision of the RBCC-E triad.

An Adaptive Statistically Based Controller for Through-Feed Centerless Grinding

2000 ◽  
Vol 123 (3) ◽  
pp. 380-386 ◽  
Author(s):  
Richard W. Cowan ◽  
Daniel J. Schertz ◽  
Thomas R. Kurfess
Keyword(s):  
Standard Deviation ◽  
Statistical Approach ◽  
High Volume ◽  
Manufacturing Processes ◽  
Control Methods ◽  
Statistical Control ◽  
Accuracy And Precision ◽  
Self Tuning ◽  
Centerless Grinding ◽  
The Mean

The purpose of this research is to develop a statistically based controller that is “self-tuning.” High volume manufacturing processes such as through-feed centerless grinding are best controlled with a statistical approach, but traditional methods of statistical control generally rely on fixed parameters that must be determined. These values must be precisely known and the true physical characteristics they model must remain constant throughout grinding, or traditional statistical control methods may break down. The mean and standard deviation of a process are measures of its accuracy and precision. The scheme developed here makes control decisions based on the real-time values of these quantities. This self-adjusting ability can compensate for changes in machine parameters as they occur.

Fluorometric Determination of Selenium in Foods

1974 ◽  
Vol 57 (2) ◽  
pp. 368-372 ◽  
Author(s):  
Milan Ihnat
Keyword(s):  
Standard Deviation ◽  
Milk Powder ◽  
Skim Milk ◽  
Skim Milk Powder ◽  
Food Samples ◽  
Fluorometric Method ◽  
Fluorometric Determination ◽  
Relative Standard ◽  
The Mean

Abstract A fluorometric method using 2,3-diaminonaphthalene for estimating selenium has been evaluated with regard to its applicability to food samples. Charring of the sample during digestion appeared to result in losses of native and added selenium from some samples, so a modified wet digestion procedure was introduced. Digestion first in nitric acid followed by a mixture of nitric-perchloric-sulfuric acids substantially reduced the incidence of sample charring for a variety of foods. The mean apparent recovery of selenium added as selenite or selenate at 100 and 500 ng levels to 0.1 and 1.0 g corn cereal, skim milk powder, and meat and 0.1 g fish was 101.0%; the actual recovery of the same levels of selenium from standard solutions was 96.6%. For a variety of samples containing 5—750 ng native or added selenium, the standard deviation as 4.7 + 1.95 X 10-2W ng, where W = ng selenium in the sample taken for analysis. The relative standard deviation (RSD) as a function of selenium weight (ng) was 50% (10), 6.7% (100), 4.3% (200), 3.1% (400), 2.7% (600), and 2.5% (800). The detection limit (weight of selenium at which RSD = 50%) was 10 ng at a mean blank level of 25 ng.

Radioisotope Dilution Technique for Determination of Vitamin B12 in Foods

1982 ◽  
Vol 65 (1) ◽  
pp. 85-88 ◽  
Author(s):  
Patrick J Casey ◽  
Keevin R Speckman ◽  
Frank J Ebert ◽  
William E Hobbs
Keyword(s):  
Standard Deviation ◽  
Vitamin B12 ◽  
Relative Standard Deviation ◽  
Extraction Procedure ◽  
Dilution Technique ◽  
Microbiological Method ◽  
Relative Standard ◽  
Wide Range ◽  
The Mean

Abstract A radioisotope dilution (RID) method for the determination of vitamin B12 is presented. The method combines a standard extraction procedure (AOAC 43.108,12th ed.) with a commercially available RID assay kit. The method was evaluated on a wide range of fortified and unfortified food products. Recovery studies on both groups yielded average recoveries of 98.1 and 95.8%, respectively. Reproducibility data generated from replicate analyses on both groups gave a relative standard deviation of 6.9% for the fortified group and 9.2% for the unfortified group. For the samples studied, the mean vitamin B12 content determined by the RID method was 8.01 μg/100 g vs imean of 7.54 μg/100 g by the AOAC microbiological method; the correlation coefficient was r = 0.983.

Combined Determination of Phosphorus and Arsenic in Molybdenum Concentrate by Molybdenum Blue Spectrophotometric Method

2014 ◽  
Vol 1033-1034 ◽  
pp. 521-525
Author(s):  
Cheng Ying Zhou ◽  
Wei Qu ◽  
Liu Lu Cai
Keyword(s):  
Standard Deviation ◽  
Good Accuracy ◽  
Standard Addition ◽  
Additive Property ◽  
Molybdenum Blue ◽  
Accuracy And Precision ◽  
Relative Standard ◽  
Molybdenum Concentrate ◽  
Total Absorbance

This paper determined the total absorbance of phosphorus molybdenum blue and arsenic molybdenum blue by using the additive property of their absorbance values. By eliminating the interference of arsenic by reduction masking with composite reducing agent Na2SO3-Na2S2O3-KBr, the absorbance of phosphorus could be obtained. Thus, the content of phosphorus and arsenic could be calculated, respectively. The results show that the work curves of this method for phosphorus and arsenic are consistent with Beer’s law when the content of phosphorus and arsenic is 0-0.60ug/mL and 0-2.00ug/mL, respectively. The standard addition recovery rate of phosphorus and arsenic is 98.80%-101.04% and 99.00%-101.50%, respectively. The relative standard deviation of phosphorus and arsenic is less than 4.0% with good accuracy and precision. This method is simple and fast to determine phosphorus and arsenic in molybdenum concentrate, and the results are accurate and reliable.

Comparison of Automatic and Manual Turbidimetric Analyses of Tylosin in Feeds with the Plate Method

1973 ◽  
Vol 56 (2) ◽  
pp. 363-366
Author(s):  
Hussein S Ragheb ◽  
H Latham Breunig ◽  
Robert E Scroggs
Keyword(s):  
Standard Deviation ◽  
Relative Standard Deviation ◽  
Plate Method ◽  
Relative Standard ◽  
Significant Difference ◽  
Aoac Method ◽  
Turbidimetric Assay ◽  
The Mean ◽  
The Difference ◽  
Feed Samples

Abstract Two laboratories participated in a comparison of a manual turbidimetric assay with the AUTOTURB® System and the AOAC method of analysis of tylosin in 4 feed samples. Results showed no significant difference between the 2 turbidimetric assays. When the AOAC method was considered, the difference between laboratories was significant. On an overall basis the turbidimetric methods were significantly higher than the plate method. The relative standard deviation was higher (6.72%) for the plate assay versus turbidimetric assay (4.5%). The mean recovery in both laboratories was significantly less than the labeled amount of tylosin by all 3 methods.

Combination of Total Solids Determined by Oven Drying and Fat Determined by Mojonnier Extraction for Measurement of Solids-Not-Fat Content of Raw Milk: Collaborative Study

1989 ◽  
Vol 72 (5) ◽  
pp. 719-724 ◽  
Author(s):  
Jenny L Clark ◽  
David M Barbano ◽  
Chapman E Dunham
Keyword(s):  
Standard Deviation ◽  
Collaborative Study ◽  
Raw Milk ◽  
Fat Content ◽  
Oven Drying ◽  
Total Solids ◽  
Ether Extraction ◽  
Relative Standard ◽  
The Mean ◽  
Forced Air

Abstract Each of 9 laboratories analyzed 9 pairs of blind duplicate raw milk samples for fat, using the Mojonnier ether extraction method (16.E13-16.E17), and for total solids, using a new direct forced air oven method. Solids-not-fat was determined by subtracting percent fat from percent total solids. The solids-not-fat content of the samples tested in the collaborative study ranged from 8.48 to 9.36%. The average repeatability standard deviation (sr) and the average reproducibility standard deviation (sR) for the solids-not-fat method were 0.019 and 0.041, respectively. Average repeatability (RSDr) and reproducibility (RSDR) relative standard deviations were 0.218 and 0.466%, respectively. The mean repeatability value (r) was 0.055; the mean reproducibility value (R) was 0.117. The difference between milk total solids determined by direct forced air oven drying and milk fat determined by Mojonnier ether extraction has been approved for interim official first action for determination of solids-not-fat content of milk.

scholarly journals Performance Qualification of Two Processor-controlled Dosing Pumps for the Production of Mixed Infusion Solutions in a Closed System

2016 ◽  
Vol 1 (1) ◽  
Author(s):  
Terry Hennache ◽  
Gwénaëlle Clabaut ◽  
Lina Mustapha ◽  
Jean-Marc Dubaele ◽  
Frédéric Marçon
Keyword(s):  
Standard Deviation ◽  
Relative Standard Deviation ◽  
Closed System ◽  
Potassium Concentration ◽  
Sodium Concentration ◽  
Relative Bias ◽  
Relative Standard ◽  
Performance Qualification ◽  
The Mean

Abstract: The aim of this study is to carry out performance qualifications of 2 processor-controlled dosing pumps for the production of mixed infusion solutions in a closed system.: Two dosing pumps have been qualified regarding their use: a processor-controlled dosing pump MediMix: The mean relative biases found with different products used for the qualifications of the two controllers were below the manufacturer’s specifications. When pumping operations were performed outside the manufacturer’s recommended ranges of volumes, relative bias remained below 10 %. Low relative bias (<3 %) and relative standard deviation (<1 %) were also found with routine controls (weight, osmolality, sodium concentration, potassium concentration) performed on test batches produced with the 12-pumps automated compounding device (ACD).: The single pump controller MediMix

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