scholarly journals PRE-EQC: A Proficiency Testing Program for Pre-Analytical and Analytical Monitoring Using Pooled Samples without Preservatives

2020 ◽  
pp. 145-152
Author(s):  
Shyamali Pal
Keyword(s):  
Quality Assurance ◽  
Biological Fluid ◽  
Storage Condition ◽  
Medical Laboratory ◽  
Analytical Monitoring ◽  
Icteric Index ◽  
Plastic Bag ◽  
Iso 13528 ◽  
Transport Condition ◽  
The Stability

Aim: External Quality Assurance (EQA) is basic requirement of a medical laboratory to assess the quality assurance and achieve the accreditation. The available EQA schemes evaluate the analytical performances of the laboratory but neither evaluate pre analytical factors nor mimic actual laboratory process. PRE-EQC has combined both performances in single scheme and assisting the participant laboratories to take appropriate corrective action and interpretations. Design: Pre-Analytical monitoring evaluates transport condition, correlation of the stability of samples and temperature, storage condition and environment of the laboratory of the participants and its effect on the results. A sample is specially prepared to estimate haemolysis, lipemic and icteric index. Clinical Biochemistry: Serum, fluoride and biological fluid (CSF exempted) samples are pooled from the routine collection of specimens. Pooled fractions are homogenized in a rotary shaker for 10 minutes. The clear samples are poured in individual double pack primary containers, which are placed between two gel packs in a “biohazard” labelled plastic bag. Temperature is recorded, kept in insulated thermocol box and sent to the destination. Urine Routine & Microalbumin, Creatinine Examination: Urine sample is stabilized using preservative. Methods: The process of sample pool to result submission has been completed within 6 days as samples are without preservative. Stability mimicking the transport, homogeneity and validation of assigned values were done. Statistical Calculations: As per ISO 13528:2015. Results and Discussion: The SD of the assigned values showed better performance than existing schemes and within the range of CLIA recommended SD. Conclusion: The PRE-EQC sample from direct and microalbumin from direct specimen has achieved good reproducibility than lyophilized material.

Stability of dronabinol capsules when stored frozen, refrigerated, or at room temperature

2016 ◽  
Vol 73 (14) ◽  
pp. 1088-1092 ◽  
Author(s):  
Michael F. Wempe ◽  
Alan Oldland ◽  
Nancy Stolpman ◽  
Tyree H. Kiser
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Oxidative Degradation ◽  
Storage Condition ◽  
Sesame Oil ◽  
Forced Degradation ◽  
Product Packaging ◽  
Time Points ◽  
The Stability ◽  
Minimal Reduction

Abstract Purpose Results of a study to determine the 90-day stability of dronabinol capsules stored under various temperature conditions are reported. Methods High-performance liquid chromatography (HPLC) with ultraviolet (UV) detection was used to assess the stability of dronabinol capsules (synthetic delta-9-tetrahydrocannabinol [Δ9-THC] mixed with high-grade sesame oil and other inactive ingredients and encapsulated as soft gelatin capsules) that were frozen, refrigerated, or kept at room temperature for three months. The dronabinol capsules remained in the original foil-sealed blister packs until preparation for HPLC–UV assessment. The primary endpoint was the percentage of the initial Δ9-THC concentration remaining at multiple designated time points. The secondary aim was to perform forced-degradation studies under acidic conditions to demonstrate that the HPLC–UV method used was stability indicating. Results The appearance of the dronabinol capsules remained unaltered during frozen, cold, or room-temperature storage. Regardless of storage condition, the percentage of the initial Δ9-THC content remaining was greater than 97% for all evaluated samples at all time points over the three-month study. These experimental data indicate that the product packaging and the sesame oil used to formulate dronabinol capsules efficiently protect Δ9-THC from oxidative degradation to cannabinol; this suggests that pharmacies can store dronabinol capsules in nonrefrigerated automated dispensing systems, with a capsule expiration date of 90 days after removal from the refrigerator. Conclusion Dronabinol capsules may be stored at room temperature in their original packaging for up to three months without compromising capsule appearance and with minimal reduction in Δ9-THC concentration.

scholarly journals The Influence of UV Radiation on the Degradation of Pharmaceutical Formulations Containing Quercetin

Molecules ◽  
2020 ◽  
Vol 25 (22) ◽  
pp. 5454
Author(s):  
Iwona Golonka ◽  
Stanisław Wilk ◽  
Witold Musiał
Keyword(s):  
Quality Assurance ◽  
Fourier Transform ◽  
Infrared Spectroscopy ◽  
Decay Rate ◽  
Ftir Spectroscopy ◽  
Polyacrylic Acid ◽  
Decomposition Rate ◽  
Pharmaceutical Formulations ◽  
Polymeric Gels ◽  
The Stability

The aim of this study was to assess the photostability of quercetin in the presence of anionic and nonionic polymeric gels with varied compositions of an added component—glycerol. The samples were irradiated continuously at constant temperature. The stability of quercetin in solution and incorporated into the gels was evaluated by an UV-Vis spectrophotometer. FTIR spectroscopy (Fourier-transform infrared spectroscopy) was used to detect the changes in the structure of quercetin depending on the polymer used in the gel, and on the exposure time. Photostabilization is an important aspect of quality assurance in photosensitive compounds. The decomposition rate of quercetin in the ionic preparation of polyacrylic acid (PAA) with glycerol was 1.952·10−3 min−1, whereas the absence of glycerol resulted in a decay rate of 5.032·10−4 min−1. The formulation containing non-ionic methylcellulose resulted in a decomposition rate of quercetin in the range of 1.679·10−3 min−1. The decay rate of quercetin under light influence depended on the composition of the gel. It was found that the cross-linked PAA stabilized quercetin and the addition of glycerol accelerated the photodegradation.

scholarly journals Stability of Extemporaneously Prepared Lansoprazole Suspension at Two Temperatures

2013 ◽  
Vol 18 (2) ◽  
pp. 122-127 ◽  
Author(s):  
Jordan T. Morrison ◽  
Ralph A. Lugo ◽  
Jim C. Thigpen ◽  
Stacy D. Brown
Keyword(s):  
Sodium Bicarbonate ◽  
Room Temperature ◽  
Internal Standard ◽  
Storage Condition ◽  
Significant Difference ◽  
Expiration Time ◽  
Liquid Chromatography Tandem Mass ◽  
Two Temperatures ◽  
The Stability ◽  
Oral Sodium

OBJECTIVE The purpose of this study was to examine the stability of a generic lansoprazole product in a 3 mg/mL sodium bicarbonate suspension under room temperature and refrigerated conditions. METHODS Lansoprazole suspensions (3 mg/mL) were prepared in triplicate using an 8.4% sodium bicarbonate vehicle for each storage condition (room temperature and refrigerated). During 1 month, samples from each replicate were periodically removed and analyzed for lansoprazole concentration by liquid chromatography–tandem mass spectrometry (LC-MS/MS). Each sample was spiked with 10 mg/L omeprazole to serve as the internal standard. A positive electrospray LC-MS/MS method was validated over the calibration range of 5 to 25 mg/L using Food and Drug Administration Guidance. The identities of the analyte and internal standard in the samples were verified by monitoring the MS/MS transitions of m/z 370 to m/z 252 and m/z 346 to m/z 198 for lansoprazole and omeprazole, respectively. Additionally, the pH of the suspensions was monitored throughout the study. RESULTS The stability of lansoprazole in the oral sodium bicarbonate suspension under refrigeration is compromised prior to what has been previously reported in the literature. Samples kept at room temperature lost >10% of the lansoprazole after 48 hours compared with the refrigerated samples, which maintained integrity up to 7 days. No statistically significant difference was found between the pH of the room temperature and refrigerated suspension samples, indicating that this factor is not the cause for the differences in stability at these two conditions. CONCLUSIONS This study suggests that the extemporaneously compounded lansoprazole oral suspension prepared in 8.4% sodium bicarbonate should not be stored in plastic oral syringes longer than 48 hours at room temperature and no longer than 7 days when refrigerated. These data indicate an expiration time earlier than that previously reported for the refrigerated product (14 days).

scholarly journals Quantification of an External Motion Surrogate for Quality Assurance in Lung Cancer Radiation Therapy

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Jens Wölfelschneider ◽  
Tobias Brandt ◽  
Sebastian Lettmaier ◽  
Rainer Fietkau ◽  
Christoph Bert
Keyword(s):  
Quality Assurance ◽  
Radiation Therapy ◽  
Global Minimum ◽  
Tumor Volume ◽  
Lung Tumor ◽  
Free Breathing ◽  
Breath Hold ◽  
Target Volumes ◽  
Posterior Direction ◽  
The Stability

The purpose of this work was to validate the stability of the end exhale position in deep expiration breath hold (DEBH) technique for quality assurance in stereotactic lung tumor radiation therapy. Furthermore, a motion analysis was performed for 20 patients to evaluate breathing periods and baseline drifts based on an external surrogate. This trajectory was detected using stereo infrared (IR) cameras and reflective body markers. The respiratory waveform showed large interpatient differences in the end exhale position during irradiation up to 18.8 mm compared to the global minimum. This position depends significantly on the tumor volume. Also the baseline drifts, which occur mostly in posterior direction, are affected by the tumor size. Breathing periods, which depend mostly on the patient age, were in a range between 2.4 s and 7.0 s. Fifteen out of 20 patients, who showed a reproducible end exhale position with a deviation of less than 5 mm, might benefit from DEBH due to smaller planning target volumes (PTV) compared to free breathing irradiation and hence sparing of healthy tissue. Patients with larger uncertainties should be treated with more complex motion compensation techniques.

scholarly journals Quality assurance on the example of the welding process for gear lever

2018 ◽  
Vol 19 (9) ◽  
pp. 219-224
Author(s):  
Stanisław Pałubicki
Keyword(s):  
Quality Assurance ◽  
Continuous Improvement ◽  
Automotive Industry ◽  
Welding Process ◽  
Product Selection ◽  
Production Processes ◽  
The Stability ◽  
Gear Lever ◽  
Manufacturing Stage

Quality is one of the basics of product selection by customers. Therefore, the main area of quality management is the identification of customers, their requirements and expectations. This is especially important in the automotive industry. Today's enterprises, wanting to strengthen their market position by improving the quality of their products, constantly control their products. Systems responsible for monitoring production allow to ensure the course of production processes in supervised conditions. The monitoring and recording of events that occur during production is of key importance. This is the basis for analyzing the stability of the production process, which is a key aspect of continuous improvement of quality. Thanks to this approach, it is possible to prevent the generation of costs related to the removal of defective products created at the manufacturing stage, as well as to reduce the number of complaints.

scholarly journals Stability of purified Vero cell-derived inactivated Japanese Encephalitis vaccines under various conditions

2015 ◽  
Vol 4 (3) ◽  
pp. 69
Author(s):  
Sanxia Zhao ◽  
Shijie Yan ◽  
Jianqiu Bai ◽  
Chunbo Wang
Keyword(s):  
Vero Cell ◽  
Japanese Encephalitis ◽  
Storage Condition ◽  
Test Standards ◽  
Aluminum Level ◽  
Residual Aluminum ◽  
Duration Of Storage ◽  
Apparent Decrease ◽  
The Stability ◽  
T Values

<p>The stability of three batches of purified Vero cell-derived, inactivated Japanese encephalitis vaccines was evaluated under various conditions. Vaccine products were stored separately at 2 to 8 ℃ and 37 ℃. At various times, vaccines samples were taken and evaluated for appearance, pH, residual aluminum, titer, and the results were compared with corresponding data of release tests. All three batches of vaccine products were conforming to release test standards, with residual host DNA being less than 100pg/dose, residual protein being 23.5ng/ml, and residual bovine albumin being 8.9ng/dose, respectively. During storage under various conditions, no abnormal appearance was observed; pH was slightly increased and residual aluminum level was decreased, both of which were within acceptable range of standards. The titers of vaccine products were determined by Plaque Reduction Neutralization Test (PRNT). Three batches of vaccine products that were stored at 37±1℃ for 4 weeks were found to maintain titers of above 95%. When stored for 12 weeks, there was an apparent decrease of titer (maintained at 78.6% to 81.5%). Except batch 20081101 showed T values less than standard, other two batches were still qualified. Three batches of vaccine products that were stored at 2~8℃ for 36 months were found to maintain titer of 85.4% ~86.7%, with potency T values above that of reference product. At major time points of this storage condition, sterility, abnormal toxicity, and endotoxin level were all conforming to standards. This study indicates that these vaccine products have excellent stability within specific duration of storage under various conditions.</p>

scholarly journals Stability-indicating LC-MS Method for Determination of Stability of Extemporaneously Compounded Buprenorphine Oral Syringes for Neonatal Abstinence Syndrome

2021 ◽  
Vol 26 (4) ◽  
pp. 395-404
Author(s):  
Ankit Rochani ◽  
Vinh Nguyen ◽  
Robin Becker ◽  
Walter Kraft ◽  
Gagan Kaushal
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Storage Condition ◽  
Stability Study ◽  
Neonatal Abstinence Syndrome ◽  
Limited Information ◽  
Abstinence Syndrome ◽  
Stability Indicating ◽  
The Stability

OBJECTIVE In the hospital settings, buprenorphine is used for the treatment of patients with neonatal abstinence syndrome. It is extemporaneously compounded and stored in oral plastic syringes. However, limited information exists about the stability of buprenorphine and its compounded formulations when stored under specific conditions. Hence, we developed a stability-indicating high-performance liquid chromatography–mass spectrometry (LC-MS) method to analyze the stability of buprenorphine over time. METHODS A stability-indicating LC-MS method was developed to map the potential degradation peaks of buprenorphine when exposed to acidic, basic, and oxidative conditions. This method was used to study the stability of compounded buprenorphine oral syringes stored under refrigeration (2°C–8°C) and room temperature (25°C ± 2°C with 60% relative humidity). Syringes from each storage condition were assessed for stability using pH meter and stability-indicating LC-MS assay for 30 days. RESULTS Buprenorphine gets completely degraded in the presence of acid at the end of 1 hour of exposure. Various degradation peaks were identified using LC-MS assay for buprenorphine under acidic, basic, and peroxide conditions. Stability study of oral buprenorphine syringes showed no precipitation, cloudiness, or color change during this study at all storage conditions. The LC-MS assay revealed that buprenorphine oral syringes retained greater than 90% of the initial concentrations for 30 days. CONCLUSIONS Highly sensitive stability-indicating LC-MS method was developed for studying the stability of extemporaneously compounded buprenorphine oral syringes. This study demonstrates that buprenorphine extemporaneous formulation prepared according to the manufacturers' recommendations is stable under refrigerated or room temperature conditions for 30 days in oral plastic syringes.

scholarly journals Effect on Insulin upon Storage in Extreme Climatic Conditions (Temperature and Pressure) and Their Preventive Measures

2019 ◽  
Vol 07 (01) ◽  
pp. 006-010 ◽  
Author(s):  
Girish Khurana ◽  
Vipul Gupta
Keyword(s):  
Storage Condition ◽  
Storage Conditions ◽  
Climatic Changes ◽  
Climatic Conditions ◽  
The Body ◽  
Naturally Occurring ◽  
Temperature And Pressure ◽  
The Stability ◽  
And Storage

AbstractInsulin is a naturally occurring hormone secreted by the pancreas. Insulin is required by the body cellsto remove and use glucose from the blood. The insulin and its various analogues are essential in management of type 1 diabetes mellitus. This study has been done to analyze how variation in various storage conditions and climatic changes causes change in therapeutic efficacy. Storage condition affects the stability of insulin as observed in a study in which insulin stored at temperature between 32 and 37°C showed 14 to 18% decrease in its potency and could not cause a significant decrease in blood sugar level when compared with those receiving insulin stored at 5°C. This work was done with the aim of finding the effect of climatic changes and storage condition on efficacy of insulin.

Optical Stability of High-translucency Resin-based Composites

2019 ◽  
Vol 44 (5) ◽  
pp. 536-544
Author(s):  
YB Piccoli ◽  
VP Lima ◽  
GR Basso ◽  
VE Salgado ◽  
GS Lima ◽  
...  
Keyword(s):  
Optical Properties ◽  
Calculated Data ◽  
Color Difference ◽  
Storage Condition ◽  
Color Variation ◽  
Dental Resin ◽  
Large Variability ◽  
Color Differences ◽  
Color System ◽  
The Stability

SUMMARY This study investigated the stability of the optical properties of high-translucent shades of dental resin-based composites. Four commercial materials (Filtek Z350 XT, Opallis, Amelogen Plus, and IPS Empress Direct) and 14 non-Vita shades were tested. Disc-shaped specimens for each resin-based composite-shade combination (n=6) were evaluated at T0 (baseline), T1 (after 30 days of storage in water), and T2 (after 30 days of storage each in water and a coffee solution). Color measurements were performed according to the L′C′h′ color system. Translucency Parameter (TP) and CIEDE2000 color difference (ΔE00) were calculated. Data were statistically analyzed at α = 0.05. Baseline TP values varied from 43 ± 1 to 55 ± 1. Changes in TP at T1 varied from −3.0% (Opallis T-Neutral) to 4.2% (Amelogen Plus Trans Orange), with no major differences from T0. At T2, most resin-based composites showed significantly increased opacity, with changes varying between −15.0% (Empress Direct Trans 20) and −2.7% (Z350 XT Blue). However, the TP values were ≥40 throughout the study. Storage in water caused negligible color differences, with ΔE00 values at T1 ≤ 0.9 ± 0.6. At T2, all materials tested showed significant color difference, and ΔE00 ≥ 3.2 ± 0.2. The orange shades from Opallis and Amelogen Plus showed lower color variation than did the other shades. The most significant optical changes upon storage were detected in the hue and particularly the chroma color coordinate. In conclusion, the high-translucent resin-based composites showed large variability in the stability of their optical properties among the tested brands and different shades of the same material. Regardless of the storage condition, the tested resin-based composites retained their high-translucency character over time.

The Usage of Treated Plastic as Additive to Improve the Asphalt Mixture’s Performance by Using Dry Mix Method

2021 ◽  
Vol 879 ◽  
pp. 126-135
Author(s):  
Siti Nur Naqibah Kamarudin ◽  
Mohd Rosli Hainin ◽  
Muhammad Naqiuddin Mohd Warid ◽  
Mohd Khairul Idham Mohd Satar ◽  
Ramadhansyah Putra Jaya
Keyword(s):  
Resilient Modulus ◽  
Asphalt Mixture ◽  
Fatigue Cracking ◽  
Traffic Load ◽  
Polymer Additive ◽  
Percent Improvement ◽  
Plastic Bag ◽  
The Stability ◽  
The Cost ◽  
Marshall Stability

Nowadays, road damage issue become the norm due to increment of traffic load and traffic volume. It shortens the service life of asphalt mixtures and increase the cost of maintenance. One way to reduce the issue is by using polymer additive in asphalt mixture. Treated Plastic is one type of polymer additive made of plastic bag (Polyethylene). The main purpose of this research is to determine the improvement of asphalt mixture’s performance incorporating Treated Plastic (TP) as additive in terms of stability, stiffness, fatigue cracking, stripping and rutting. The mechanical properties of asphalt mixes that include various percentages of TP (0%, 0.25%, 0.5%, 0.75%, 1%, 2% and 3%) were calculated and assessed with laboratory tests. 0.75% by weight of total mix of TP was found to be the optimum amount. The outcomes were analyzed by Marshall Stability and Flow, Resilient Modulus, Tensile Strength Ratio and Hamburg Wheel Tracker test. As the results shown, the addition of TP gave significant improvement to the stability and stiffness of asphalt mixture. 0.75% of TP was selected as the optimum percent content with percent improvement about 100, 73 and 25% for fatigue cracking, rutting and stripping resistance respectively. Hence, 0.75% of TP improved the resistance of rutting and stripping but susceptible to fatigue cracking.

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