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>

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.

Effects of syringe material and temperature and duration of storage on the stability of equine arterial blood gas variables

2004 ◽  
Vol 31 (4) ◽  
pp. 250-257 ◽  
Author(s):  
Joanne C Deane ◽  
Mark P Dagleish ◽  
Agnes E M Benamou ◽  
Basil T Wolf ◽  
David Marlin
Keyword(s):  
Blood Gas ◽  
Arterial Blood Gas ◽  
Arterial Blood ◽  
Duration Of Storage ◽  
The Stability

Influence of elemental impurities in aluminum hydroxide adjuvant on the stability of inactivated Japanese Encephalitis vaccine, IXIARO®

Vaccine ◽  
2015 ◽  
Vol 33 (44) ◽  
pp. 5989-5996 ◽  
Author(s):  
Robert Schlegl ◽  
Michael Weber ◽  
Jürgen Wruss ◽  
Donald Low ◽  
Kirsten Queen ◽  
...  
Keyword(s):  
Aluminum Hydroxide ◽  
Japanese Encephalitis ◽  
Elemental Impurities ◽  
Japanese Encephalitis Vaccine ◽  
The Stability

scholarly journals Effect of temperature and duration of storage on the stability of polyfluoroalkyl chemicals in human serum

Chemosphere ◽  
2013 ◽  
Vol 91 (2) ◽  
pp. 115-117 ◽  
Author(s):  
Kayoko Kato ◽  
Lee-Yang Wong ◽  
Brian J. Basden ◽  
Antonia M. Calafat
Keyword(s):  
Human Serum ◽  
Effect Of Temperature ◽  
Duration Of Storage ◽  
The Stability

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 &gt;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).

Mathematical Modeling and Stability Analysis of Japanese Encephalitis

2020 ◽  
Vol 12 (1) ◽  
pp. 120-127
Author(s):  
Vinod Baniya ◽  
Ram Keval
Keyword(s):  
Mathematical Modeling ◽  
Japanese Encephalitis ◽  
Disease Transmission ◽  
Equilibrium Points ◽  
Numerical Verification ◽  
Transmission Potential ◽  
Dynamical Behaviors ◽  
Proposed Model ◽  
The Stability ◽  
Stability Issues

Mathematical modeling of Japanese encephalitis (JE) disease in human population with pig and mosquito has been presented in this paper. The proposed model, which involves three compartments of human (Susceptible, Vaccinated, Infected), two compartments of mosquito (Susceptible, Infected) and three compartments of the pig (Susceptible, Vaccinated, Infected). In this work, it is assumed that JE spreads between susceptible class and infected mosquitoes only. Basic results like boundedness of the model, the existence of equilibrium and local stability issues are investigated. Here, to measure the disease transmission potential in the population the basic reproduction number (R0) from the system has been analyzed w.r.t. control parameters both numerically and theoretically. The dynamical behaviors of the system have been analyzed by using the stability theory of differential equations and numerical simulations at equilibrium points. A numerical verification of results is carried out of the model under consideration.

Immunological equivalence between mouse brain-derived and Vero cell-derived Japanese encephalitis vaccines

2006 ◽  
Vol 121 (2) ◽  
pp. 152-160 ◽  
Author(s):  
Motoharu Abe ◽  
Kouichi Shiosaki ◽  
Lena Hammar ◽  
Kengo Sonoda ◽  
Li Xing ◽  
...  
Keyword(s):  
Vero Cell ◽  
Mouse Brain ◽  
Japanese Encephalitis

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 Literature Review Uji Evaluasi Sediaan Krim

2020 ◽  
Vol 4 (2) ◽  
pp. 108
Author(s):  
Neneng Sri Purwaningsih ◽  
Siti Novy Romlah ◽  
Ayu Choirunnisa
Keyword(s):  
Literature Review ◽  
General Purpose ◽  
Homogeneity Test ◽  
Test Results ◽  
Test Standards ◽  
Organoleptic Test ◽  
Library Research ◽  
Test Review ◽  
The Stability ◽  
Good Homogeneity

The format of preparation cosmetic in a cream form is still popular in Indonesia, especially for the women. Because its easier to applied, and more comfortable. Literature review of evaluation cream preparation test is to compare the results of cream evaluation preparation from the previous researches, in order to get the best test results and accordance with specified conditions. The general purpose of this research is to know the results of Literature review of evaluation cream preparation test from several journals. Method This research is qualitative research which is Library research Cream evaluation preparation is a Parameters that have been established to determine the stability of cream preparation including organoleptic test, pH test, homogeneity test, type cream test, viscosity test, and scattering test. From the result of organoleptic test, pH test, viscosity test and scattering test review have the results partial test standards, and some doesn’t. this is due to the temperature factor, excessive extract concentration and chemical reaction at the time of storage is accelerated. Whereas at the results of homogeneity test have a quite good homogeneity, and in a type cream test has A/M and M/A type cream.Keywords:Evaluation of cream preparationOrganoleptic testpH testHomogenity testType cream test ABSTRAK Bentuk sediaan kosmetik berupa krim sampai saat ini masih banyak digemari oleh masyarakat Indonesia khususnya kaum wanita karena lebih mudah diaplikasikan, lebih nyaman digunakan. Literatur Review Uji Evaluasi Sediaan Krim adalah untuk membandingkan hasil evaluasi sediaan krim dari penelitian-penelitian sebelumnya agar mendapatkan hasil uji yang terbaik dan sesuai dengan ketentuan yang telah ditetapkan. Tujuan Umum dari penelitian ini adalah untuk mengetahui hasil Literatur Review uji evaluasi sediaan krim dari berberapa jurnal. Metode Penelitian ini adalah penelitian kualitatif yang bersifat studi pustaka (library research) yang menggunakan buku-buku dan literatur-literatur lainnya sebagai objek yang utama. Evaluasi sediaan krim adalah parameter yang telah ditetapkan untuk mengetahui kestabilan sediaan krim diantaranya uji organoleptik, uji homogenitas, uji pH, uji tipe krim, uji viskositas, dan uji Daya sebar. Hasil review uji organoleptik, pH, viksositas dan daya sebar memiliki hasil sebagian memenuhi standar uji, dan sebagian tidak memenuhi standar uji yang telah ditetapkan. Hal ini dikarenakan faktor suhu, konsentrasi ekstrak yang berlebih serta reaksi kimia pada saat penyimpanan dipercepat. Sedangkan pada hasil uji homogenitas secara keseluruhan jurnal yang diuji memiliki homogenitas yang cukup baik, serta uji tipe krim yaitu memiliki tipe krim A/M dan M/AKata Kunci:Evaluasi sediaan krimUji organoleptikUji pHUji homogenitasUji tipe krim

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