The Stability of the WHO Reference Thromboplastin NIBS & C 67/40

1979 ◽  
Vol 42 (04) ◽  
pp. 1135-1140 ◽  
Author(s):  
G I C Ingram
Keyword(s):  
Human Brain ◽  
Collaborative Study ◽  
Calibration Constant ◽  
Long Term Stability ◽  
Freeze Dried ◽  
Show Evidence ◽  
Human Material ◽  
Reference Preparation ◽  
The Stability

SummaryThe International Reference Preparation of human brain thromboplastin coded 67/40 has been thought to show evidence of instability. The evidence is discussed and is not thought to be strong; but it is suggested that it would be wise to replace 67/40 with a new preparation of human brain, both for this reason and because 67/40 is in a form (like Thrombotest) in which few workers seem to use human brain. A �plain� preparation would be more appropriate; and a freeze-dried sample of BCT is recommended as the successor preparation. The opportunity should be taken also to replace the corresponding ox and rabbit preparations. In the collaborative study which would be required it would then be desirable to test in parallel the three old and the three new preparations. The relative sensitivities of the old preparations could be compared with those found in earlier studies to obtain further evidence on the stability of 67/40; if stability were confirmed, the new preparations should be calibrated against it, but if not, the new human material should receive a calibration constant of 1.0 and the new ox and rabbit materials calibrated against that.The types of evidence available for monitoring the long-term stability of a thromboplastin are discussed.

Standardization of Factor VIII – III. Establishment of a Stable Reference Plasma for Factor VIII-Related Activities

1983 ◽  
Vol 50 (03) ◽  
pp. 690-696 ◽  
Author(s):  
T W Barrowcliffe ◽  
M S Tydeman ◽  
T B L Kirkwood ◽  
D P Thomas
Keyword(s):  
Factor Viii ◽  
Collaborative Study ◽  
Expert Committee ◽  
Normal Plasma ◽  
Freeze Dried ◽  
Biological Standardization ◽  
Reference Preparation ◽  
The One ◽  
Good Agreement

SummaryAn international collaborative study has been carried out to establish a reference plasma for Factor VIII-related activities. The freeze-dried reference plasma, coded 80/511, was assayed against fresh normal plasma, local standards and another freeze- dried plasma. There was good agreement between laboratories for the comparison of the two freeze-dried plasmas, but wide variation in the comparison of plasma 80/511 with fresh normal plasma and local standards, indicating the differences in Factor VIII content of local pooled plasmas. There were no significant differences between the one-stage and two-stage assays of VIII :C, or between electroimmunoassay (EIA) and immuno- radiometric (IRMA) assays of VIII R:Ag. However, in VIII R: RCoF (ristocetin co-factor) assays, the aggregometry methods gave lower values than the macroscopic and counting methods for the comparison of freeze-dried against fresh normal plasmas. From the combined results of assays against each laboratory’s fresh normal plasma, potencies were assigned to plasma 80/511.Results from accelerated degradation studies indicated that losses of each VIII-related activity in plasma 80/511, when stored at -20° C, should be less than 0.01% per year, indicating its suitability to serve as a long-term reference preparation. Plasma 80/511 has been established by the WHO Expert Committee on Biological Standardization as the 1st International Reference Preparation for Factor VIII-Related Activities in Plasma.

Multi-Center Calibration of the Third BCR Reference Material for Thromboplastin, Rabbit, Plain, Coded CRM 149S

1995 ◽  
Vol 74 (06) ◽  
pp. 1465-1467 ◽  
Author(s):  
A M H P van den Besselaar
Keyword(s):  
Reference Material ◽  
Collaborative Study ◽  
Sensitivity Index ◽  
Term Stability ◽  
Long Term Stability ◽  
Reference Preparation ◽  
The Mean ◽  
The Relationship ◽  
International Sensitivity Index

SummaryIn a collaborative study by eleven laboratories performed within the framework of the European Community Bureau of Reference (BCR), a third reference material for thromboplastin, rabbit, plain, has been calibrated against RBT/90, the current WHO international reference preparation for thromboplastin, rabbit, plain. This third reference material (coded CRM 149S) has a mean International Sensitivity Index (ISI)of 1.257 with a standard error of the mean of 0.013.The previous BCR reference material for thromboplastin, rabbit, plain (coded CRM 149R) and the reference material for thromboplastin, bovine, combined (coded OBT/79) were also included in the trial for assessment of the long-term stability of the ISI values. The relationship between ISI values determined in the present study was nearly identical to that of the historical values. These results offer reassurance with regard to the long-term stability of these reference materials.

scholarly journals Limitations and Challenges in the Stability of Cysteamine Eye Drop Compounded Formulations

2021 ◽  
Vol 15 (1) ◽  
pp. 2
Author(s):  
Cristina Martín-Sabroso ◽  
Mario Alonso-González ◽  
Ana Fernández-Carballido ◽  
Juan Aparicio-Blanco ◽  
Damián Córdoba-Díaz ◽  
...  
Keyword(s):  
Shelf Life ◽  
Stability Study ◽  
Eye Drops ◽  
Microbiological Analysis ◽  
Nitrogen Gas ◽  
Long Term Stability ◽  
Main Degradation Product ◽  
The Stability ◽  
Unstable Molecule

Accumulation of cystine crystals in the cornea of patients suffering from cystinosis is considered pathognomonic and can lead to severe ocular complications. Cysteamine eye drop compounded formulations, commonly prepared by hospital pharmacy services, are meant to diminish the build-up of corneal cystine crystals. The objective of this work was to analyze whether the shelf life proposed for six formulations prepared following different protocols used in hospital pharmacies is adequate to guarantee the quality and efficacy of cysteamine eye drops. The long-term and in-use stabilities of these preparations were studied using different parameters: content of cysteamine and its main degradation product cystamine; appearance, color and odor; pH and viscosity; and microbiological analysis. The results obtained show that degradation of cysteamine was between 20% and 50% after one month of storage in the long-term stability study and between 35% and 60% in the in-use study. These data confirm that cysteamine is a very unstable molecule in aqueous solution, the presence of oxygen being the main degradation factor. Saturation with nitrogen gas of the solutions offers a means of reducing cysteamine degradation. Overall, all the formulae studied presented high instability at the end of their shelf life, suggesting that their clinical efficacy might be dramatically compromised.

LONG-TERM STABILITY ANALYSIS OF ACOUSTIC ABSORBING BOUNDARY CONDITIONS

2013 ◽  
Vol 23 (11) ◽  
pp. 2129-2154 ◽  
Author(s):  
HÉLÈNE BARUCQ ◽  
JULIEN DIAZ ◽  
VÉRONIQUE DUPRAT
Keyword(s):  
Stability Analysis ◽  
Boundary Conditions ◽  
Absorbing Boundary Conditions ◽  
Computational Domain ◽  
Acoustic Wave Equation ◽  
Absorbing Boundary ◽  
Term Stability ◽  
Long Term Stability ◽  
The Stability

This work deals with the stability analysis of a one-parameter family of Absorbing Boundary Conditions (ABC) that have been derived for the acoustic wave equation. We tackle the problem of long-term stability of the wave field both at the continuous and the numerical levels. We first define a function of energy and show that it is decreasing in time. Its discrete form is also decreasing under a Courant–Friedrichs–Lewy (CFL) condition that does not depend on the ABC. Moreover, the decay rate of the continuous energy can be determined: it is exponential if the computational domain is star-shaped and this property can be illustrated numerically.

A Review of Preparation and Tribological Applications of Pickering Emulsion

2021 ◽  
pp. 1-27
Author(s):  
Yichen Bao ◽  
Kai Liu ◽  
Quan Zheng ◽  
Lulu Yao ◽  
Yufu Xu
Keyword(s):  
Pickering Emulsion ◽  
Solid Particles ◽  
Preparation Methods ◽  
Factors Affecting ◽  
Long Term Stability ◽  
New Strategy ◽  
New Type ◽  
The Stability ◽  
Near Future

Abstract Pickering emulsion is a new type of stable emulsion made by ultra-fine solid particles instead of traditional surfactants as stabilizers, which has received widespread attention in recent years. The preparation methods of stator-rotor homogenization, high-pressure homogenization, and ultrasonic emulsification were compared with others in this work. The main factors affecting the stability of Pickering emulsion are the surface humidity of the solid particles, the polarity of the oil phase, and the oil-water ratio. These factors could affect the nature of the solid particles, the preparation process of Pickering emulsion and the external environment. Consequently, the long-term stability of Pickering emulsion is still a challenge. The tribological investigations of Pickering emulsion were summarized, and the multifunctional Pickering emulsion shows superior prospects for tribological applications. Moreover, the latest development of Pickering emulsion offers a new strategy for smart lubrication in the near future.

Stability of a Piezoresistive Ceramic Pressure Sensor Made With LTCC Technology

2012 ◽  
Vol 2012 (CICMT) ◽  
pp. 000371-000376 ◽  
Author(s):  
Marina Santo Zarnik ◽  
Darko Belavic
Keyword(s):  
Pressure Sensor ◽  
Fatigue Testing ◽  
Low Pressure ◽  
Fatigue Tests ◽  
Point Of View ◽  
Long Term Stability ◽  
Pressure Cycling ◽  
Key Characteristics ◽  
The Stability

This paper discusses the stability of a piezoresistive, LTCC-based, pressure sensor that was designed for measurements in a low-pressure range below 100 mbar. The intrinsic stability of the sensor's offset was evaluated at a constant ambient temperature and different conditions regarding the atmospheric humidity. The sensors were also subjected to functional fatigue tests, which included a full-scale and an overload pressure cycling. The results of the fatigue testing revealed the vulnerability of the sensor's structure from the point of view of the long-term stability and the life-cycle. Nevertheless, the stability of the key characteristics of the prototype sensors was found to be satisfactory for accurate measurements in the low-pressure ranges.

Fabrication of Boron Compensated Hydrogenated Amorphous Silicon Films with Significantly Improved Stability Using Plasma Enhanced Chemical Vapor Deposition Technique

1995 ◽  
Vol 377 ◽  
Author(s):  
Mohan K. Bhan
Keyword(s):  
Chemical Vapor ◽  
Short Term ◽  
Term Stability ◽  
Long Term Stability ◽  
Vapor Deposition Technique ◽  
Improved Stability ◽  
Donor Acceptor ◽  
B Doping ◽  
The Stability

ABSTRACTWe have systematically investigated the effects of addition of sub-ppm levels of boron on the stability of a-Si:H films and p-i-n devices, deposited by PE-CVD technique. The films thus produced with appropriate amounts of boron, show a significant improvement in stability, when soaked under both AM 1.5 (short-term) as well as 10×sun (long-term) illumination conditions. The opto-electronic properties of the films are quite respectable It is concluded that boron compensates the native impurities by forming donor-acceptor pairs, which reduces the “fast” defects and hence the initial degradation of the films. It is also speculated that boron may also be improving the short-term stability, by reducing the recombination of light generated electrons and holes, by converting D° into D+ states. The long-term stability appears to get affected by hydrogen dilution which seems to reduce the amount of “slow” defects. As a result of B doping of i-layer, the initial conversion efficiency of the devices decreases. It is presumed that our devices may contain an enhanced level of boron impurity, than expected, making them as worse material and to degrade less.

THE FIRST INTERNATIONAL STANDARD FOR HUMAN URINARY FSH AND FOR HUMAN URINARY LH (ICSH), FOR BIOASSAY

1976 ◽  
Vol 83 (4) ◽  
pp. 700-710 ◽  
Author(s):  
P. L. Storring ◽  
H. Dixon ◽  
D. R. Bangham
Keyword(s):  
Elevated Temperatures ◽  
Collaborative Study ◽  
Storage Conditions ◽  
Working Standard ◽  
International Standard ◽  
Accelerated Degradation ◽  
Reference Preparation ◽  
Degradation Studies ◽  
The Stability ◽  
Working Standards

ABSTRACT This paper describes the preparation and nature of the First International Standard for Human Urinary Follicle Stimulating Hormone and for Human Urinary Luteinizing Hormone, for Bioassay, and of two batches of working standard which were prepared from the same material. A collaborative study of these materials was carried out by six laboratories in six different countries. The FSH and LH activities of the Standard were assayed in terms of those of the Second International Reference Preparation of Human Menopausal Gonadotrophins, Urinary, for Bioassay, which it replaces. The results from 20 valid FSH assays and 30 valid LH assays (using four different methods) obtained in this way gave a weighted combined potency estimate for FSH of 53.7 IU, with 95 fiducial limits of 47.2–61.1 IU, and for LH of 46.2 IU, with 95% fiducial limits of 43.3–49.3 IU. Accelerated degradation studies of the Standard stored at elevated temperatures suggested that the stability of both FSH and LH activities under normal storage conditions would be satisfactory. The FSH and LH activities of the two batches of working standard (WS-A and WS-B) were compared with those of the Standard and were not found to differ significantly, except for the LH activity of WS-B which appeared to be slightly higher than that of the Standard. Accelerated degradation studies did not show any significant differences in stability between the Standard and batches of working standards. On the basis of these results the Standard has been established by WHO and allocated a potency for FSH of 54 IU per ampoule and for LH 46 IU per ampoule. The International Units for FSH, Human Urinary, for Bioassay and for LH (ICSH), Human Urinary, for Bioassay are thus defined as the activities contained in 0.11388 mg and 0.13369 mg of the International Standard, respectively.

scholarly journals Evaluation of long-term stability of mesiodistal axial inclinations of maxillary molars through panoramic radiographs in subjects treated with Pendulum appliance

2016 ◽  
Vol 21 (1) ◽  
pp. 67-74 ◽  
Author(s):  
Caroline Andrade Rocha ◽  
Renato Rodrigues de Almeida ◽  
José Fernando Castanha Henriques ◽  
Carlos Flores-Mir ◽  
Marcio Rodrigues de Almeida
Keyword(s):  
Panoramic Radiograph ◽  
Post Treatment ◽  
Control Group ◽  
Long Term Stability ◽  
Maxillary Molars ◽  
Group Data ◽  
Maxillary Molar ◽  
Pendulum Appliance ◽  
The Stability

Objective: To evaluate the stability of mesiodistal inclination of maxillary molars produced by a pendulum appliance, five years after completion of orthodontic treatment. Angulation changes were compared to an untreated sample. Methods: The sample consisted of 20 patients (14 females and 6 males) with Class II, Division 1 malocclusion that was treated through molar distalization with a pendulum appliance followed by cervical headgear and full fixed appliances. Maxillary molar inclination was evaluated through panoramic radiograph. The mean age at pretreatment was 14.3 ± 1.6 years, whereas at immediate post-treatment it was 18.6 ± 1.8 years, and at long-term post-treatment it was 23.8 ± 2.0 years. A control group of 16 untreated individuals with untreated normocclusion ranging in age from 12 to 17 years old were used as comparison group. Data were statistically analyzed with independent t-tests and ANOVA test followed by Tukey post-hoc tests. Results: Statistically significant differences were found between T1 (94.50) and T2 (98.80) as well as between T2 and T3 (94.70) for maxillary first molars. Maxillary second molars did not show any statistically significant positional changes during the evaluated time periods T1 (107.50), T2 (109.30) and T3 (106.90). Conclusion: Although maxillary first molars underwent distal crown inclination immediately after treatment, approximately five years thereafter their roots tended to upright close to the pretreatment positions.

scholarly journals Long-Term Stability Comparison between an Original and a Generic Version of Piperacillin/Tazobactam in Dextrose 5 % Infusion Polyolefin Bags at 5 ± 3 °C after Microwave Freeze-Thaw Treatment

2018 ◽  
Vol 3 (3) ◽  
pp. 143-151
Author(s):  
Sophie Huvelle ◽  
Marie Godet ◽  
Laurence Galanti ◽  
Mélanie Closset ◽  
Benoît Bihin ◽  
...  
Keyword(s):  
Generic Version ◽  
Generic Product ◽  
Brand Name ◽  
Term Stability ◽  
Long Term Stability ◽  
Ph Values ◽  
Lower Confidence ◽  
The Stability ◽  
Aseptic Conditions

AbstractBackgroundPiperacillin-Tazobactam is frequently infused in hospitals. The use of a generic version was considered after the out of stock of the brand name Tazocin®. The stability of 4 g of Tazocin®in 120 mL of dextrose 5 % (D5) was demonstrated during 35 days at 5 °C ± 3 °C after freezing (−20 °C) and microwave thawing (FMT). The aim of the study was to investigate and compare the long-term stability of Tazocin®and a generic product in the same conditions.MethodsFive polyolefin bags of 4 g of Piperacillin/Tazobactam®Sandoz and 5 bags of 4 g of Tazocin®were prepared under aseptic conditions in 120 mL of D5 and stored 3 months at 20 °C then thawed and stored 58 days at 5 ± 3 °C.Spectrophotometric absorbance at different wavelengths, pH measurement, visual and microscopic observations were also performed.The concentrations were measured by HPLC, at 211 nm for tazobactam and 230 nm for piperacilline.ResultsNo significant change in pH values or optic densities, no crystals were detected. The lower confidence limit at 95 % of the concentration for the solutions remains superior to 90 % of the initial concentration until 58 days of storage at 5 ± 3 °C.ConclusionUnder these conditions, 4 g/120 mL of Piperacillin/Tazobactam®Sandoz or Tazocin®in D5 infusion in polyolefin bags remains stable at least for 58 days at 5 ± 3 °C after FMT

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