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 International collaborative study to evaluate a recombinant L ferritin preparation as an International Standard

1997 ◽  
Vol 43 (9) ◽  
pp. 1582-1587 ◽  
Author(s):  
Susan J Thorpe ◽  
Dawn Walker ◽  
Paolo Arosio ◽  
Alan Heath ◽  
James D Cook ◽  
...  
Keyword(s):  
Collaborative Study ◽  
Expert Committee ◽  
Immunological Reactivity ◽  
International Standard ◽  
Accelerated Degradation ◽  
Wide Range ◽  
Biological Standardization ◽  
International Collaborative ◽  
Degradation Studies ◽  
International Collaborative Study

Abstract A recombinant L ferritin preparation, lyophilized in ampoules and designated 94/572, was evaluated by 18 laboratories in 9 countries for its suitability as an International Standard (IS). The preparation was assayed in a wide range of in-house and commercial immunoassays against the 2nd IS for ferritin (of spleen origin; 80/578). The immunological reactivity of the recombinant material was similar to that of the 2nd IS for ferritin in the majority of assays and demonstrated adequate stability in accelerated degradation studies. On the basis of the results presented here, the WHO Expert Committee on Biological Standardization established 94/572 as the 3rd IS for ferritin, recombinant.

INTERNATIONAL COLLABORATIVE STUDY OF N.I.B.S.C. RESEARCH STANDARD FOR HUMAN PARATHYROID HORMONE FOR IMMUNOASSAY

1980 ◽  
Vol 86 (2) ◽  
pp. 291-304 ◽  
Author(s):  
JOAN M. ZANELLI ◽  
ROSE E. GAINES DAS
Keyword(s):  
Parathyroid Hormone ◽  
Biological Activities ◽  
Collaborative Study ◽  
Human Parathyroid Hormone ◽  
In Vitro Bioassay ◽  
Accelerated Degradation ◽  
Reference Preparation ◽  
Working Standards ◽  
International Collaborative Study

The use of a Research Standard for human parathyroid hormone (PTH) in a collaborative study by 17 laboratories in ten countries is described. Results of this study showed that the Research Standard was not distinguishable by immunoreactive criteria from the other preparations and laboratory working standards of human PTH included in the study. It was, however, shown to be distinguishable from the International Reference Preparation for Parathyroid Hormone, Bovine, for Immunoassay by immunoreactive criteria and by heterogeneity of estimates in terms of bovine PTH. The Research Standard had appropriate biological activities in three different in-vitro bioassay systems and appeared to be stable under conditions of accelerated degradation. This material in ampoules coded 75/549 is now available internationally as N.I.B.S.C. Research Standard for human PTH for immunoassay.

A Collaborative Study to Establish the Second International Standard for Streptokinase

1990 ◽  
Vol 64 (02) ◽  
pp. 267-269 ◽  
Author(s):  
A B Heath ◽  
P J Gaffney
Keyword(s):  
High Purity ◽  
Collaborative Study ◽  
World Health Organisation ◽  
World Health ◽  
Clot Lysis ◽  
Current Standard ◽  
International Standard ◽  
Accelerated Degradation ◽  
The World ◽  
International Collaborative Study

SummaryAn International Standard for Streptokinase - Streptodomase (62/7) has been used to calibrate high purity clinical batches of SK since 1965. An international collaborative study, involving six laboratories, was undertaken to replace this standard with a high purity standard for SK. Two candidate preparations (88/826 and 88/824) were compared by a clot lysis assay with the current standard (62/7). Potencies of 671 i.u. and 461 i.u. were established for preparations A (88/826) and B (88/824), respectively.Either preparation appeared suitable to serve as a standard for SK. However, each ampoule of preparation A (88/826) contains a more appropriate amount of SK activity for potency testing, and is therefore preferred. Accelerated degradation tests indicate that preparation A (88/826) is very stable.The high purity streptokinase preparation, coded 88/826, has been established by the World Health Organisation as the 2nd International Standard for Streptokinase, with an assigned potency of 700 i.u. per ampoule.

A Collaborative Study to Establish an International Standard for Alpha-Thrombin

1992 ◽  
Vol 67 (04) ◽  
pp. 424-427 ◽  
Author(s):  
P J Gaffney ◽  
A B Heath ◽  
J W Fenton II
Keyword(s):  
Elevated Temperatures ◽  
Collaborative Study ◽  
World Health Organisation ◽  
Significant Loss ◽  
Thrombin Inhibitors ◽  
World Health ◽  
Expert Committee ◽  
International Standard ◽  
Assay Procedure ◽  
And Control

SummarySince 1975 an International Standard for Thrombin of low purity has been used. While this standard was stable and of value for calibrating thrombins of unknown potency the need for a pure a-thrombin standard arose both for accurate calibration and for precise measurement of thrombin inhibitors, notably hirudin. An international collaborative study was undertaken to establish the potency and stability of an ampouled pure a-thrombin preparation. A potency of 97.5 international units (95% confidence limits 86.5-98.5) was established for the new a-thrombin standard (89/ 588) using a clotting-assay procedure. Stability data at various elevated temperatures indicated that the standard could be transported and stored with no significant loss of potency.Ampoules of lyophilised a-thrombin (coded 89/588) have been recommended as an International Standard for a-thrombin with an assigned potency of 100 international units per ampoule by the International Society for Thrombosis and Haemostasis (Thrombin and its Inhibitors Sub-Committee) in Barcelona, Spain in July 1990 while the Expert Committee on Biological Standardisation and Control of the World Health Organisation will consider its status at its next meeting in Geneva in 1991.

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.

scholarly journals Thermal stability of amino acids in meals and feeds used in shrimp farming

Gaia Scientia ◽  
2016 ◽  
Vol 10 (4) ◽  
pp. 372-389
Author(s):  
João Paulo de Sousa Prado ◽  
José Marcelino Oliveira Cavalheiro ◽  
Thiago Brandão Cavalheiro ◽  
Fernanda Vanessa Gomes da Silva
Keyword(s):  
Amino Acids ◽  
Elevated Temperatures ◽  
Amino Acid Content ◽  
Storage Conditions ◽  
Shrimp Farming ◽  
Protein Levels ◽  
Commercial Feed ◽  
The Stability ◽  
The Right ◽  
And Control

The Brazilian shrimp farming uses mainly commercial feed for shrimp nutrition. This choice occurs because of the advantages related to convenience and good adaptation of Litopenaeus vannanmei to feed intake. Thus, the quality of feed is a determining factor for maximum performance of the shrimp farms, making the right selection of suppliers and control of the storage conditions as ways to prevent contamination and spoilage of feed. The objective of this study was to evaluate the stability of amino acids in meals and commercial feed with different protein levels, subjected to high-temperature storage. The samples were exposed to temperature of 50 oC and evaluated every 5 days for 30 days.The analyses of the degradation of amino acids were performed using an elution gradient in HPLC system.In evaluated meals it was observed that valine and arginine were the amino acids that suffered greater loss during the experiment and histidine and alanine suffered less degradation.Significant difference was observed in the content of all amino acids analyzed after exposure of the feed to the temperature of 50 oC; with reduce in values of its amino acid content. The results obtained in this study indicate that meals and feed exposed to elevated temperatures significantly reduced the content of its amino acids.

A Collaborative Study of Proposed European Pharmacopoeia Reference Preparations of Low Molecular Mass Heparin

1995 ◽  
Vol 74 (03) ◽  
pp. 893-899 ◽  
Author(s):  
E Gray ◽  
A B Heath ◽  
B Mulloy ◽  
J-M Spiese ◽  
T W Barrowcliffe
Keyword(s):  
Molecular Mass ◽  
Low Molecular Weight Heparin ◽  
Collaborative Study ◽  
Low Molecular Weight ◽  
European Pharmacopoeia ◽  
Response Curves ◽  
Working Standard ◽  
Assay Methods ◽  
European Collaborative Study ◽  
Working Standards

SummaryA European collaborative study, in which 16 laboratories participated, was carried out to assess the performance of the European Pharmacopoeia (EP) monograph methods for anticoagulant activities (anti-Xa and anti-IIa assays) of low molecular mass (EMM) heparin and to assess the suitability of six candidate materials as the EP working standard for LMM heparin. There was good interlaboratory agreement for both types of assays as indicated by most gcv’s being less than 10%, indicating acceptable performance of the EP assay methods. All the candidate preparations gave dose-response curves parallel to the 1st International Standard for Low Molecular Weight heparin and to each other. All preparations, possibly with the exception of E and F, gave similar performance as measured by interlaboratory agreement and would be suitable as working standards. Based on these data, preparations A, B, C and D have been established by the EP as official EP Biological Reference Preparations and they will be issued as successive batches.

Collaborative Study on Assays of Activated FIX (FIXa) On Behalf of the Factor VIII and Factor IX Subcommittee of the ISTH

1996 ◽  
Vol 76 (06) ◽  
pp. 1114-1117 ◽  
Author(s):  
Elaine Gray ◽  
Dawn Walker ◽  
Alan Heath ◽  
Trevor W Barrowcliffe
Keyword(s):  
Collaborative Study ◽  
Factor Ix ◽  
Test Material ◽  
Local Method ◽  
Degradation Study ◽  
Accelerated Degradation ◽  
Local Standard ◽  
Coefficients Of Variation ◽  
Reference Preparation

SummaryA collaborative study has been organised by NIBSC to examine the performance of FIXa assays between laboratories, and to investigate the need for a standard. Ampoules of 3 materials, one monocomponent concentrate (coded C) and 2 different preparations of purified human FIXa (one proposed reference preparation, coded A and a test material coded B), have been assayed in 11 laboratories for FIXa using either the NIBSC method or a local method, with local standards (if available, coded D) to determine their potencies. The data showed high between assay variability; with the exception of one laboratory, most of the between assay variation expressed as %geometric coefficients of variation (gcv) were over 15%The interlaboratory gcv when preparation B was assayed against the local standard was over 1700%, suggesting that most of the local standards are poorly calibrated. The %gcv was improved to 80% when reference A was used as the standard. These data clearly show that an international reference standard for FIXa would help to standardise FIXa preparations and would also improve in house assays for FIXa. However, an accelerated degradation study has shown that reference A is not suitable as a long term standard and another material with suitable stabilisers has to be established as an international standard for FIXa.

Establishment of the second international standards for porcine and human calcitonins: report of the international collaborative study

1993 ◽  
Vol 128 (5) ◽  
pp. 443-450 ◽  
Author(s):  
Joan M Zanelli ◽  
Rose E Gaines-Das ◽  
P Corran
Keyword(s):  
World Health Organization ◽  
Collaborative Study ◽  
International Standards ◽  
World Health ◽  
International Reference ◽  
International Standard ◽  
Reference Preparation ◽  
Health Organization ◽  
International Collaborative Study

The biological potency of calcitonins in clinical use in long-term treatment of Paget's disease of bone and, increasingly, in osteoporosis is usually expressed in international units defined by the relevant World Health Organization international reference preparation. The international reference preparations for porcine and human calcitonins were ampouled in 1970 and stocks are now exhausted. Replacement standards were ampouled in 1989 and have been evaluated and calibrated by an international collaborative study comprising 16 laboratories in 12 countries. Evaluations included high-performance liquid chromatography and in vitro bioassay; calibration of each new ampouled preparation in terms of its international reference preparation was by in vivo rat hypocalcaemia bioassay. On the basis of the results of the study and with the agreement of the participants, replacement standards were established by the Expert Committee on Biological Standardization of the World Health Organization in 1991: the international standard for porcine calcitonin (ampoule code 89/540), with an assigned potency of 0.8 international units per ampoule, and the international standard for human calcitonin, with an assigned potency of 17.5 international units per ampoule. Both international standards appeared to be sufficiently stable to serve as the international standards for in vivo biological assays. Comparison of the two species of calcitonin in the same hypocalcaemia assay showed that they were approximately equipotent when the doses were given intravenously but that the human peptide was four- to sixfold more potent than porcine calcitonin when doses were given subcutaneously, emphasizing the need to compare "like with like".

scholarly journals Influence of Different Sweeteners on the Stability of Anthocyanins from Cornelian Cherry Juice

Foods ◽  
2020 ◽  
Vol 9 (9) ◽  
pp. 1266
Author(s):  
Bianca Moldovan ◽  
Luminita David
Keyword(s):  
Deleterious Effect ◽  
Degradation Process ◽  
Storage Conditions ◽  
Biologically Active ◽  
Cornelian Cherry ◽  
Accelerated Degradation ◽  
Pigment Stability ◽  
Cherry Juice ◽  
The Stability ◽  
And Storage

Cornelian cherries are red fruits which can be considered as a valuable dietary source of antioxidant biologically active compounds, especially anthocyanins. The purpose of the present study was to investigate the anthocyanins degradation process in Cornelian cherry juice supplemented with different sweeteners. Four formulations of Cornelian cherry juice were prepared using different sugars (sucrose, fructose) or artificial sweeteners (aspartame and acesulfame potassium). The obtained juices were stored at three distinct temperatures (2 °C, 25 °C, and 75 °C) in order to evaluate the effects of the sweetener and storage conditions on the pigment stability. The rate constants (k) and the half time values (t1/2) of the degradation processes were determined. The highest stability was observed for the anthocyanins from the unsweetened juice stored at 2 °C (k = 0.5·10−3 h−1), while the most accelerated degradation was registered for the fructose sweetened juice stored at 75 °C (k = 91.65·10−3 h−1). The presence of the different sweeteners in the Cornelian cherry juice affects their pigment stability during storage. The highest change in the retention of anthocyanins was determined by the presence of fructose, while acesulfame potassium had the less deleterious effect.

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