低分子量肝素用于分子量校准(第二国际标准)
| 【编号】：NIBSC05/112 【产品名称】：低分子量肝素用于分子量校准(第二国际标准) 【规格】：个 【价格】：2600元   低分子量肝素用于分子量校准(第二国际标准)
编号：NIBSC05/112
英文：Low Molecular Weight Heparin for Molecular Weight Calibration (2nd International Standard).
标准类型：国际标准
规格：1个
描述：1. INTENDED USE
The 2nd International Standard Low Molecular Weight Heparin for
Molecular Weight Calibration consists of ampoules, coded 05/112,
containing aliquots of a freeze-dried material prepared from porcine
mucosa. This preparation was established as the 2nd International
Standard Low Molecular Weight Heparin for Molecular Weight Calibration
by the Expert Committee on Biological Standardisation of the World
Health Organisation in 2007
2. CAUTION
This preparation is not for administration to humans or animals in
the human food chain.
The material is not of human or bovine origin. As with all materials of
biological origin, this preparation should be regarded as potentially
hazardous to health. It should be used and discarded according to
your own laboratory's safety procedures. Such safety procedures
should include the wearing of protective gloves and avoiding the
generation of aerosols. Care should be exercised in opening
ampoules or vials, to avoid cuts.
3. UNITAGE
There is no assigned unitage associated with this standard. The standard
was calibrated by 15 laboratories in 10 countries, against the 1st
International Reference Reagent Low Molecular Weight Heparin for
Molecular Weight Calibration (1). It is characterised by the Table in
Appendix 1.
4. CONTENTS
Country of origin of biological material: Denmark.
In June 2005 , 251.3 mg bulk material was dissolved in 10 litres water for
injection. The solution was distributed at 4°C into 10000 ampoules (CV for
volume of fill 0.15% (n=136)), coded 05/112. The contents of the
ampoules were then freeze-dried under the conditions normally used for
international biological standards. The mean dry weight (n=6) of the
freeze-dried plug was 23.5 mg, with a water content of 0.29%.
5. STORAGE
Unopened ampoules should be stored in the dark at or below –20°C.
Please note: because of the inherent stability of lyophilized
material, NIBSC may ship these materials at ambient temperature.
6. DIRECTIONS FOR OPENING
DIN ampoules have an 'easy-open' coloured stress point, where the
narrow ampoule stem joins the wider ampoule body. Various types of
ampoule breaker are available commercially. To open the ampoule,
tap the ampoule gently to collect material at the bottom (labelled) end
and follow manufactures instructions provided with the ampoule
breaker.
7. USE OF MATERIAL
No attempt should be made to weigh out any portion of the freeze-dried
material prior to reconstitution
The calibrant is intended for use in the determination of the molecular
weight distribution of low molecular weight heparins by size exclusion
chromatography (SEC, also sometimes known as gel permeation
chromatography (GPC)). It may be used to calibrate a chromatography
system by broad standard calibration (as has been described for the
previous calibrant (2)), using the molecular weight distribution information
as listed in the table in Appendix 1. For each molecular weight (M) in theTable, the percent of sample above M (%>M) and the percent of sample
below M (%<M) are given. The use of specialised SEC computer software
for calibration of the chromatography system and for calculation of the
molecular weights of low molecular weight heparin samples is strongly
recommended. It should be noted that the 2nd International Standard Low
Molecular Weight Heparin for Molecular Weight Calibration is not suitable for
use in the method of Nielsen (3).
8. STABILITY
Reference materials are held at NIBSC within assured, temperaturecontrolled
storage facilities. Reference Materials should be stored on
receipt as indicated on the label.
NIBSC follows the policy of WHO with respect to its reference materials.
It is the policy of the WHO not to assign an expiry date to their
international reference materials. They remain valid with the assigned
potency and status until withdrawn or ammended.
Accelerated degradation studies, which involves potency estimation of
ampoules stored at elevated temperatures relative to ampoules stored on
liquid nitrogen vapour (approx. -150°C) for this preparation have, to date
shown no loss in activity. The accelerated degradation study and real
time monitoring will continue for the lifetime of the standard.
9. REFERENCES
1. Mulloy B, Heath A, Behr-Gross ME (2007) Pharmeuropa Bio 2007(1):
29-48
2. Mulloy B, Gee C, Wheeler SF, Wait R, Gray E, Barrowcliffe TW (1997)
Thrombosis and Haemostasis 77, 668-674
3. Nielsen JI, (1992) Thrombosis and Haemostasis 68, 478-480
10. ACKNOWLEDGEMENTS
Acknowledgements are made to the joint organisers of the collaborative
study at the European Directorate for the Quality of Medicines, in particular
to the study co-ordinator Dr M.-E. Behr-Gross, as well as to the participants
in the study. We also thank the donors of the bulk material for this standard,
Leo Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.
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