低分子量肝素用于分子量校準(zhǔn)(第二國(guó)際標(biāo)準(zhǔn))

??【編號(hào)】：NIBSC05/112

??【產(chǎn)品名稱】：低分子量肝素用于分子量校準(zhǔn)(第二國(guó)際標(biāo)準(zhǔn))

??【規(guī)格】：個(gè)

??【價(jià)格】：2600元

　　低分子量肝素用于分子量校準(zhǔn)(第二國(guó)際標(biāo)準(zhǔn))

　　編號(hào)：NIBSC05/112

　　英文：Low Molecular Weight Heparin for Molecular Weight Calibration (2nd International Standard).

　　標(biāo)準(zhǔn)類型：國(guó)際標(biāo)準(zhǔn)

　　規(guī)格：1個(gè)

　　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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