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抗D免疫球蛋白(替代 IS)
??【編號】:NIBSC16/332

??【產品名稱】:抗D免疫球蛋白(替代 IS)

??【規格】:支

??【價格】:2600元

  抗D免疫球蛋白(替代 IS)

  編號:NIBSC16/332
  英文:Anti-D Immunoglobulin (Replacement IS)
  描述:
  1. INTENDED USE
Preparation 16/332, the 3rd International Standard for anti-D
immunoglobulin, is intended to be used as a standard in potency assays
of anti-D immunoglobulin products.
2. CAUTION
This preparation is not for administration to humans or animals in
the human food chain.
The preparation contains material of human origin, and either the final
product or the source materials, from which it is derived, have been
tested and found negative for HBsAg, anti-HIV and HCV RNA. 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
EACH AMPOULE CONTAINS 297 INTERNATIONAL UNITS OF ANTI-D
IMMUNOGLOBULIN.
4. CONTENTS
Country of origin of biological material: UK.
Preparation 16/332 consists of anti-D immunoglobulin product
manufactured from USA plasma. Each ampoule contains the lyophilized
residue of 1 ml of 2% (w/v) IgG in 0.25M glycine, 0.4% NaCl, pH 6.5.
5. STORAGE
Store unopened ampoules at -20°C or below.
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
Reconstitute the ampoule contents with 1.0 ml distilled or deionised water
containing 0.02% sodium azide.
8. STABILITY
It is the policy of WHO not to assign an expiry date to its international
reference materials. They remain valid with the assigned potency and
status until withdrawn or amended.
Reference materials are held at NIBSC within assured, temperaturecontrolled
storage facilities. Reference Materials should be stored on
receipt as indicated on the label. For information specific to a particular
biological standard, contact NIBSC.
Accelerated degradation studies on 16/332 indicate that the lyophilised
material will be adequately stable at -20oC with respect to anti-D potency. Once reconstituted, diluted or aliquoted, users should
determine the stability of the material according to their own method of
preparation, storage and use. However, tests at NIBSC have shown that
reconstituted 16/332 is stable for at least 1 month at 4°C in a tightlylidded
tube in the presence of 0.02% (w/v) sodium azide.
NIBSC follows the policy of WHO with respect to its reference materials.
Users who have data supporting any deterioration in the characteristics of
any reference preparation are encouraged to contact NIBSC.
9. REFERENCES
Fox, B. , Sharp, G. , Atkinson, E. , Roberts, G. , Rigsby, P. and Studholme,
L. (2019), The third international standard for anti‐D immunoglobulin:
international collaborative study to evaluate candidate preparations. Vox
Sang. https://doi.org/10.1111/vox.12822
10. ACKNOWLEDGEMENTS
We thank the participants of the collaborative study to assign unitage
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