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status until withdrawn or amended.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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