白介素17（人類rDNA衍生）（WHO參考試劑）

??【編號(hào)】：NIBSC01/420

??【名稱】：白介素17（人類rDNA衍生）（WHO參考試劑）

??【規(guī)格】：1個(gè)

??【價(jià)格】：2600元

　　白介素17（人類rDNA衍生）（WHO參考試劑）

　　編號(hào)：NIBSC01/420

　　英文：Interleukin-17 (Human rDNA derived)(WHO Reference Reagent)

　　標(biāo)準(zhǔn)類型：國際參考試劑

　　規(guī)格：1個(gè)

　　描述：1. INTENDED USE

This standard is the primary biological standard for Interleukin-17 (IL-17).

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

In a limited collaborative study, the preparation coded 01/420 was found

to possess IL-17 activity comparable to in-house standards, based on its

ability to stimulate release of IL-6 from human dermal fibroblasts or a

fibroblast cell line. The preparation is therefore established as the WHO

Reference Reagent for IL-17 for bioassay, with an assigned potency of

10,000 Units per ampoule. It should be noted that this assigned potency

is arbitrary, and does not reflect any pre-existing units for IL-17 activity,

and it does not establish continuity with any pre-existing in-house

standards. Users of the material should also note that the preparation

01/420 may be suitable to serve as a standard for the bioassay of IL-17

using assay methods based on other biological activities of IL-17, but

such applications have not been demonstrated for 01/420, and would

require appropriate validation. Users who have data supporting the use of

this preparation in another biological assay are encouraged to contact

NIBSC.

The preparation 01/420 was also shown to possess immunoactivity

comparable to in-house IL-17 standards, in a limited number of in-house

immunoassay systems. Whilst 01/420 is not formally established as an

immunoassay standard, it may be suitable as an immunoassay standard,

subject to appropriate validation. Users should note particularly that the

immunological stability of this preparation, stability after freezing and

thawing of the reconstituted ampoule contents has not been

demonstrated for all immunoassay systems, and such studies should be

undertaken by the user as part of such immunoassay application

validation.

4. CONTENTS

Country of origin of biological material: United Kingdom.

Each ampoule contains the residue after freeze-drying of 1.0 ml of a

solution comprising:

IL-17 approximately 1 microgram

9.0 mg sodium chloride

1.0 mg trehalose

2.0 mg human serum albumin

The IL-17A protein was expressed in E.coli

5. STORAGE

For economy of use, it is recommended that the solution be sub divided

into several small aliquots and stored at -40ºC or below. Avoid repeated

freezing/thawing. Unopened ampoules should be stored at –20ºC.

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

Dissolve the total contents of the ampoule in 1.0 ml of sterile distilled water.

This solution will contain IL-17 at a concentration of 10,000 Units/ml. Use

carrier protein where extensive dilution is required.

8. STABILITY

Reference materials are held at NIBSC within assured, temperaturecontrolled

storage facilities and they should be stored on receipt as

indicated on the label. It is the policy of WHO not to assign an expiry date

to their international reference materials. Accelerated degradation studies

have indicated that this material is suitably stable, when stored at -20ºC

or below, for the assigned values to remain valid until the material is

withdrawn or replaced. These studies have also shown that the material

is suitably stable for shipment at ambient temperature without any effect

on the assigned values. Once reconstituted, diluted or aliquoted, users

should determine the stability of the material according to their own

method of preparation, storage and use. Users who have data

supporting any deterioration in the characteristics of any reference

preparation are encouraged to contact NIBSC.

9. REFERENCES

The standard was produced under WHO guidelines cited in the WHO

Technical Reports Series, No.927, 2005

For details of the collaborative study report, please refer to WHO document

reference WHO/BS/06.2039

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