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催乳素,人类(第4届WHO国际标准)
  【编号】:NIBSC83/573

  【产品名称】:催乳素,人类(第4届WHO国际标准)

  【规格】:个

  【价格】:2400元

  催乳素,人类(第4届 WHO国际标准。)

  编号:NIBSC83/573
  英文:Prolactin, Human (4th WHO International Standard.)
  标准类型:国际标准品
  规格:1个
  描述:
1. INTENDED USE
The 3
rd International Standard (IS) for Prolactin, human, in ampoules
coded 84/500, has been widely used for the calibration of
immuoassays of Prolactin. Stocks of the 3rd IS are exhausted and the
WHO Expert Committee on Biological Standardization (ECBS) has
recognised (2015) the need for a replacement IS.
The 4th IS consists of a batch of ampoules, coded 83/573, which
contain purified prolactin of human, pituitary origin. The ampouled
preparation has been calibrated in an international collaborative study
(2016) in terms of the 3rd IS, 84/500. The 4th IS, coded 83/573, was
established at the 67th meeting of the ECBS in 2016. This material
replaces the 3rd IS which is discontinued.
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 67 MILLI INTERNATIONAL UNITS of human
prolactin.
4. CONTENTS
Country of origin of biological material: Sweden
Each ampoule of the material contains the residue, after freeze-drying,
of a solution which contained:-
Human prolactin approximately 3.2 µg
Human albumin 1.0 mg
Lactose 5.0 mg
Ammonium formate 0.63 mg
Nitrogen gas at slightly less than atmospheric pressure
5. STORAGE
Unopened ampoules should be stored at -20°C.
Please note: because of the inherent stability of lyophilized
material, NIBSC may ship these materials at ambient temperature.
6. DIRECTIONS FOR OPENING
Tap the ampoule gently to collect the material at the bottom (labelled)
end. Ensure ampoule is scored all round at the narrow part of the
neck, with a diamond or tungsten carbide tipped glass knife file or
other suitable implement before attempting to open. Place the
ampoule in the ampoule opener, positioning the score at position 'A';
shown in the diagram below. Surround the ampoule with cloth or
layers of tissue paper. Grip the ampoule and holder in the hand and
squeeze at point 'B'. The ampoule will snap open. Take care to avoid
cuts and projectile glass fragments that enter eyes. Take care that no
material is lost from the ampoule and that no glass falls into the
ampoule.Side view of ampoule opening device containing an ampoule positioned
ready to open. 'A' is the score mark and 'B' the point of applied pressure.
7. USE OF MATERIAL
No attempt should be made to weigh out any portion of the freeze-dried
material prior to reconstitution.
For practical purposes each ampoule contains the same quantity of
human prolactin. Tap the ampoule to collect material at the base of the
ampoule and dissolve the total contents in a known volume of a suitable
diluent. Addition of a carrier protein (e.g. 0.05 - 0.1% (w/v) bovine or
human serum albumin) is recommended. Ensure all the material in
ampoule is reconstituted by using the known volume of diluent to rinse all
inner surfaces of the ampoule, collecting all the rinses to prepare the
stock concentration. Unopened ampoules of the material should be
stored below 4oC. The ampoules do not contain bacteriostat and
solutions of the material should not be assumed to be sterile.
8. PREPARATION OF AMPOULES
Ampoules were prepared as described in the ECBS report
WHO/BS/86.15201
and in Schulster2
et al. (1989), using a quantity of
highly purified extract donated by KabiVitrum, Sweden through the good
offices of Dr L. Fryklund. Prolactin content in terms of the 3rd International
Standard for Prolactin, coded 84/500, was assigned by an international
collaborative study (2016) involving ten laboratories in seven countries.
There was good agreement between laboratories giving an assigned
immunoreactivity of 67 mIU/amp (GCV 8.1%; n=18). Using a panel of
human sera containing normal and high prolactin concentratrions (n=16),
the material was shown to be commutable. Full details of the
collaborative study can be found in the ECBS report,
WHO/BS/2016.22923
.
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