Docstoc

INTERFERON ALPHA Human leukocyte derived

Document Sample
INTERFERON ALPHA Human leukocyte derived Powered By Docstoc
					                WHO International Standard                                   7. USE OF MATERIAL
       INTERFERON ALPHA n3, (Human, leukocyte-derived)                       No attempt should be made to weigh out any portion of the freeze-dried
                    NIBSC code: 95/574                                       material prior to reconstitution
                     Instructions for use                                    No attempt should be made to weigh out any portion of the freeze-dried
               (Version 5.0, Dated 14/02/2008)                               material. Dissolve the total contents of the ampoule in 0.5ml of sterile distilled
                                                                             water and transfer to a sterile container. Rinse the ampoule with about 0.4ml
                                                                             of sterile distilled water and add to the first solution. Make up the total volume
1. INTENDED USE                                                              to 1.0ml with sterile distilled water. The final solution will contain IFN alpha
This material is the 1st WHO International Standard for human interferon     n3 at a concentration of 60000 International Units per ml. Use carrier protein
alpha n3 of leukocyte origin. This material is intended for use as the       where dilution is required. It is recommended that initial dilutions, i.e. 1:10,
primary biological standard in bioassays for human interferon alpha n3. It   1:100, are either made in cell culture medium containing - 5%v/v –10%v/v
is recommended for calibration of interferon alpha n3 preparations only.     calf serum or in phosphate-buffered saline, pH 7.0-7.4, containing 0.3%v/v
These are derived from leukocyte-derived human interferon alpha by           bovine casein to prevent adsorption of IFN to container surfaces.
purification using NK2 monoclonal antibody affinity chromatography.
                                                                             8. STABILITY
2. CAUTION                                                                   Reference materials are held at NIBSC within assured, temperature-
This preparation is not for administration to humans.                        controlled storage facilities. Reference Materials should be stored on
                                                                             receipt as indicated on the label.
The preparation contains material of human origin, and either the final
product or the source materials, from which it is derived, have been         NIBSC follows the policy of WHO with respect to its reference materials.
tested and found negative for HBsAg, anti-HIV and HCV RNA. As with
all materials of biological origin, this preparation should be regarded as   9. REFERENCES
potentially hazardous to health. It should be used and discarded             Meager, A, Gaines Das, R, Zoon K. and Mire-Sluis, A. (2001) Establishment
according to your own laboratory's safety procedures. Such safety            of new and replacement World Health Organisation International Biological
procedures should include the wearing of protective gloves and               Standards for human interferon alpha and omega. Journal of Immunological
avoiding the generation of aerosols. Care should be exercised in             Methods, 257, 17-33.
opening ampoules or vials, to avoid cuts.
                                                                             This standard was produced under WHO guidelines as cited in the WHO
3. UNITAGE                                                                   Technical Reports series 800, 1990, Annex 4.
60, 000 International Units per ampoule
                                                                             10. ACKNOWLEDGEMENTS
4. CONTENTS                                                                  N/A
Country of origin of biological material: United Kingdom.
Each ampoule contains a freeze-dried residue comprising, under an            11. FURTHER INFORMATION
atmosphere of nitrogen:                                                      Further information can be obtained as follows;
Interferon alpha n3, approximately 250 ng                                    This material:
6-salt phosphate buffered saline pH 7.0                                      enquiries@nibsc.hpa.org.uk
6.0 mg human serum albumin.                                                  WHO Biological Standards:
                                                                             Http://www.who.int/biologicals/en/
The human interferon alpha n3 was derived from human leukocytes.             JCTLM Higher order reference materials:
                                                                             Http://www.bipm.org/en/committees/jc/jctlm/
5. STORAGE                                                                   Derivation of International Units:
For economy of use, it is recommended that the final solution be sub-        http://www.who.int/biologicals/reference_preparations/en/
divided into several small aliquots and stored at -40ºC or below. Avoid      Ordering standards from NIBSC:
repeated thawing/freezing. Unopened ampoules should be stored at –           Http://www.nibsc.ac.uk/products/ordering_information/frequently_asked_
20oC.                                                                        questions.aspx
                                                                             NIBSC Terms & Conditions:
6. DIRECTIONS FOR OPENING                                                    Http://www.nibsc.ac.uk/terms_and_conditions.aspx
DIN ampoules have an „easy-open‟ coloured stress point, where the
narrow ampoule stem joins the wider ampoule body.
Tap the ampoule gently to collect the material at the bottom (labeled)       12. CUSTOMER FEEDBACK
end. Ensure that the disposable ampoule safety breaker provided is           Customers are encouraged to provide feedback on the suitability or use
pushed down on the stem of the ampoule and against the shoulder of           of the material provided or other aspects of our service. Please send any
the ampoule body. Hold the body of the ampoule in one hand and the           comments to enquiries@nibsc.hpa.org.uk
disposable ampoule breaker covering the ampoule stem between the
thumb and first finger of the other hand. Apply a bending force to open      13. CITATION
the ampoule at the coloured stress point, primarily using the hand           In all publications, including data sheets, in which this material is
holding the plastic collar.                                                  referenced, it is important that the preparation's title, its status, the NIBSC
Care should be taken to avoid cuts and projectile glass fragments that       code number, and the name and address of NIBSC are cited and cited
might enter the eyes, for example, by the use of suitable gloves and an      correctly.
eye shield. Take care that no material is lost from the ampoule and no
glass falls into the ampoule. Within the ampoule is dry nitrogen gas at      14.   MATERIAL SAFETY SHEET
slightly less than atmospheric pressure. A new disposable ampoule
breaker is provided with each DIN ampoule.




                                                                                                                                                Page 1 of 2
                                                                                the handling charge provided that performance of either one of the above
                 Physical and Chemical properties                               options shall constitute an entire discharge of the Institute‟s liability under
Physical              Corrosive:          No                                    this Condition.
appearance:
Freeze-dried white                                                              16. INFORMATION FOR CUSTOMS USE ONLY
powder                                                                           Country of origin for customs purposes*: United Kingdom
Stable:               Oxidising:          No                                     * Defined as the country where the goods have been produced and/or
          Yes                                                                    sufficiently processed to be classed as originating from the country of
Hygroscopic:          Irritant:           No                                     supply, for example a change of state such as freeze-drying.
          Yes                                                                    Net weight: 1g
Flammable:            Handling:           See caution, Section 2                 Toxicity Statement: Toxicity not assessed
          No                                                                     Veterinary certificate or other statement if applicable.
Other (specify):   Contains material of human origin                             Attached: No
                        Toxicological properties
Effects of inhalation:          Not established, avoid inhalation
Effects of ingestion: Not established, avoid ingestion
Effects of skin absorption:     Not established, avoid contact with skin
                           Suggested First Aid
Inhalation:        Seek medical advice
Ingestion: Seek medical advice
Contact with eyes: Wash with copious amounts of water. Seek
medical advice
Contact with skin: Wash thoroughly with water.
              Action on Spillage and Method of Disposal
Spillage of ampoule contents should be taken up with absorbent
material wetted with an appropriate disinfectant. Rinse area with an
appropriate disinfectant followed by water.
Absorbent materials used to treat spillage should be treated as
biological waste.

15. LIABILITY AND LOSS
Information provided by the Institute is given after the exercise of all
reasonable care and skill in its compilation, preparation and issue, but
it is provided without liability to the Recipient in its application and use.
It is the responsibility of the Recipient to determine the appropriateness
of the standards or reference materials supplied by the Institute to the
Recipient (“the Goods”) for the proposed application and ensure that it
has the necessary technical skills to determine that they are
appropriate. Results obtained from the Goods are likely to be
dependant on conditions of use by the Recipient and the variability of
materials beyond the control of the Institute.
All warranties are excluded to the fullest extent permitted by law,
including without limitation that the Goods are free from infectious
agents or that the supply of Goods will not infringe any rights of any
third party.
The Institute shall not be liable to the Recipient for any economic loss
whether direct or indirect, which arise in connection with this
agreement.
The total liability of the Institute in connection with this agreement,
whether for negligence or breach of contract or otherwise, shall in no
event exceed 120% of any price paid or payable by the Recipient for
the supply of the Goods.
If any of the Goods supplied by the Institute should prove not to meet
their specification when stored and used correctly (and provided that
the Recipient has returned the Goods to the Institute together with
written notification of such alleged defect within seven days of the time
when the Recipient discovers or ought to have discovered the defect),
the Institute shall either replace the Goods or, at its sole option, refund




                                                                                                                                                Page 2 of 2

				
DOCUMENT INFO