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阿苯達唑雜質混合物（Albendazole impurity mixture ）

??【編號】：EY0001959

??【產品名稱】：阿苯達唑雜質混合物（Albendazole impurity mixture ）

??【規格】：0.003 mg

??【用途】：

　　Identification

　　Catalogue code: Y0001959 Unit Quantity: ca 0.003 mg

　　2. Scientific Information

　　2.1 Intended use

　　Reference Standard for laboratory tests as prescribed in the European Pharmacopoeia only.

　　Established for use with the monograph(s): 1386.

　　2.2 Analytical information related to intended use

　　Chromatogram(s)/spectrum : See annex

　　2.3 Uncertainty of the assigned value, when applicable

　　The uncertainty of the assigned value is not stated since it is considered to be negligible in relation to

　　the defined limits of the method-specific assays for which the reference standard is used. Please also

　　refer to Ph. Eur. chapter 5.12.

　　2.4 Validity

　　Ph. Eur. RS are periodically tested to ensure their continuous fitness for purpose. For each valid Ph.

　　Eur. RS, a Batch Validity Statement at the time of use can be downloaded and printed from the EDQM

　　website (Reference Standards Database).

　　2.5 Instructions for use

　　The container should not be opened until required for use. Allow the closed container to equilibrate at

　　ambient temperature before opening to avoid uptake of moisture. Use “as is”. Do not dry/desiccate

　　before use. Ph. Eur. RS are for immediate use. Once the container has been opened, its entire content

　　must be used immediately. Any further storage and re-use are not warranted.

　　3. Storage conditions

　　In the original container at +5°C ± 3°C, protected from light. Re-instate promptly upon receipt.

　　4. Safety

　　For scientific research, development and analysis only. Handle in accordance with good occupational

　　hygiene, safety and laboratory practices and take precautions to avoid exposure. More information is

　　available at the EDQM website (Reference Standards Database): Safety Data Sheet for hazardous

　　chemicals and Safety Data Statement for other materials.

　　5. Shipping conditions

　　Each Ph. Eur. RS is shipped under conditions that preserve its suitability for use and comply with the

　　relevant regulations. For more details see EDQM website (Reference Standards Database).

　　6. Warranties, Liabilities and responsibility

　　- Safety

　　In the event of any safety concerns, please read carefully the safety data sheets or safety data statements

　　available for each product. It is for Purchasers to determine independently the risks associated with the items and

　　to take appropriate safety measures, including the provision of appropriate information, equipment and training

　　of those persons coming into contact with the item.

　　- Warranties

　　Except for the use of Reference Standards in tests and assays carried out in accordance with the official methods

　　of the European Pharmacopoeia and by professionals with the necessary technical skills and at their own

　　discretion and risk, the EDQM makes no representation, contractual statement, or expression of opinion

　　concerning the quality or safety of any item supplied, the presence of any defect in it, or its fitness for any

　　particular purpose except that as described above.

　　The EDQM does not guarantee that the items will meet the Purchaser’s specific expectations. The EDQM only

　　guarantees that the items (i) were fit for use according to EDQM’s intended use of the product ;(ii) were fit for

　　use at the moment that they were handed over to the carrier being responsible for the delivery of the items to

　　the Purchaser with such accessories including packaging, delivery instructions or other instructions for the item’s

　　delivery and reception as the Purchaser may expect to receive; and (iii) possess qualities and performance

　　capabilities which are normal in goods of the same type and which the Purchaser may expect given the nature of

　　the goods and the information provided on the EDQM’s website and (iv) the carrier and the Purchaser received

　　clear and accurate instructions for the item’s delivery and reception. No other guarantees, whether explicitly or

　　implied, are given by the EDQM. The EDQM does not guarantee that the purchase or use of the items will not

　　infringe any intellectual property rights, in particular patents.

　　- Limitation of Liability

　　In no event shall the EDQM be liable for any damages due to the use of items, included, but not limited to loss

　　of business, loss of profit, loss of use, loss of opportunity, costs of procurement of substitute goods, services or

　　systems or for any indirect, special, incidental, punitive or consequential damages, however caused and, whether

　　in contract, tort or under any other theory of liability, whether or not the Purchaser has been advised of the

　　possibility of such damages or costs.

　　Any liability of the EDQM for injury, loss or damage arising from the supply or use of any such item is in any

　　event hereby excluded to the fullest extent permitted internationally accepted commercial standards; in

　　particular, no liability is accepted for loss of profits or indirect or consequential loss.

　　7. Arbitration & Applicable Law

　　The aim of the EDQM is to settle any disputes amicably in the framework of its Terms and Conditions.

　　In accordance with the provisions of article 21 of the General Agreement on the Privileges and

　　Immunities of the Council of Europe, all disputes between the EDQM and the Purchaser as regards the

　　application of these General Terms shall be submitted, if a mutual agreement cannot be reached

　　between the parties, to arbitration as laid down in Order No. 481 of the Secretary General, approved

　　by the Committee of Ministers.

　　This transaction shall be governed by the Council of Europe’s relevant regulatory framework,

　　complemented, where necessary, by French national substantive law.

　　8. Citation

　　Users shall ensure that any reference made to an EDQM Reference Standard in any publication,

　　presentation or public document (ex. scientific articles, data sheets for kits) bears the exact name,

　　and catalogue code of the Reference Standard and the exact name and address of EDQM as given on

　　the first page of this information leaflet.

　　9. Adoption

　　The suitability for intended use has been officially adopted by the European Pharmacopoeia

　　Commission.

　　10. Signature

　　This document is electronically signed by:

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