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重要文件

Y0001969

依那西普

European Pharmacopoeia (EP) Reference Standard

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About This Item

CAS號碼:
分類程式碼代碼:
41116107
NACRES:
NA.24
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等級

pharmaceutical primary standard

API 家族

etanercept

製造商/商標名

EDQM

應用

pharmaceutical

形式

neat

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一般說明

Etanercept is one of the biologic disease-modifying anti-rheumatic drugs (DMARDs) used to treat rheumatoid arthritis (RA). It acts as a tumor necrosis factor (TNF) antagonist by binding with TNF cytokine or protein, thereby blocking its interaction with cell surface receptors. Thus, etanercept effectively relieves joint inflammation from RA and lowers the disease activity.[1][2][3][4][5][6]
This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the Issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

應用

This product is intended for laboratory tests as prescribed in the EP only. Established for use with the monograph(s): 2895.

包裝

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

其他說明

Sales restrictions may apply.

相關產品

儲存類別代碼

11 - Combustible Solids

水污染物質分類(WGK)

WGK 3

閃點(°F)

Not applicable

閃點(°C)

Not applicable


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分析證明 (COA)

Lot/Batch Number

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存取文件庫

Etanercept concentration in patients with rheumatoid arthritis and its potential influence on treatment decisions: a pilot study
Daien CI, et al.
The Journal of Rheumatology, 39(8), 1533-1538 (2012)
Development of a sensitive enzyme-linked immunosorbent assay for the measurement of biologically active etanercept in patients with ankylosing spondylitis
Wang L, et al.
Journal of Chromatography. B, Biomedical Applications, 1008, 219-224 (2016)
Etanercept
European Pharmacopoeia Commission and Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 4979-4983 (2021)
Characterization and application of a unique panel of monoclonal antibodies generated against etanercept
Detrez I, et al.
Journal of Immunology, 196(6), 2879-2884 (2016)
Etanercept: An overview
Goffe B and Cather JC
Journal of the American Academy of Dermatology, 49(2), 105-111 (2003)

Questions

1–2 of 2 Questions  
  1. Bonjour, j'ai reconstitué un aliquot d'étanercept dans l'eau. combien de temps puis je le garder à 4 degres ou est il preferable de le congeler?

    1 answer
    1. Recommendations against the long-term storage and use of this standard are listed in the associated Information Leaflet published by the European Pharmacopoeia. From the leaflet:

      "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. This substance has been freeze-dried and is known to be hygroscopic. Tap the container gently to collect the material at the bottom. Reconstitute the contents by injecting a suitable volume of the solvent. Mix gently to ensure complete dissolution. When necessary transfer the solution to an appropriate volumetric flask and dilute to the required concentration. 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."

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  2. What is the recommended method for reconstituting Etanercept (Y0001969), and how should the stock solutions be stored?

    1 answer
    1. Etanercept (Y0001969) is soluble in water. Once reconstituted, stock solutions should be aliquoted into tightly sealed vials and used within one month to ensure stability. It is important to avoid repeated freeze-thaw cycles to maintain the integrity of the solution.

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