Human rabies immunoglobulin BRP，H1100000，EP，EDQM标准物质证书电子版

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HUMAN RABIES IMMUNOGLOBULIN BRP batch 1

Human rabies immunoglobulin batch 1 is intended for use in the assay of human rabies immunoglobulin according to the Ph. Eur. monograph human rabies immunoglobulin (0723). The BRP consists of freeze-dried human rabies immunoglobulin presented in vials with a declared content of

91 IU/vial

STORAGE

Keep vials unopened at – 20 °C. Do not store at lower temperatures to avoid deterioration of the rubber stoppers.

USE

• Allow the vial and content to reach room temperature.

• Tap vial gently to collect material at the bottom.

• Using an appropriate syringe reconstitute the reference preparation by injecting a suitable volume of water for injections R (for example 1.0 ml). Carefully mix and stir very gently, avoiding spuming. Total dissolution of the freeze-dried material may only be obtained after 1h to 1.5h of such treatment at room temperature; check by visual inspection that complete dissolution has been achieved prior to use. Dilute where appropriate so as to obtain the required concentration.

• Use as soon as possible after reconstitution. Do not freeze or store for subsequent use.

Human rabies immunoglobulin BRP.pdf