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H0920500

Human coagulation factor IX concentrate BRP

European Pharmacopoeia (EP) Reference Standard

Synonym(s):

Factor IX human, Christmas factor, Plasma thromboplastin component

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About This Item

CAS Number:
MDL number:
UNSPSC Code:
12352200

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

−20°C

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General description

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.

Application

Human coagulation factor IX concentrate BRP EP Reference standard, intended for use in laboratory tests only as specifically prescribed in the European Pharmacopoeia.

Packaging

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

Other Notes

Sales restrictions may apply.

Regulatory Information

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Tengguo Li et al.
American journal of hematology, 89(4), 375-379 (2014-01-01)
Hemophilia B (HB) is a disorder resulting from genetic mutations in the Factor 9 gene (F9). Genotyping of HB patients is important for genetic counseling and patient management. Here we report a study of mutations identified in a large sample
GlycoPEGylated factor IX: a new step forward.
Maria Elisa Mancuso
Blood, 124(26), 3836-3837 (2014-12-20)
Peter W Collins et al.
Blood, 124(26), 3880-3886 (2014-09-28)
This multinational, randomized, single-blind trial investigated the safety and efficacy of nonacog beta pegol, a recombinant glycoPEGylated factor IX (FIX) with extended half-life, in 74 previously treated patients with hemophilia B (FIX activity ≤2 IU/dL). Patients received prophylaxis for 52
Jerry Powell et al.
British journal of haematology, 168(1), 113-123 (2014-09-12)
In the phase 3 B-LONG [Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Subjects with Haemophilia B] study, rFIXFc dosed every 1-2 weeks was safe and efficacious in previously treated subjects with haemophilia B. To date, there are no evaluations of
Jerry S Powell et al.
British journal of haematology, 168(1), 124-134 (2014-09-12)
In the phase 3 B-LONG (Recombinant Factor IX Fc Fusion Protein [rFIXFc] in Subjects With Haemophilia B) study, rFIXFc demonstrated a prolonged half-life compared with recombinant factor IX (rFIX), and safety and efficacy for prophylaxis and treatment of bleeding in

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