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Key Documents

Y0001536

Fludarabine for system suitability

European Pharmacopoeia (EP) Reference Standard

Synonym(s):

Fludarabine phosphate, 2-Fluoro-9-(5-O-phosphono-β-D-arabinofuranosyl)-9H-purin-6-amine

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About This Item

Empirical Formula (Hill Notation):
C10H13FN5O7P
CAS Number:
75607-67-9
Molecular Weight:
365.21
UNSPSC Code:
41116107
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

fludarabine

manufacturer/tradename

EDQM

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

InChI

1S/C10H13FN5O7P/c11-10-14-7(12)4-8(15-10)16(2-13-4)9-6(18)5(17)3(23-9)1-22-24(19,20)21/h2-3,5-6,9,17-18H,1H2,(H2,12,14,15)(H2,19,20,21)

InChI key

GIUYCYHIANZCFB-UHFFFAOYSA-N

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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

Fludarabine for system suitability 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.

Pictograms

Health hazard
GHS08

Signal Word

Warning

Hazard Statements

H341 - H361d

Hazard Classifications

Muta. 2 - Repr. 2

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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Lot/Batch Number

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W Plunkett et al.
Seminars in oncology, 17(5 Suppl 8), 3-17 (1990-10-01)
Fludara I.V. (fludarabine phosphate) (9-beta-D-arabinosyl-2-fluoroadenine, F-ara-A) is an adenine nucleoside analogue resistant to adenosine deaminase that shows promising therapeutic activity in the clinical treatment of lymphocytic hematologic malignancies. F-ara-A is transported into cells, where it is converted to its 5'-triphosphate
H M Kantarjian et al.
Seminars in oncology, 17(5 Suppl 8), 66-70 (1990-10-01)
The promising results obtained with Fludara I.V. (fludarabine phosphate) treatment in the common indolent B-cell neoplasms have led to their further evaluation in other unusual B-cell malignancies, in Hodgkin's disease, and in T-cell diseases. A significant response rate has been
B D Cheson
Seminars in oncology, 17(5 Suppl 8), 71-78 (1990-10-01)
Fludara I.V. (fludarabine phosphate) is a purine analogue with a high level of activity in a variety of indolent lymphoproliferative malignancies, including chronic lymphocytic leukemia (CLL), low-grade non-Hodgkin's lymphomas (NHL), cutaneous T-cell lymphoma, macroglobulinemia, and hairy-cell leukemia. The high response
J L Binet
Nouvelle revue francaise d'hematologie, 35(1), 5-7 (1993-02-01)
The review of Phase II trials in patients treated by Fludarabine phosphate (Fludara I.V) has been demonstrated to have unequivocal benefit for some patients with Chronic Lymphocytic Leukemia (CLL) non Hodgkin lymphoma and macroglobulinemia. Comparison of Fludara I.V with other
Fludarabine phosphate in the treatment of chronic lymphocytic leukemia: biology, clinical impact, and future directions.
L E Robertson et al.
Cancer treatment and research, 64, 105-119 (1993-01-01)
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