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Y0001536

Fludarabine for system suitability

European Pharmacopoeia (EP) Reference Standard

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

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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G Rodriguez
Investigational new drugs, 12(2), 75-92 (1994-01-01)
Fludarabine phosphate is a purine antimetabolite approved for use in the management of patients with chronic lymphocytic leukemia. Fludarabine works primarily by inhibiting DNA synthesis. The compound also possesses lymphocytotoxic activity with preferential activity toward T-lymphocytes. Initial preclinical studies demonstrated
D D Von Hoff
Seminars in oncology, 17(5 Suppl 8), 33-38 (1990-10-01)
There have been six different phase I trials of Fludara I.V. (fludarabine phosphate) in patients with solid tumors and three different phase I trials of Fludara I.V. in patients with acute leukemia. In addition, one trial of the agent given
M J Keating
Seminars in oncology, 17(5 Suppl 8), 49-62 (1990-10-01)
Fludara I.V. (fludarabine phosphate) is a purine analogue that has been synthesized and found to have activity in lymphoid neoplasms in phase I and II studies. Fludara I.V. has been used extensively in the management of chronic lymphocytic leukemia in
Fludarabine phosphate: a new active agent in hematologic malignancies.
M J Keating et al.
Seminars in hematology, 31(1), 28-39 (1994-01-01)
H G Chun et al.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 9(1), 175-188 (1991-01-01)
Fludarabine phosphate is the 2-fluoro, 5'-monophosphate derivative of vidarabine (ara-A) with the advantages of resistance to deamination by adenosine deaminase (ADA) and improved solubility. The mechanism of cytotoxic action of the compound appears to involve metabolic conversion to the active
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