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Key Documents

Y0001598

Dutasteride

European Pharmacopoeia (EP) Reference Standard

Synonyme(s) :

(5α,17β)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-1-ene-17-carboxamide

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About This Item

Formule empirique (notation de Hill):
C27H30F6N2O2
Numéro CAS:
Poids moléculaire :
528.53
Numéro MDL:
Code UNSPSC :
41116107
ID de substance PubChem :
Nomenclature NACRES :
NA.24

Qualité

pharmaceutical primary standard

Famille d'API

dutasteride

Fabricant/nom de marque

EDQM

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-8°C

Chaîne SMILES 

O=C1C=C[C@@]2(C)[C@](CC[C@]3([H])[C@]2([H])CC[C@@]4(C)[C@@]3([H])CC[C@@H]4C(NC5=CC(C(F)(F)F)=CC=C5C(F)(F)F)=O)([H])N1

InChI

1S/C27H30F6N2O2/c1-24-11-9-17-15(4-8-21-25(17,2)12-10-22(36)35-21)16(24)6-7-19(24)23(37)34-20-13-14(26(28,29)30)3-5-18(20)27(31,32)33/h3,5,10,12-13,15-17,19,21H,4,6-9,11H2,1-2H3,(H,34,37)(H,35,36)/t15-,16-,17-,19+,21+,24-,25+/m0/s1

Clé InChI

JWJOTENAMICLJG-QWBYCMEYSA-N

Informations sur le gène

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Description générale

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

Dutasteride EP Reference standard, intended for use in laboratory tests only as specifically prescribed in the European Pharmacopoeia.

Conditionnement

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

Autres remarques

Sales restrictions may apply.

Pictogrammes

Health hazard

Mention d'avertissement

Danger

Mentions de danger

Conseils de prudence

Classification des risques

Carc. 2 - Repr. 1B

Code de la classe de stockage

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

Lot/Batch Number

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Laurence Klotz et al.
Canadian Urological Association journal = Journal de l'Association des urologues du Canada, 8(11-12), E789-E794 (2014-12-09)
We studied the effect of dutasteride on the length of the off-treatment period in prostate cancer patients on intermittent androgen deprivation (IAD) therapy. We conducted a randomized, placebo-controlled Phase II trial in men with localized prostate cancer and a rising
Elahe A Mostaghel et al.
PloS one, 9(10), e111545-e111545 (2014-10-31)
Factors influencing differential responses of prostate tumors to androgen receptor (AR) axis-directed therapeutics are poorly understood, and predictors of treatment efficacy are needed. We hypothesized that the efficacy of inhibiting DHT ligand synthesis would associate with intra-tumoral androgen ratios indicative
Gerald L Andriole et al.
Urology, 84(2), 393-399 (2014-06-12)
To explore explanations for the numerical imbalance of biopsy-detected Gleason 8-10 prostate cancers (PCa) diagnosed in years 3-4 in the dutasteride and placebo groups of the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study. REDUCE was a 4-year, randomized
Adriana C Vidal et al.
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 23(12), 2936-2942 (2014-09-30)
Studies suggest that obesity is associated with lower risk of prostate cancer but more aggressive cancers. As obesity lowers PSA levels, these observations may be influenced by detection bias. We examined the association between obesity and risk of low- and
Matthias Oelke et al.
World journal of urology, 32(5), 1141-1147 (2014-06-07)
To assess the impact of dutasteride compared with placebo on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia, using pooled data from dutasteride phase III studies. Nocturia was assessed using Question 7 of the International

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