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Y0001598

Dutasteride

European Pharmacopoeia (EP) Reference Standard

Synonym(s):

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

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About This Item

Empirical Formula (Hill Notation):
C27H30F6N2O2
CAS Number:
164656-23-9
Molecular Weight:
528.53
MDL number:
MFCD00937869
UNSPSC Code:
41116107
PubChem Substance ID:
329831503
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

dutasteride

manufacturer/tradename

EDQM

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

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

InChI key

JWJOTENAMICLJG-QWBYCMEYSA-N

Gene Information

human ... SRD5A1(6715) , SRD5A2(6716) , SRD5A3(79644)

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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

Dutasteride 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

Danger

Hazard Statements

H351,H360FD

Precautionary Statements

P201 - P308 + P313

Hazard Classifications

Carc. 2 - Repr. 1B

Storage Class Code

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

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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Certificates of Analysis (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
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
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
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