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CN

Y0001553

Ciclesonide

European Pharmacopoeia (EP) Reference Standard

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About This Item

Empirical Formula (Hill Notation):
C32H44O7
CAS Number:
126544-47-6
Molecular Weight:
540.69
UNSPSC Code:
41116107
NACRES:
NA.24
MDL number:
MFCD00866004

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Product Name

Ciclesonide, European Pharmacopoeia (EP) Reference Standard

InChI

1S/C32H44O7/c1-18(2)28(36)37-17-25(35)32-26(38-29(39-32)19-8-6-5-7-9-19)15-23-22-11-10-20-14-21(33)12-13-30(20,3)27(22)24(34)16-31(23,32)4/h12-14,18-19,22-24,26-27,29,34H,5-11,15-17H2,1-4H3/t22-,23-,24-,26+,27+,29+,30-,31-,32+/m0/s1

SMILES string

C[C@@]12C(CC[C@]3([H])[C@]2([H])[C@@H](O)C[C@@]4(C)[C@@]3([H])C[C@]5([H])[C@]4(O[C@@](C6CCCCC6)([H])O5)C(COC(C(C)C)=O)=O)=CC(C=C1)=O

InChI key

LUKZNWIVRBCLON-GXOBDPJESA-N

biological source

synthetic

grade

pharmaceutical primary standard

agency

EP

API family

ciclesonide

packaging

pkg of 150 mg

manufacturer/tradename

EDQM

storage condition

protect from light

color

white

bp

665.0 °C/1.333 hPa (1229.0°F)

mp

209-211 °C (408—412°F)

solubility

water: <0.1 g/L
acetone: soluble
ethanol: soluble

density

1.23 g/cm3 at 20 °C (1.333 hPa)

application(s)

pharmaceutical (small molecule)

format

neat

shipped in

ambient

storage temp.

2-8°C

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Application

This European Pharmacopoeia reference standard is intended for use only as specifically prescribed in the European Pharmacopoeia.

General description

Ciclesonide is a new-generation, non-halogenated glucocorticoid. It is a prodrug that releases an active primary metabolite, ciclesonide−active principle (CIC-AP), on enzymatic cleavage.
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.

Other Notes

Sales restrictions may apply.

Packaging

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

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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Forced degradation study to develop and validate stability-indicating RP-LC method for the determination of ciclesonide in bulk drug and metered dose inhalers
Elkady EF and Fouad MA
Talanta, 87, 222-229 (2011)
New Drugs for Asthma, Allergy and COPD, 42, 42-54 (2001)
RP-HPLC method for simultaneous estimation of formoterol fumarate, tiotropium bromide and ciclesonide in pharmaceutical metered dose inhalers
Pulla RP, et al.
Asian Journal of Research in Chemistry, 4(4), 585-590 (2011)
Sensitive LC method for simultaneous determination of ciclesonide and formoterol fumarate in dry powder inhaler
Patil AT, et al.
Journal of Liquid Chromatography and Related Technologies, 34(15), 1568-1577 (2011)
Population pharmacokinetics and pharmacodynamics of ciclesonide
Rohatagi S, et al.
Journal of Clinical Pharmacology, 43(4), 365-378 (2003)
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