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Merck
CN

Y0001553

Ciclesonide

European Pharmacopoeia (EP) Reference Standard

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经验公式（希尔记法）:
C32H44O7
化学文摘社编号:
126544-47-6
分子量:
540.69
UNSPSC Code:
41116107
NACRES:
NA.24
MDL number:
MFCD00866004

主要文件

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产品名称

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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相关类别

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.

存储类别

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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New Drugs for Asthma, Allergy and COPD, 42, 42-54 (2001)
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)
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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