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Y0001555

Ciclesonide impurity B

European Pharmacopoeia (EP) Reference Standard

Synonym(s):

Desisobutyryl-ciclesonide, (2′R)-2′-Cyclohexyl-11b,21-dihydroxy-16bH-[1,3]dioxolo[4′,5′:16,17]pregna-1,4-diene-3,20-dione

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About This Item

Empirical Formula (Hill Notation):
C28H38O6
CAS Number:
161115-59-9
Molecular Weight:
470.60
UNSPSC Code:
41116107
NACRES:
NA.24

biological source

synthetic

grade

pharmaceutical primary standard

Agency

EP

API family

ciclesonide

form

powder

packaging

pkg of 10 mg

manufacturer/tradename

EDQM

storage condition

protect from light

solubility

water: <0.1 g/L

application(s)

pharmaceutical (small molecule)

format

neat

shipped in

ambient

storage temp.

2-8°C

InChI

1S/C28H38O6/c1-26-11-10-18(30)12-17(26)8-9-19-20-13-23-28(22(32)15-29,27(20,2)14-21(31)24(19)26)34-25(33-23)16-6-4-3-5-7-16/h10-12,16,19-21,23-25,29,31H,3-9,13-15H2,1-2H3/t19-,20-,21-,23+,24+,25+,26-,27-,28+/m0/s1

InChI key

OXPLANUPKBHPMS-ZXBNPROVSA-N

Related Categories

General description

Ciclesonide impurity B is an impurity of ciclesonide, a new-generation, non-halogenated glucocorticoid.
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

Ciclesonide impurity B is used as an EP reference standard to quantify the analyte in pharmaceutical formulations by liquid chromatography (LC) technique.

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.

Regulatory Information

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New Drugs for Asthma, Allergy and COPD, 42, 42-54 (2001)
Ciclesonide
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 43, 2206-2207 (2017)
Rethinking Cleaning Validation for API Manufacturing
Zhang C, et al.
Pharmaceutical Technology, 42, 42-54 (2018)
Pharmacokinetics of [14 C] ciclesonide after oral and intravenous administration to healthy subjects
Nave R, et al.
Clinical Pharmacokinetics, 43, 479-486 (2004)

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