Y0001556

Ciclesonide impurity C

European Pharmacopoeia (EP) Reference Standard

NACRES:
NA.24

biological source

synthetic

grade

pharmaceutical primary standard

Agency/Method

EP

form

powder

packaging

pkg of 10 mg

manufacturer/tradename

EDQM

storage condition

protect from light

solubility

water: <0.1 g/L

Featured Industry

Pharmaceutical (small molecule)

format

neat

shipped in

ambient

storage temp.

2-8°C

General description

Ciclesonide impurity C is an impurity of ciclesonide, which is 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 C is used as a pharmaceutical primary standard to quantify the analyte in pharmaceutical formulations using liquid chromatography (LC) technique.

Packaging

Unit quantity: 10 mg. Subject to change. The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Caution

Other Notes

Sales restrictions may apply.

RIDADR

NONH for all modes of transport

WGK Germany

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis
Certificate of Origin
Ciclesonide
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 10.3 (2017)
Ruediger Nave et al.
Clinical pharmacokinetics, 43(7), 479-486 (2004-05-14)
Ciclesonide is a novel inhaled corticosteroid developed for the treatment of asthma. To investigate the extent of oral absorption and bioavailability of ciclesonide referenced to an intravenous infusion. This information provides an estimate for the contribution of the swallowed fraction...
New Drugs for Asthma, Allergy and COPD (2001)
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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