Y0001556
Ciclesonide impurity C
European Pharmacopoeia (EP) Reference Standard
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About This Item
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
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.
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 EP reference standard to quantify the analyte in pharmaceutical formulations using 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.
WGK
WGK 3
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
Regulatory Information
监管及禁止进口产品
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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
Ciclesonide
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 10.3 (2017)
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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