产品名称
Ciclesonide containing impurity A, European Pharmacopoeia (EP) Reference Standard
biological source
synthetic
grade
pharmaceutical primary standard
agency
EP
API family
ciclesonide
packaging
pkg of 15 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
Application
Ciclesonide containing impurity A is used as an EP reference standard to quantify the analyte in pharmaceutical formulations by liquid chromatography (LC) technique.
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.
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
法规信息
涉药品监管产品
此项目有
New Drugs for Asthma, Allergy and COPD, 42, 42-54 (2001)
Population pharmacokinetics and pharmacodynamics of ciclesonide
Rohatagi S, et al.
Journal of Clinical Pharmacology, 43(4), 365-378 (2003)
Ciclesonide
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 43, 2206-2207 (2017)
Pharmacokinetics of [14 C] ciclesonide after oral and intravenous administration to healthy subjects
Nave R, et al.
Clinical Pharmacokinetics, 43, 479-486 (2004)
Rethinking Cleaning Validation for API Manufacturing
Zhang C, et al.
Pharmaceutical Technology, 42, 42-54 (2018)
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