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Y0001554

Ciclesonide containing impurity A

European Pharmacopoeia (EP) Reference Standard

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About This Item

Código UNSPSC:
41116107
NACRES:
NA.24

origen biológico

synthetic

grado

pharmaceutical primary standard

Agency

EP

familia API

ciclesonide

envase

pkg of 15 mg

fabricante / nombre comercial

EDQM

condiciones de almacenamiento

protect from light

color

white

bp

665.0 °C/1.333 hPa (1229.0°F)

mp

209-211 °C (408—412°F)

solubilidad

water: <0.1 g/L
acetone: soluble
ethanol: soluble

densidad

1.23 g/cm3 at 20 °C (1.333 hPa)

aplicaciones

pharmaceutical (small molecule)

formato

neat

Condiciones de envío

ambient

temp. de almacenamiento

2-8°C

Descripción general

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.

Aplicación

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

Envase

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Otras notas

Sales restrictions may apply.

Producto relacionado

Código de clase de almacenamiento

11 - Combustible Solids

Clase de riesgo para el agua (WGK)

WGK 3

Punto de inflamabilidad (°F)

Not applicable

Punto de inflamabilidad (°C)

Not applicable


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Visite la Librería de documentos

Population pharmacokinetics and pharmacodynamics of ciclesonide
Rohatagi S, et al.
Journal of Clinical Pharmacology, 43(4), 365-378 (2003)
New Drugs for Asthma, Allergy and COPD, 42, 42-54 (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)
Ciclesonide
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 43, 2206-2207 (2017)

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