Y0001554

Ciclesonide containing impurity A

European Pharmacopoeia (EP) Reference Standard

NACRES:
NA.24
Pricing and availability is not currently available.

biological source

synthetic

grade

pharmaceutical primary standard

Agency/Method

EP

form

neat

CofA

certificate is enclosed in each package

packaging

pkg of 15 mg

mfr. no.

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)

Featured Industry

Pharmaceutical (small molecule)

format

neat

shipped in

ambient

storage temp.

2-8°C

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.

Application

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

Packaging

Unit quantity: 15 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
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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