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安全信息

Y0001556

Ciclesonide impurity C

European Pharmacopoeia (EP) Reference Standard

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UNSPSC代码:
41116107
NACRES:
NA.24

生物来源

synthetic

等级

pharmaceutical primary standard

Agency

EP

API类

ciclesonide

形式

powder

包装

pkg of 10 mg

制造商/商品名称

EDQM

储存条件

protect from light

溶解性

water: <0.1 g/L

应用

pharmaceutical (small molecule)

格式

neat

运输

ambient

储存温度

2-8°C

一般描述

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.

应用

Ciclesonide impurity C is used as a EP reference standard to quantify the analyte in pharmaceutical formulations using liquid chromatography (LC) technique.

包装

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

其他说明

Sales restrictions may apply.

WGK

WGK 3

闪点(°F)

Not applicable

闪点(°C)

Not applicable

法规信息

监管及禁止进口产品

分析证书(COA)

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访问文档库

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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