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Merck
CN
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文件

安全信息

Y0001554

Ciclesonide containing impurity A

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

包装

pkg of 15 mg

制造商/商品名称

EDQM

储存条件

protect from light

颜色

white

bp

665.0 °C/1.333 hPa (1229.0°F)

mp

209-211 °C (408—412°F)

溶解性

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

密度

1.23 g/cm3 at 20 °C (1.333 hPa)

应用

pharmaceutical (small molecule)

格式

neat

运输

ambient

储存温度

2-8°C

一般描述

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.

应用

Ciclesonide containing impurity A is used as an EP reference standard to quantify the analyte in pharmaceutical formulations by 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

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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