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Key Documents

Y0001556

Ciclesonide impurity C

European Pharmacopoeia (EP) Reference Standard

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About This Item

分類程式碼代碼:
41116107
NACRES:
NA.24

生物源

synthetic

等級

pharmaceutical primary standard

agency

EP

API 家族

ciclesonide

形狀

powder

包裝

pkg of 10 mg

製造商/商標名

EDQM

儲存條件

protect from light

溶解度

water: <0.1 g/L

應用

pharmaceutical (small molecule)

格式

neat

運輸包裝

ambient

儲存溫度

2-8°C

一般說明

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.

應用

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

包裝

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

其他說明

Sales restrictions may apply.

儲存類別代碼

11 - Combustible Solids

水污染物質分類(WGK)

WGK 3

閃點(°F)

Not applicable

閃點(°C)

Not applicable


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分析證明 (COA)

Lot/Batch Number

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存取文件庫

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
Rethinking Cleaning Validation for API Manufacturing
Zhang C, et al.
Pharmaceutical Technology, 42, 42-54 (2018)

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