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重要文件

1222818

USP

Dissolution Performance Verification Standard - Prednisone (30 tablets)

United States Pharmacopeia (USP) Reference Standard

同義詞:

DPVS-Prednisone

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About This Item

分類程式碼代碼:
41116107
NACRES:
NA.24

等級

pharmaceutical primary standard

agency

certified by the USP

API 家族

prednisone

形狀

tablet

製造商/商標名

USP

濃度

10 mg/tablet (nominal prednisone content per tablet)

應用

pharmaceutical

形式

mixture

儲存溫度

room temp

一般說明

The USP Performance Verification Test (PVT) is an essential aspect of the General Chapter <711> Dissolution that assesses the comprehensive performance of Dissolution Apparatus 1 (basket) and Dissolution Apparatus 2 (paddle). DPVS - Prednisone Tablets is specially engineered by USP to use as a reference standard for PVT of apparatus used in dissolution testing for the following reasons:

  • High stability and ease of use
  • High sensitivity to operational and mechanical variables of instrument setup
  • Low sensitivity to media degassing
  • Low tablet-to-tablet variability
These features help enable you to identify any differences from the ideal dissolution instrument setup so you can have confidence in your dissolution testing results.

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, has 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

Dissolution Performance Verification Standard (DPVS) – Prednisone tablets USP reference standard is used for the comprehensive qualification of dissolution instruments using performance verification testing (PVT) to achieve reliable results that reflect the quality of the drug product.

成分

Each tablet contains: Dicalcium Phosphate Anhydrous (7757-93-9), Microcrystalline Cellulose (9004-34-6), Colloidal silicone dioxide (112945-52-5), Magnesium Stearate (557-04-0), Prednisone (53-03-2), Sodium Dodecyl Sulfate Fine (151-21-3), Sodium Starch Glycolate Type A (9063-38-1)

分析報告

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.

其他說明

Sales restrictions may apply.

象形圖

Health hazard

訊號詞

Warning

危險聲明

防範說明

危險分類

STOT RE 2 Inhalation

儲存類別代碼

11 - Combustible Solids

水污染物質分類(WGK)

WGK 3


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