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Dissolution Performance Verification Standard - Prednisone (30 tablets)

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): DPVS-Prednisone
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• Agency: certified by the USP
• API family: prednisone
• form: tablet
• manufacturer/tradename: USP
• concentration: 10 mg/tablet (nominal prednisone content per tablet)
• application(s): pharmaceutical
• format: mixture
• storage temp.: room temp

Description

General description

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.

Application

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.

Components

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)

Analysis Note

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.

Other Notes

Sales restrictions may apply.

Safety Information

• Pictograms: GHS08
• Signal Word: Warning
• Hazard Statements: H373
• Precautionary Statements: P260 - P314 - P501
• Hazard Classifications: STOT RE 2 Inhalation
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3