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USP

Dissolution Performance Verification Standard - Prednisone (30 tablets)

United States Pharmacopeia (USP) Reference Standard

Sinónimos:

DPVS-Prednisone

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About This Item

Código UNSPSC:
41116107
NACRES:
NA.24
En este momento no podemos mostrarle ni los precios ni la disponibilidad

grado

pharmaceutical primary standard

Agency

certified by the USP

familia API

prednisone

Formulario

tablet

fabricante / nombre comercial

USP

concentración

10 mg/tablet (nominal prednisone content per tablet)

aplicaciones

pharmaceutical

Formato

mixture

temp. de almacenamiento

room temp

Descripción general

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.

Aplicación

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.

Componentes

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)

Nota de análisis

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.

Otras notas

Sales restrictions may apply.

Pictogramas

Health hazard
GHS08

Palabra de señalización

Warning

Frases de peligro

H373

Consejos de prudencia

P260 - P314 - P501

Clasificaciones de peligro

STOT RE 2 Inhalation

Código de clase de almacenamiento

11 - Combustible Solids

Clase de riesgo para el agua (WGK)

WGK 3

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Certificados de análisis (COA)

Lot/Batch Number

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Questions

1–2 of 2 Questions  

  1. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer

    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

      Helpful?

  2. How can I determine the shelf life / expiration / retest date of this product?

    1 answer

    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/449/386/product-dating-information-mk.pdf

      Helpful?

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