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ASTM E2503-07
Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
Automaticky preložený názov:
Štandardná prax pre Kvalifikácia koše a pádlo rozpúšťacím zariadení
NORMA vydaná dňa 15.3.2007
Informácie o norme:
Označenie normy: ASTM E2503-07
Poznámka: NEPLATNÁ
Dátum vydania normy: 15.3.2007
Kód tovaru: NS-45447
Počet strán: 4
Približná hmotnosť: 12 g (0.03 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Anotácia textu normy ASTM E2503-07 :
Keywords:
basket dissolution apparatus, calibration, paddle dissolution apparatus, ICS Number Code 11.120.99 (Other standards related to pharmaceutics)
Doplňujúce informácie
| Significance and Use |
|
This practice outlines a procedure for the mechanical calibration of paddle and basket dissolution units to ensure reproducibility of results. Once a unit meets all of the mechanical specifications included in this practice, it is considered calibrated and further calibration with dissolution calibrator tablets is not required. |
| 1. Scope |
|
1.1 This practice covers the set-up and calibration of the paddle and basket dissolution apparatus. 1.2 Use of this practice may be applied to apparatus that have been modified to enable automatic dissolution testing (that is, a valve in the bottom of the vessel or sampling through the shaft). 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. |
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