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ASTM E2253-11
Standard Test Method for Temperature and Enthalpy Measurement Validation of Differential Scanning Calorimeters
7 стр.
Заменен
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96.72 $ (включая НДС 20%)
Разработчик:
Зарубежные/ASTM
ICS:
17.200.10 Heat. Calorimetry / Тепло. Калориметрия
Сборник (ASTM):
14.05 Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of Pharmaceutical and Biopharmaceutical Products / Статистические методы; Потенциальная опасность химических веществ; Измерения теплопроводности; Производство фармацевтических изделий
Тематика:
Thermal Analysis
Описание
Значение и использование

This test method may be used to determine and validate the performance of a particular DSC apparatus.

This test method may be used to determine and validate the performance of a particular method based upon a DSC temperature and enthalpic measurement, or both.

This test method may be used to determine the repeatability of a particular apparatus, operator, or laboratory.

This test method may be used for specification and regulatory compliance purposes.

Область применения

1.1 This test method provides procedures for validating temperature and enthalpy measurements of differential scanning calorimeters (DSC) and analytical methods based upon the measurement of temperature or enthalpy (or heat), or both, by DSC. Performance parameters determined include temperature and calorimetric repeatability (precision), detection limit, quantitation limit, linearity, and bias. This test method is applicable to exothermic events.

1.2 Validation of apparatus performance and analytical methods is requested or required for quality initiatives or where results may be used for legal purposes.

1.3 The values stated in SI units are to regarded as standard. No other units of measurement are included in this standard.

1.4 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.

Ключевые слова:
detection limit; differential scanning calorimetry; enthalpy; linearity; precision; quantitation limit; range; repeatability; thermal analysis; validation; Calorimeter; Detection method; Differential scanning calorimetry (DSC); Endothermic temperature analysis; Enthalpy; Exothermic temperature analysis; Heat flow; Linear changes/linearity; Quantitation estimate; Repeatability/reproducibility (RR); Thermal analysis (TA); Validation