Subject: Identity Library pharm. A NIR Identity Library has been developed using the ХХХ forInjection formulation samples listed in [Table 3.2.P.5.3.3-0517-injectable: 1] |
Прошу прощения,не то предложение привела, пожалуйста, помогите с переводом вот этого - "To account for possible NIR spectral variation associated with the orientation of a sample, several samples were measured with varying sample presentation." |
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link 25.09.2009 9:55 |
У Вас речь идет о БИК-спектрометрии, а этот метод, насколько я знаю, позволяет снимать спектр порошка прямо во флаконе. Или в Вашем случае порошок высыпают из флакона? Описана ли в методике пробоподготовка? Не совсем понятно, что имеется в виду под "sample presentation". |
ЕЩЕ контекст. Spectral matching is done using spectral correlation which is a statistical measure of the degree of similarity between two spectra and is sensitive to peak position, peak shape and the relative peak intensities within a spectrum. For identification, the correlation coefficient between the unknown spectrum and the reference spectrum of the formulation is computed. The sample is positively identified as ХХХ for Injection when the correlation coefficient equals or exceeds the correlation threshold (default value 0.95). In the event that the correlation coefficient is less than 0.95, the method fails to identify the sample. A NIR Identity Library has been developed using the ХХХ for Injection formulation samples listed in [Table 3.2.P.5.3.3-0517-injectable: 1]. To account for possible NIR spectral variation associated with the orientation of a sample, several samples were measured with varying sample presentation. The NIR identity method has been validated for specificity, precision, and robustness as described below. The identification library was built using the 150 mg/vial image of ХХХ for Injection formulation. Internal specificity was determined using the 150 mg/vial image. External specificity was demonstrated using the 90 mg/vial and 115 mg/vial images along with several other Merck & Co., Inc. products. |
порошок из флакона не высыпали, получен "through the bottom of the vial" |
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link 25.09.2009 12:45 |
"using the ХХХ for Injection formulation samples listed in [Table 3.2.P.5.3.3-0517-injectable: 1]" А вот эти образцы, приведенные в таблице, чем различаются? |
Образцы, приведенные в таблице имеют различный номер и наименование, одинаковую дозировку и серию... спасибо за информацию, чувствую много пробелов в моих познаниях, спасибо за помощь. |
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