VI. A method to determine an antibiotic was developed and validated in a pharmaceutical company. The method allows analysis of 100 mg tablets containing 7.5 mg of the antibiotic. According to the validation data, the confidence limits are 7.50 mg ± 0.04mg. How many samples will need to be analyzed for an analyst to ensure that the antibiotic content in a macerated sample of that drug is 7.50 mg ± 0.03 mg with 95% reliability when analyzing 100 mg of the sample? macerated?

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VI. A method to determine an antibiotic was
developed and validated in a pharmaceutical
company. The method allows analysis of 100 mg
tablets containing 7.5 mg of the antibiotic.
According to the validation data, the confidence
limits are 7.50 mg + 0.04mg. How many samples
will need to be analyzed for an analyst to ensure
that the antibiotic content in a macerated sample
of that drug is 7.50 mg + 0.03 mg with 95%
reliability when analyzing 100 mg of the sample?
macerated?
Transcribed Image Text:VI. A method to determine an antibiotic was developed and validated in a pharmaceutical company. The method allows analysis of 100 mg tablets containing 7.5 mg of the antibiotic. According to the validation data, the confidence limits are 7.50 mg + 0.04mg. How many samples will need to be analyzed for an analyst to ensure that the antibiotic content in a macerated sample of that drug is 7.50 mg + 0.03 mg with 95% reliability when analyzing 100 mg of the sample? macerated?
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