2011年8月17日星期三

Expression of Standards

Expression of Standards
Where the standard for the content of a substance described in a monograph is expressed in terms of the chemical formula for that substance an upper limit exceeding 100% may be stated. Such an upper limit applies to the result of the assay calculated in terms of the equivalent content of the specified chemical formula. For example, the statement 'contains not less than 99.0% and not more than 101.0% of C20H24N2O2,HCl' implies that the result of the assay is not less than 99.0% and not more than 101.0%, calculated in terms of the equivalent content of C20H24N2O2,HCl.
Where the result of an assay or test is required to be calculated with reference to the dried, anhydrous or ignited substance, the substance free from a specified solvent or to the peptide content, the determination of loss on drying, water content, loss on ignition, content of the specified solvent or peptide content is carried out by the method prescribed in the relevant test in the monograph.

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