theophylline and substances related to diphenhydramine | the theophylline is not more than 0.5% | not detected |
any impurities is not more than 0.5% | not detected | |
heavy metals | Not more than 20ppm | <20ppm |
loss on drying | not more than 0.5% | 0.26% |
sulphated ash | not more than 0.2% | 0.07% |
assay for diphenhydramine | (calculated with reference to the dried substance) 53.0-55.5% | 55.22% |
assay for 8-chlorotheophylline | (calculated with reference to the dried substance) 44.0%-46.5% | 44.08% |
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