Melatonin is an indolamine that is produced in the pineal gland. Its chemical appellation is N-Acetyl-5-Methoxytryptamine or C13-H16-N2-O2.
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ITEMS
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STANDARDS
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RESULT
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Identification
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positive reaction
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comply
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Loss on drying
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MAX 0.5%
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0.18%
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Residue on ignition
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MAX 0.1%
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0.07%
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Heavy metal
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MAX10ppm
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comply
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Melting point
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117-120°C
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118.-119°C
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Clarity and degree of opalescence of liquids
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1%ethanol and chloroform
Solution
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comply
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Particle size
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80-120mesh
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comply
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related substances
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Max0.1%
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comply
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residual solvents: ethanol
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Max 1000ppm
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comply
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total viable count
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Max3000cfu/g
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comply
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yeast and moulds
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Max300cfg/g
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comply
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e. coli
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Absence/g
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comply
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salmonella
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Absence/25g
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comply
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HPLC
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≥99.5%
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99.55%
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Main Function:
1 Studies suggest that melatonin supplements may help induce sleep in people with disrupted circadian rhythms (such as those suffering from jet lag or poor vision or those who work the night shift) and those with low melatonin levels (such as some elderly and individuals with schizophrenia). A review of clinical studies suggests that melatonin supplements may help prevent jet lag, particularly in people who cross five or more time zones.
2 A few clinical studies suggest that when taken for short periods of time (days to weeks) melatonin is significantly more effective than a placebo, in decreasing the amount of time required to fall asleep, increasing the number of sleeping hours, and boosting daytime alertness.
3 Multiple human studies have measured the effects of melatonin supplements on sleep in healthy individuals. A wide range of doses has been used, often taken by mouth 30 - 60 minutes prior to sleep time. A study of 334 people aged 55 and older found that prolonged-release melatonin produced significant and clinically meaningful improvements in sleep quality, morning alertness, sleep onset latency, and quality of life in primary insomnia patients aged 55 years and over.
