C13H16N2O2
The main dosage forms are melatonin tablets, melatonin hard capsules, melatonin soft capsules, and melatonin gummies.
Melatonin powder
ITEM |
STANDARD |
Appearance |
A white to off-white crystalline powder. |
Solubility |
Slightly soluble in water,soluble in acetone, ethyl acetate and methanol |
Identification |
IR |
UV |
|
HPLC |
|
Chloride and sulfate |
0.02% MAX |
Loss on drying |
1.0% MAX |
Residue on ignition |
0.1% MAX |
Melting range |
117-120℃ |
Particle size |
98% through 80 mesh |
Total Plate Count |
1000 cfu/g MAX |
Yeasts & Molds |
100 cfu/g MAX |
E.Coli |
Absent/10g |
Salmonella |
Absent/10g |
S.aureus |
Absent/10g |
Residual solvents(Ethanol) |
1000ppm MAX |
Tap density |
0.45g/mL MIN |
Bulk density |
0.35g/mL MIN |
Clarity and degree of opalescence of liquids |
Clear in the 1% melatonin solution of ethanol or chloroform |
Total Heavy metals |
10ppm MAX |
Pb |
1ppm MAX |
As |
1ppm MAX |
Hg |
0.1ppm MAX |
Cd |
0.5ppm MAX |
Individual impurity |
0.1% MAX |
Total impurity |
1.0% MAX |
Assay(on the dried basis) |
98.5~101.5% |
Sales Office:
Wuhan Ability chemical technology Co., Ltd.
Add:No 518 Qingnian Rd., Jianghan, Wuhan, Hubei Province, 430024, P.R.China.
Tel:0086-27-85788889
E-mail: sales@lthxy.com
Copyright(C)2023, Luotian Xinpusheng Pharmaceutical Co., Ltd. All Rights Reserved. Supported by ChemNet
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