Time

Solvent

Temperature

Revolutions

Sample feeding amount

0-2h

900mL,0.1moL/Hydrochloric acid solution

37℃

60 rpm

12mg

2-8h

1L,PH=6.8 buffer

(900mL 0.1moL/Hydrochloric acid solution

+100mL Sodium phosphate solution)

Dissolution studies have shown that:

Sustained-release melatonin releases 40% of the dose within 1 hour, gradually releases 50% of the total dose over the next 5 hours, and 10% after 7 hours. This makes it ideal for both falling asleep instantly and staying asleep.

Tests

Units

Limits

Methods

Appearance

White to off-white powder

Visual

Bulk Density

g/mL

0.40-0.70

USP <616>

Particle Size（through 40 mesh）

%

≥95.0

USP <786>

Loss on Drying

%

≤1.0

USP <731>

Total Heavy Metals (as Pb)

ppm

≤10

USP<231>

Lead

ppm

≤1.00

USP <233>

Arsenic

ppm

≤1.00

USP <233>

Cadmium

ppm

≤1.00

USP <233>

Mercury

ppm

≤0.100

USP <233>

Total Plate Count

CFU/g

≤1,000

ISO 4833-1

Yeasts

CFU/g

≤50

ISO 21527

Molds

CFU/g

≤50

ISO 21527

Coliform

CFU/g

≤10

ISO 4832

E. coli

/g

Negative

ISO 16649-3

Salmonella

/25g

Negative

ISO 6579-1

Staphylococcus aureus

/25g

Negative

ISO 6888-3

Assay(on the dried basis)

%

≥50

Enterprise standard