Product Name

Melatonin

(N-Acetyl-5-Methoxytryptamine)

Batch No.

20201201

CAS No.

73-31-4

Formula

C₁₃H₁₆N₂O₂

MFG. Date

Dec 10,2020

Exp Date

Dec 09,2022

Quantity

300kgs

Ref. Standard

Enterprise Standard

ITEMS

METHOD

SPECIFICATIONS

RESULTS

Description

Visual Inspection

Off-White to white crystalline powder

Conforms

Identification

IR

Conforms to reference

Conforms

Chromatographic

TLC

No secondary spot and identical Rf to reference

Conforms

Assay

HPLC Melatonin

HPLC Impurities

Peak E

≥99.0%

Total≤1.0%

Absent

99.5%

Not Detected

Absent

Sulphated Ash

USP

≤0.1%

0.04%

Heavy Metals

USP

≤10ppm

＜10ppm

Arsenic

USP

≤1ppm

＜1ppm

Loss on Drying

USP

≤0.2%

0.05%

Melting Point

USP

117～119^oC

117～118 ^oC

Bulk Density

USP

g/ml

0.44g/ml

Tap Density

USP

g/ml

0.62g/ml

Particle Size

USP

100% through 40 mesh

Conforms

Residual Solvents

Ethyl Acetate

USP

Absent

Absent

Acetic Acid

USP

Absent

Absent

Ethanol

USP

≤50ppm

200ppm

Microbiological Analysis

Total plate counts

USP

≤1000cfu/g

＜1000cfu/g

Yeast and Mold

USP

≤100cfu/g

＜100cfu/g

E.Coli

USP

Negative

Negative

Staphylococcus

USP

Negative

Negative

salmonella

USP

Negative

Negative