Melatonin BP2015

品名：褪黑素                                                 数量：300KG

Product name: Melatonin                                         Quantity:

药典依据：美国药典38版                                       批号： 160701

Standard: USP38                                                Lot NO:

性状：白色至类白色结晶粉末，微溶于水，溶于丙酮、乙酸乙酯和甲醇。

Characteristics: A white to off-white crystalline powder. Slightly soluble in water,soluble in acetone, ethyl acetate and methanol

生产日期：2016.07.01                                           有效日期:2018.06.30

Manufacturing Date:                                              Expiry Date:

储藏条件：遮光密闭保存。

Packaging and Storage: Preserve in tight containers, protected from light..

化 验 结 果

RESULT  OF  ANALYSIS

检验项目

ITEM

检验标准

STANDARD

检验结果

RESULT

鉴定

Identification

红外

IR

符合

Conform

紫外

UR

符合

Conform

高效液相色谱

HPLC

符合

Conform

氯离子和硫酸根离子

Chloride and sulfate

0.02%MAX

<0.02%

干燥失重

Loss on drying

1.0%MAX

0.10%

炽灼残渣

Residue on ignition

0.1%MAX

0.04%

重金属

Heavy metals

20ppmMAX

Conform

杂质

Impurities

单杂

Individual impurity

0.1%MAX

0.071%

总杂

Total impurity

1.0%MAX

0.68%

含量（干基）

Assay(on the dried basis)

98.5~101.5%MIN

99.13%

结论：本品符合美国药典38标准

CONCLUSION: COMPLY WITH THE REQUIREMENTS OF USP38.