产品名称Product Name：L-脯氨酸L-PROLINE

批号Batch No.：231004

数量Quantity：1000KGS

生产日期Manufacture Date：10.04, 2023

有效期至Expiry Date：10.04, 2026

项目Items

标准Specifications

结果Results

外观Appearance

白色结晶或结晶性粉末

White crystals or crystalline powder

Conforms

鉴别Identification

红外图谱

Infrared Absorption

Conforms

比旋度Specific rotation [α]_D²⁵

-84.3°~ -86.3°

-85.0°

氯化物Chloride(Cl)

≤0.05%

<0.05%

硫酸盐Sulfate(SO₄)

≤0.03%

<0.03%

铁盐Iron(Fe)

≤0.003%

<0.003%

重金属Heavy metals(Pb)

≤0.0015%

<0.0015%

干燥失重Loss on drying

≤0.40%

0.05%

灼烧残渣Residue on ignition

≤0.40%

0.06%

色谱纯度

Chromatographic purity

单个杂质不超过0.5%，总杂质不超过2.0%

Not more than 0.5% of any individual impurity is found；

Not more than 2.0% of total impurities is found

Conforms

有机挥发物

Organic volatile impurities

应符合规定

Meets the requirements

Conforms

含量Assay

98.5~101.5%

99.6%

结  论：本批产品经检验符合美国药典USP32标准。

Conclusion：This Batch Is Conforming With The Standard Of USP32.