產(chǎn)品名稱Product Name：L-脯氨酸L-PROLINE

批號Batch No.：231004

數(shù)量Quantity：1000KGS

生產(chǎn)日期Manufacture Date：10.04, 2023

有效期至Expiry Date：10.04, 2026

項目Items

標準Specifications

結(jié)果Results

外觀Appearance

白色結(jié)晶或結(jié)晶性粉末

White crystals or crystalline powder

Conforms

鑒別Identification

紅外圖譜

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%

硫酸鹽Sulfate(SO₄)

≤0.03%

<0.03%

鐵鹽Iron(Fe)

≤0.003%

<0.003%

重金屬Heavy metals(Pb)

≤0.0015%

<0.0015%

干燥失重Loss on drying

≤0.40%

0.05%

灼燒殘渣Residue on ignition

≤0.40%

0.06%

色譜純度

Chromatographic purity

單個雜質(zhì)不超過0.5%，總雜質(zhì)不超過2.0%

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

Not more than 2.0% of total impurities is found

Conforms

有機揮發(fā)物

Organic volatile impurities

應符合規(guī)定

Meets the requirements

Conforms

含量Assay

98.5~101.5%

99.6%

結(jié)  論：本批產(chǎn)品經(jīng)檢驗符合美國藥典USP32標準。

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