檢驗標(biāo)準(zhǔn)

Specification

企業(yè)標(biāo)準(zhǔn)

In-house

檢驗項目

Test Items

標(biāo)準(zhǔn)規(guī)定

Specification

檢驗結(jié)果

Results

    【性狀】Description

外觀

Appearance

白色結(jié)晶性粉末

White crystalline powder

白色結(jié)晶性粉末

White crystalline powder

熔點

Melting Point

192℃~196℃，熔融時分解

Degradation on Melting

194.5℃

比旋度

Specific Rotation

-149°~-151°（Water，C=0.1）

-150.2°

  【鑒別】Identification

   A. 化學(xué)鑒別Chemical

應(yīng)呈正反應(yīng)

Positive reaction

呈正反應(yīng)

Positive reaction

   B. 化學(xué)鑒別Chemical

應(yīng)呈正反應(yīng)

Positive reaction

呈正反應(yīng)

Positive reaction

   C. IR鑒別Infrared

應(yīng)與對照圖譜（光譜圖集693）一致

Should correspond to RS

符合規(guī)定

Conforms

【檢查】Test

酸度Acidity

pH between 2.0 and 3.0( 2.5mg/ml)

2.55

有 關(guān) 物 質(zhì)

Related Substance

NMT 1.0%

0.35%

干 燥 失 重

Loss on Drying

NMT 0.5%

0.21%

熾 灼 殘 渣

Residue on ignition

NMT 0.1%

Conforms

重  金  屬

Heavy metal

NMT 10ppm

Conforms

        殘留溶劑 Residual Solvent

甲醇 Methanol

NMT 3000ppm

Conforms

二氯甲烷

Dichloromethane

NMT 600 ppm

Conforms

【含量測定】Assay

按干燥品計算，含C₉H₁₂N₂O₄S不得少于98.5%

C₉H₁₂N₂O₄S NLT 98.5% on dryness basis

99.55%

檢驗結(jié)論

Conclusion

本品按企業(yè)標(biāo)準(zhǔn)檢驗，檢驗結(jié)果均符合規(guī)定。

It *plies with in-house Specification