分析項目

ITEM OF ANALYSIS

標準

STANDARD

性狀Appearance

白色或類白色粉末White or almost white crystalline powder

溶解度

Solubility

幾乎不溶于水,易溶于二甲亞砜,微溶于二氯甲烷

Practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride

熔點

Melting point

302℃~303℃

鑒別

Identification

紅外圖譜與參照圖譜一致

The infrared absorption spectrum is concordant with the reference spectrum

供試品溶液中主峰的保留時間應與鑒別溶液中主峰的保留時間一致

The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution

比旋度

Rotation

+ 78.0°to + 84.0°

雜質A,B,C

Impurities A, B and C

雜質 A, B and C≤0.1%

Impurity  A, B and C≤0.1%

干燥失重

Loss on drying

≤0.5%

熾灼殘渣

Residue on ignition

≤0.1%

重金屬

Heavy metals

≤10ppm

有關物質（HPLC）

Related substances

單項雜質≤0.1%

Individual impurity≤0.1%

總雜質≤0.3%

Total unknown impurity≤0.3%

殘留溶劑

Residual Solvents

甲醇≤0.3%

Methanol;≤0.3%

乙酸乙酯≤0.5%

EA≤0.5%

異丙醇≤0.5%

IPA≤0.5%

乙酸甲酯≤0.5%

Methyl acetate≤0.5%

二氯甲烷≤0.06%

DCM≤0.06%

醋酸≤0.5%

AceticAcid≤0.5%

含量Assay

98% ~ 102.0 % (干品計dried substance).

結論

Conclusion

本品按EP 9/USP40標準檢驗，結果符合規(guī)定。

The test results conform with EP 9/USP40 Specification.