Items

檢測(cè)項(xiàng)

Specifications

標(biāo)準(zhǔn)

Results

結(jié)論

Appearance

外觀

White to off-white powder

白色至類白色粉末

Conforms

符合

Solubility

可溶性

Freely soluble in water and in 0.1M HCL, soluble in methanol, sparingly soluble in ethanol and practically insoluble in isopropyl alcohol

易溶于水和 0.1M 的鹽酸溶液，可溶于甲醇，

微溶于乙醇，幾乎不溶于異丙醇

Conforms

符合

Identification

鑒別

IR

紅外

Conforms

符合

HPLC

液相

Specific Optical Rotation

旋光度

-93.0°～-103.0°

-100.5°

PH

酸堿度

4.5 to 6.0

Conforms

符合

Loss On Drying

干燥失重

≤1.00%

0.07%

Residue On Ignition

灼燒殘?jiān)?/p>

≤0.10%

0.01%

Heavy Metals

重金屬

≤20PPM

Conforms

符合

Any Single Impurity (HPLC)

任一其它未知單雜(HPLC)

≤0.50%

Conforms

符合

Total Impurities (HPLC)

總雜(HPLC)

≤1.00%

0.37%

Purity (HPLC)

純度(HPLC)

≥99.0%

99.6%

Assay

含量

≥99.0%

99.5%

Total Aerobic Microbial Count

總需氧菌數(shù)

≤100 CFU/G

Conforms

符合

Total Yeast And Mould Count

總酵母和霉菌數(shù)

≤10 CFU/G

Conforms

符合

Endotoxins

內(nèi)毒素

≤5 EU/MG

Conforms

符合

Conclusion

結(jié)論

Results conform with the enterprise standards

符合企標(biāo)

Conclusion

結(jié)論