盐酸帕洛诺司琼主打

Items

检测项

Specifications

标准

Results

结论

Appearance

外观

White to off-white powder

白色至类白色粉末

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 的盐酸溶液，可溶于甲醇，

微溶于乙醇，几乎不溶于异丙醇

Conforms

符合

Identification

鉴别

IR

红外

Conforms

符合

HPLC

液相

Specific Optical Rotation

旋光度

-93.0°～-103.0°

-100.5°

PH

酸碱度

4.5 to 6.0

Conforms

符合

Loss On Drying

干燥失重

≤1.00%

0.07%

Residue On Ignition

灼烧残渣

≤0.10%

0.01%

Heavy Metals

重金属

≤20PPM

Conforms

符合

Any Single Impurity (HPLC)

任一其它未知单杂(HPLC)

≤0.50%

Conforms

符合

Total Impurities (HPLC)

总杂(HPLC)

≤1.00%

0.37%

Purity (HPLC)

纯度(HPLC)

≥99.0%

99.6%

Assay

含量

≥99.0%

99.5%

Total Aerobic Microbial Count

总需氧菌数

≤100 CFU/G

Conforms

符合

Total Yeast And Mould Count

总酵母和霉菌数

≤10 CFU/G

Conforms

符合

Endotoxins

内毒素

≤5 EU/MG

Conforms

符合

Conclusion

结论

Results conform with the enterprise standards

符合企标

Conclusion

结论