items

standard

result

description

white or almost white crystalline， hygroscopic powder

conforms

identification

（a）(b)(c)according to criterions

conforms

solubility

soluble in water, slightly or freely soluble in ethanol（96%）

conforms

acidity or alkalinity

ph according to criterions

conforms

appearance and color of solution

according to criterions

conforms

loss on drying

≤2.0%

0.98%

related substances

total impurity ≤0.3%

any impurity ≤0.1%

0.15%

0.06%

sulfate(so4)

≤200ppm

conforms

heavy metals

≤20ppm

conforms

assay

98.5～101.0%

99.3%

content of chloride(cl)

≤200ppm

conforms

conclusion

this batch is conforming with the standard of bp2009. the above items meet the requirement