Test items Standard Test result
Purity by HPLC 95% min 98.4%
Activity unit 1.0×105IU/mg min 1.2×105IU/mg
Appearance It is white and aerosols. Added into 1ml distilled water, it can solve quickly.
It should not contain insoluble matter seen by naked eyes. It is white and aerosols. Added into 1ml distilled water, it can solve quickly.
It does not contain insoluble matter seen by naked eyes.
pH value 6.0 - 6.6 6.2
Water residue ≤1.0% 0.6%
Abnormal toxicity exp. The tested animals have No abnormal
reactions. They keep healthy, and have weight increase. The tested animals have No abnormal reactions. They keep healthy, and have weight increase.
Sterility test No bacterial growth No bacterial growth