ParametersResults
Osmolality (mOsm/L)9188±203
pH5.15±0.02
Enzyme physiological activity expected (IU/mL) (37°C, pH=4.5)2822±22
Enzyme activity in qualification conditions (IU/mL) (55°C, pH=4.5)6172±87
SterilityNo bacteria or fungus after 10 days of culture
Residuals solventsEthanol (4 mg/L), no solvent under C8
Abnormal toxicityNo lethality in mice according to the European Pharmacopoeia