BP 2025 (Ph. Eur. 11.6 update)
Action and use
Used to promote absorption of fluid into tissues.
DEFINITION
Hyaluronidase Injection is a sterile solution of Hyaluronidase in Water for Injections. It is prepared by dissolving Hyaluronidase for Injection in the requisite amount of Water for Injections immediately before use.
The injection complies with the requirements stated under Parenteral Preparations.
STORAGE
Hyaluronidase Injection should be used immediately after preparation.
HYALURONIDASE FOR INJECTION
DEFINITION
Hyaluronidase for Injection is a sterile material consisting of Hyaluronidase with or without excipients. It is supplied in a sealed container.
The contents of the sealed container comply with the requirements for Powders for Injections or Infusions stated under Parenteral Preparations and with the following requirements.
Potency
The estimated potency is not less than 90% and not more than 115% of the stated potency.
IDENTIFICATION
A solution containing 100 IU in 1 mL of a 0.9% w/v solution of sodium chloride depolymerises an equal volume of a 1% w/v solution of sodium hyaluronate EPBRP at 20° in 1 minute, as shown by a pronounced decrease in viscosity. This action is destroyed by heating the initial solution at 100° for 30 minutes.
TESTS
Acidity or alkalinity
pH of a 0.3% w/v solution in carbon dioxide-free water, 4.5 to 7.5, Appendix V L.
Clarity and colour of solution
A 1.0% w/v solution in carbon dioxide-free water is clear, Appendix IV A, and not more than faintly yellow.
Bacterial endotoxins
Carry out the test for bacterial endotoxins, Appendix XIV C. Dissolve the contents of the sealed container in water BET to give a solution containing 150 IU of Hyaluronidase per mL (solution A). The endotoxin limit concentration of solution A is 30 IU per mL.
ASSAY
Carry out the Assay described under Hyaluronidase.
LABELLING
The label of the sealed container states the total number of IU (Units) contained in it.
