Action and use
Follicle-stimulating hormone.
DEFINITION
Urofollitropin Injection is a sterile solution of Urofollitropin in Sodium Chloride Infusion. It is prepared by dissolving Urofollitropin for Injection in the requisite amount of Sodium Chloride Infusion immediately before use.
The injection complies with the requirements stated under Parenteral Preparations.
STORAGE
Urofollitropin Injection should be used immediately after preparation.
UROFOLLITROPIN FOR INJECTION
DEFINITION
Urofollitropin for Injection is a sterile material consisting of Urofollitropin 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 80% and not more than 125% of the stated potency.
CHARACTERISTICS
An almost white or slightly yellow powder.
IDENTIFICATION
Causes enlargement of the ovaries of immature female rats when administered as directed in the Assay.
TESTS
Acidity or alkalinity
Dissolve the contents of the sealed container in 3 mL of water (solution A). The pH is 6.0 to 8.0, Appendix V L.
Clarity and colour of solution
Solution A is clear, Appendix IV A, and colourless, Appendix IV B, Method I.
Residual luteinising activity
Comply with the test described under Urofollitropin.
Water
Comply with the test described under Urofollitropin.
Bacterial endotoxins
Carry out the test for bacterial endotoxins, Appendix XIV C, using Method C. Dissolve the contents of the sealed container in water BET to give a solution containing 75 IU of urofollitropin per mL (solution A). The endotoxin limit concentration of solution A is 30 IU of endotoxin per mL. Carry out the test using a suitable dilution of solution A as described under Method C.
ASSAY
Carry out the Assay described under Urofollitropin. The fiducial limits of error are not less than 64% and not more than 156% of the stated potency.
STORAGE
The sealed container should be protected from light.
LABELLING
The label of the sealed container states the number of IU (Units) of follicle-stimulating hormone activity contained in it.
