Hyaluronidase Injection
» Hyaluronidase Injection is a sterile solution of dry, soluble enzyme product, prepared from mammalian testes and capable of hydrolyzing mucopolysaccharides of the type of hyaluronic acid, in Water for Injection. It contains not less than 90.0 percent of the labeled amount of USP Hyaluronidase Units. Hyaluronidase Injection contains not more than 0.25 µg of tyrosine for each USP Hyaluronidase Unit. It may contain suitable stabilizers.
Packaging and storage
Preserve in single-dose or multiple-dose containers, preferably of Type I glass, and store in a refrigerator.
Bacterial endotoxins 85
It contains not more than 2.30 USP Endotoxin Units per USP Hyaluronidase Unit.
pH 791:
between 6.4 and 7.4.
Limit of tyrosine
Transfer an accurately measured volume, equivalent to about 120 USP Hyaluronidase Units, to a 15-mL centrifuge tube calibrated at 6 mL, and evaporate at 105 to dryness. Proceed as directed in Limit of tyrosine under Hyaluronidase for Injection, beginning with Add 200 µL of 6 N sodium hydroxide, except to read Hyaluronidase Injection for Hyaluronidase for Injection in the second paragraph. Calculate the quantity, in µg, of tyrosine in the volume of Injection taken by the formula:
45(AU / AS)
in which AU and AS are the absorbances of the solution from the Injection and the Standard solution, respectively: not more than 0.25 µg of tyrosine is found for each USP Hyaluronidase Unit.
Other requirements
It meets the requirements under Injections 1.
Assay
Acetate buffer solution, Phosphate buffer solution, Hydrolyzed gelatin, Diluent for hyaluronidase solutions, Serum stock solution, Serum solution, Potassium hyaluronate stock solution, Hyaluronate solution, and Standard solution
Prepare as directed in the Assay under Hyaluronidase for Injection.
Assay preparation
Quantitatively dilute an accurately measured volume of Injection with cold Diluent for hyaluronidase solutions, on the basis of trial or experience, so that the observed absorbances with the three dilutions of the Injection fall on the upper, linear part of the standard curve prepared as directed in the Procedure.
Procedure
Proceed as directed for Procedure in the Assay under Hyaluronidase for Injection. The potency, in USP Hyaluronidase Units, of the portion of Injection taken is the average of the six activity values read from the standard curve.
Auxiliary Information
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USP32NF27 Page 2562
Pharmacopeial Forum: Volume No. 29(5) Page 1505
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