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 90.0percent of the labeled amount of USP Hyaluronidase Units.Hyaluronidase Injection contains not more than 0.25µg 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 Iglass,and store in a refrigerator.
Bacterial endotoxins á85ñ—
It contains not more than 2.30USP Endotoxin Units per USP Hyaluronidase Unit.
pHá791ñ:
between 6.4and 7.4.
Limit of tyrosine—
Transfer an accurately measured volume,equivalent to about 120USP Hyaluronidase Units,to a 15-mLcentrifuge tube calibrated at 6mL,and evaporate at 105
to dryness.Proceed as directed in Limit of tyrosineunder Hyaluronidase for Injection,beginning with “Add 200µLof 6Nsodium 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:
to dryness.Proceed as directed in Limit of tyrosineunder Hyaluronidase for Injection,beginning with “Add 200µLof 6Nsodium 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 AUand ASare the absorbances of the solution from the Injection and the Standard solution,respectively:not more than 0.25µg of tyrosine is found for each USP Hyaluronidase Unit.
Other requirements—
It meets the requirements under Injections á1ñ.
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 Procedurein 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—
Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 950
Pharmacopeial Forum:Volume No.29(5)Page 1505
Phone Number:1-301-816-8178