Penicillin G Procaine Injectable Suspension
»Penicillin G Procaine Injectable Suspension is a sterile suspension of Penicillin G,Procaine or,where labeled for veterinary use only of sterile penicillin Gprocaine,in Water for Injection and contains one or more suitable buffers dispersants,or suspending agents,and a suitable preservative.It may contain procaine hydrochloride in a concentration not exceeding 2.0percent,and may contain one or more suitable stabilizers.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of penicillin G,the labeled amount being not less than 300,000Penicillin G Units per mLor per container.
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Ior Type IIIglass,in a refrigerator.
Labeling— Where it is intended for veterinary use only,the label so states.
Identification— It responds to the Identificationtest under Penicillin G Procaine.
Crystallinity á695ñ(where it is prepared from penicillin Gprocaine and is labeled for veterinary use only): meets the requirements,the dried residue prepared as directed in the test forPencillin Gand procaine contents being used.
Bacterial endotoxins á85ñ— It contains not more than 0.01USP Endotoxin Unit per 100Penicillin G Units.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,except to use a portion of specimen from each container equivalent to 300,000Penicillin G Units,instead of the minimum volume specified in the Table 2,Minimum Quantity to be Used for Each Medium,and to use Fluid Ato which has been added sufficient sterile penicillinase to inactivate the penicillin Gand to swirl the vessel until solution is complete before filtering.If the Injectable Suspension contains lecithin,use Fluid D.If it contains carboxymethylcellulose sodium,add sufficient sterile carboxymethylcellulase to Fluid Aor Fluid Dto dissolve the carboxymethylcellulose sodium before filtering.If it does not dissolve completely,proceed as directed for Direct Inoculation of the Culture Medium under Test for Sterility of the Product to be Examined,except to use Fluid Thioglycollate Medium and Soybean–Casein Digest Medium containing an amount of sterile penicillinase sufficient to inactivate the penicillin Gin each vessel.
pHá791ñ: between 5.0and 7.5.
Penicillin Gand procaine contents (where it is prepared from penicillin Gprocaine and is labeled for veterinary use only)— Dilute a portion of it,equivalent to about 300,000Penicillin G Units,with water to obtain a volume of 10mL,centrifuge,and remove and discard the supernatant.Resuspend the sediment in 10mLof water,centrifuge,and remove and discard the supernatant.Dry the sediment in a vacuum desiccator containing silica gel for 18hours at a temperature not exceeding 25.The dried material meets the requirements of the test for Penicillin Gand procaine contentsunder Penicillin G Procaine.[NOTE—Reserve a portion of the dried material for the test for Crystallinity.]
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Standard preparation— Using USP Penicillin G Potassium RS,prepare as directed for Standard preparationunder Iodometric Assay—Antibiotics á425ñ.
Assay preparation 1 (where it is represented as being in a single-dose container)—Withdraw all of the withdrawable contents of the Injectable Suspension,using a suitable hypodermic needle and syringe,and dilute quantitatively with Buffer No.1to obtain a solution containing about 2000Penicillin G Units per mL.Pipet 2mLof this solution into each of two glass-stoppered,125-mLconical flasks.
Assay preparation 2 (where the label states the quantity of penicillin Gprocaine in a given volume of Injectable Suspension)—Dilute an accurately measured volume of Injectable Suspension quantitatively with Buffer No.1to obtain a solution containing about 2000Penicillin G Units per mL.Pipet 2.0mLof this solution into each of two glass-stoppered,125-mLconical flasks.
Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ.Calculate the quantity,in Penicillin G Units,in the container,or in the portion of Injectable Suspension taken,by the formula:
(L/2D)(F)(B-I),
in which Lis the labeled quantity in Penicillin G Units,in the container,or in the volume of Injectable Suspension taken;and Dis the concentration,in Penicillin G Units per mL,of Assay preparation 1,or of Assay preparation 2,on the basis of the labeled quantity in the container,or in the portion of Injectable Suspension taken,respectively,and the extent of dilution.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1491
Pharmacopeial Forum:Volume No.28(4)Page 1176
Phone Number:1-301-816-8335