Microsoft word - endotoxin limits.doc

USP Endotoxin Limits for Common Injectables Product name Endotoxin
Limit Endotoxin
Endotoxin Limit 3
(where applicable) (where applicable)
total dose in ml at the expiration time) Suspension Amphotericin B for Injection 5 EU/mg for parenterals (1mg of mix of amp & sulb -0.67 and 0.33 mg, respectively) Phosphate Dextrose Solution Anticoagulant Heparin Solution Anticoagulant Sodium Citrate 5.56 EU/ml Atracurium Besylate Injection 5.56 EU/mg labeled sterile or processed into injectable Chloride Injection Bacteriostatic Water for Phosphate and Betamethasone Acetate Injectable Suspension Betamethasone Sodium Phosphate Injection Bethanechol Chloride Bupivacaine Hydrochloride in 1.8 EU/mg Bupivacaine Injection
C
Benzoate Injection Calcium Chloride Injection Hydrochloride for Injection Chloroquine Hydrochloride Hydrochloride Injection Chorionic Gonadotropin Oxide, and Sodium Carbonate Irrigation Clavulanate Potassium Corticotropin Zinc Hydroxide 3.1 EU / USP Corticotropin dilution; mix .1ml with .1ml LAL reagent on vortex mixer Injection Desoxycorticosterone Acetate 71.4 EU/mg Injectable Suspension Dexamethasone Injection Injections containing less th Injections containing Diatrizoate Sodium Injection Injections containing less th for Injections contain Injections containing less th for Injections contain Diatrizoate Sodium Injection 5.6 EU/ml for Injections Injections containing Injections containing Injection Dicyclomine Hydrochloride In 17.2 EU/mg Diphosphate Injection Diethylstilbestrol Injection Injection Dihydrostreptomycin Sulfate no limit listed but USP for use in coating containers that come in contact with articles for parenteral use. (Mix 1ml of Dimethicone with 4ml of polydimethylsiloxane having a viscosity of 0.65 centistokes, by mixing on a vortex mixer for 1min. in an extraction tube. Add 10ml water, and mix on a vortex mixer for not less than 60 minutes. Allow layers to separate, and use lower aqueous layer as test Injection Dopamine Hydrochloride and 16.67 EU/mg of dopamine Extended Insulin Human Zinc 80 EU / 100 USP Insulin Injection Fludeoxyglucose 18F Injection 175/V EU/ml (V = max. total dose in ml at the expiration time) Flunixin Meglumine Injection 4.54 EU/mg of flunixin total dose in ml at the expiration time) Injection Gallium Citrate 67Ga Injection 175/V EU/ml (V = max. total dose in ml at the expiration time) Hydrochloride Injection Hydroxocobalamin Injection 0.4 EU/ug Injection
I
total dose in ml at the expiration time) total dose in ml at the expiration time) total dose in ml at the expiration time) Technetium 99Tcm Albumin Aggregated Injection total dose in ml at the expiration time) Iothalamate Sodium Injection Iothalamate Meglumine Isophane Insulin Suspension 80 EU / 100 USP Insulin Injection
K
Injection
L
Dextrose Injection Lactated Ringer's Injection Lidocaine Hydrochloride and 1.1 EU/mg of Lidocaine Lidocaine Hydrochloride and 0.7 EU/mg of Lidocaine Manganese Chloride Injection 0.45 EU/ug of Manganese Manganese Sulfate Injection 0.45 EU/ug of Manganese Hydrochloride for Injection Menadiol Sodium Diphosphate Injection Menadione Injection and Levonordefrin Injection Hydrochloride Mepivacaine Hydrochloride total dose in ml at the expiration time) total dose in ml at the expiration time) Metoprolol Tartrate Injection 25.0 EU/mg and Dextrose Injection Morphine Sulfate Injection Dextrose Injection Type 2 Multiple Electrolytes and Dextrose Injection Type 3 Multiple Electrolytes and Dextrose Injection Type 4 Multiple Electrolytes and Dex 0.5 EU/ml trose Injection Type 1 Multiple Electrolytes Injection 0.5 EU/ml Type 1 Multiple Electrolytes Injection 0.5 EU/ml Injectable Suspension Penicillin G Benzathine Dihydrostreptomycin Sulfate Units Injectable Suspension Penicillin G Procaine for Dihydrostreptomycin Sulfate, Units and Prednisolone Injectable Chlorpheniramine Maleate, and Dexamethasone Injectable Suspension Penicillin G Sodium Microspheres for Injection Perflutren Protein-Type A Injection Phenytoin Sodium Injection 0.3 EU/mg Chloride Injection Potassium Chloride in Dextrose Injection Potassium Chloride in Lactated Ringer's and Dextrose Injection Potassium Chloride in Sodium Chloride Injection Potassium Phosphates Succinate for Injection Prednisolone Tebutate Injectable Suspension Prednisone Injectable Levonordefrin Injection Procaine Hydrochloride Levonordefrin Injection Propoxycaine and Procaine Norepinephrine Bitartrate Injection Propranolol Hydrochloride Injection
Q
Ranitidine in Sodium Chloride 7 EU/mg of ranitidine total dose in ml at the expiration time) Samarium 153Sm Lexidronam 175/V EU/ml (V = max. total dose in ml at the expiration time) Sodium Acetate 11C Injection 175/V EU/ml (V = max. total dose in ml at the expiration time) of sodium chloride is 0.5% - mount of sodium total dose in ml at the expiration time) Sodium Fluoride 18F Injection 175/V EU/ml (V = max. Injection Sodium Pertechnetate 99Tcm 175/V EU/ml (V = max. tota Suspension Spectinomycin Hydrochloride 0.09 EU/mg of spectinomycin if labeled sterile or processed into Hydrochloride Sterile Water for Inhalation total dose in ml at the expiration time) labeled sterile or processed into injectable Injection
T
Technetium 99Tcm (Pyro- and 175/V EU/ml (V = max. total dose in ml at the expiration time) total dose in ml at the expiration time) total dose in ml at the expiration time) Technetium 99Tcm Etidronate 175/V EU/ml (V = max. total dose in ml at the expiration time) Technetium 99Tcm Gluceptate 175/V EU/ml (V = max. total dose in ml at the expiration time) Technetium 99Tcm Medronate 175/V EU/ml (V = max. total dose in ml at the expiration time) Technetium 99Tcm Mertiatide 175/V EU/ml (V = max. total dose in ml at the expiration time) Technetium 99Tcm Pentetate 175/V EU/ml (V = max. total dose in ml at the expiration time) Technetium 99Tcm Red Blood 175/V EU/ml (V = max. total dose in ml at the expiration time) total dose in ml at the expiration time) Terbutaline Sulfate Injection 1250 EU/mg Dextrose Injection Tetracaine Hydrochloride Thiothixene Hydrochloride for 88 EU/mg of thiothixene Injection Ticarcillin and Clavulanic Acid 0.07 EU/mg of ticarcillin for Injection Ticarcillin and Clavulanic Acid 0.07 EU/mg of ticarcillin labeled sterile or processed into injectable sodium if labeled sterile or processed into injectable Injectable Suspension Triamcinolone Diacetate Injectable Suspension Triamcinolone Hexacetonide Injectable Suspension Trifluoperazine Hydrochloride 172 EU/mg of Hydrochloride Injection Trimethobenzamide Hydrochloride Injection Tromethamine for Injection Injection
U
Injection Vincristine Sulfate Injection 62.5 EU/mg Injection
W
total dose in ml at the expiration time)

Source: http://www.qimedical.com/pdf/Endotoxin_Limits_Document_2011.pdf