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)
Sample List of Drugs Withdrawn for Safety Reasons or BBWed, with details and sources. From: Dan Carpenter, partial and incomplete as 20080325. Do not distribute without express approval of Dan A general note: It is very important, in pointing to these examples of pre-deadline approvals that later encountered safety problems, to understand the limitations of a statistical analysis.
Individual Plan Medical Underwriting Guidelines M U G Insurability Because of the potential additional risk associated with certain medical conditions, some Applicants will be declined for all coverages. However, based on underwriting evaluation PacifiCare Individual PPO plans may be offered at a 20 percent