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USP Endotoxin Limits for Common Injectables

Updated as of August 2011 For reference use only Pharma&Biotech Updated as of August 2011. For reference use only. USP Endotoxin Limits This information is subject to the disclaimer included on page 13. for Common Injectables

This table is for informational purposes only. Endotoxin limits should be set on an individual product basis, using the formula found in the Pharmacopeias (Endotoxin Limit = K/M).

Description Endotoxin Limit A Acepromazine Maleate Injection 4.5 EU / mg Acetazolamide for Injection 0.5 EU / mg Acetic Acid Irrigation 0.5 EU / ml Acyclovir for Injection 0.174 EU / mg Adenosine Injection (continuous peripheral intravenous infusion) 5.95 EU / mg Adenosine Injection (rapid intravenous) 11.62 EU / mg in Dextrose Injection 0.5 EU / ml Alfentanil Injection 10 EU / ml Alprostadil Injection 0.05 EU / µg Alteplase for Injection 1 EU / mg Amifostine for Injection 0.2 EU / mg Amikacin Sulfate Injection 0.33 EU / mg Aminocaproic Acid Injection 0.05 EU / mg Aminohippurate Sodium Injection 0.04 EU / mg Aminopentamide Sulfate Injection 25 EU / mg Aminophylline Injection 1 EU / mg Ammonium Chloride Injection (of Chloride) 1.72 mEq Cl Amobarbital Sodium for Injection 0.4 EU / mg Amoxicillin, Sterile and Suspension 0.25 EU / mg Amphotericin B for Injection (for Intrathecal) 0.9 EU / mg Amphotericin B for Injection (for Parenterals) 5 EU / mg Ampicillin and Sulbactam for Injection 0.17 EU / (1 mg of mix of amp and sulb - 0.67 and 0.33 mg, respectively) Ampicillin for Injection 0.15 EU / mg Anileridine 7.2 EU / mg Aprotinin Injection 0.14 unit Arginine Hydrochloride Injection 0.01 EU / mg Ascorbic Acid Injection 1.2 EU / mg Atenolol Injection 33.3 EU / mg Atracurium Besylate Injection 5.56 EU / mg Atropine Sulfate 55.6 EU / mg of azathioprine Aurothioglucose Suspension 7.14 EU / mg Azathioprine Sodium for Injection 1 EU / mg Azithromycin for Injection 0.7 EU / mg Aztreonam for Injection 0.17 EU / mg if labeled sterile or processed into injectable B Bacitracin for Injection 0.01 EU / Bacitracin unit if labeled sterile or processed into injectable Bacteriostatic Sodium Chloride Injection 1 EU / ml Bacteriostatic Water for Injection (WFI), Sterile 0.5 EU / ml Benztropine Mesylate Injection 55.6 EU / mg Benzylpenicilloyl Polylysine Injection 5833 EU / ml Acetateand Betametthasone Sodium Phosphate injectable 29.2 EU / mg Suspension Betamethasone Sodium Phosphate 29.2 EU / mg Betamethasone

Customer Service: US 800 638 8174, EU + 32 87 321 611 ; Scientific Support: US 800 521 0390, EU +32 87 321 611 2 Updated as of August 2011. For reference use only. This information is subject to the disclaimer included on page 13.

Description Endotoxin Limit Bethanechol Chloride Injection 25 EU / mg Biperiden Lactate Injection 83.3 EU / mg Bleomycin for Injection 10 EU / Bleomycin Unit Bretylium Tosylate in Dextrose Injection 0.2 EU / mg Bretylium Tosylate Bretylium Tosylate Injection 0.2 EU / mg Brompheniramine Maleate Injection 35.7 EU / mg Bumetanide Injection 350 EU / mg Bupivacaine Hydrochloride and Epinephrine Injection 1.6 EU / mg Bupivacine Hydrochloride Bupivacaine Hydrochloride and Dextrose 1.8 EU / mg Bupivacine Hydrochloride Bupivacaine Hydrochloride Injection 2.5 EU / mg Butorphanol Tartrate Injection 88 EU / mg C and Injection 0.7 EU / mg Caffeine Citrated 0.25 EU / mg Calcitonin - Salmon 0.625 unit Calcitriol Injection 100 EU / µg Calcium Chloride 0.2 EU / mg Calcium Gluceptate Injection 0.32 EU / mg Calcium Gluconate 0.17 EU / mg Calcium Levulinate Injection 35.7 EU / mg Capreomycin for Injection 0.35 EU / mg Carbenicillin for Injection 0.05 EU / mg Carboplatin for Injection 0.54 EU / mg Carboprost Tromethamine 714.3 EU / mg Carmustine for Injection 0.95 EU / mg Cefamandole Nafate for Injection 0.15 EU / mg Cefamandole Cefazolin Injection 0.15 EU / mg Cefepime for Injection 0.06 EU / mg Cefepime Hydrochloride 0.04 EU / mg if labeled sterile or processed into injectable Cefmetazole for Injection 0.2 EU / mg Cefonicid for Injection 0.35 EU / mg Cefoperazone Injection 0.2 EU / mg Ceforanide 0.25 EU / mg if labeled sterile or processed into injectable Cefotaxime Sodium for Injection 0.2 EU / mg Cefotetan for Injection 0.17 EU / mg if labeled sterile or processed into injectable Cefoxitin for Injection 0.13 EU / mg Ceftazidime 0.1 EU / mg if labeled sterile or processed into injectable Ceftizoxime for Injection 0.1 EU / mg Ceftriaxone Injection 0.2 EU / mg Cefuroxime for Injection 0.1 EU / mg Cephalothin for Injection 0.13 EU / mg Cephapirin for Injection 0.17 EU / mg Cephradine for Injection 0.2 EU / mg Chloramphenicol Sodium Succinate 0.2 EU / mg of Chloramphenicol if labeled sterile or processed into injectable Chlordiazepoxide Hydrochloride 3.57 EU / mg Chloroquine Hydrochloride Injection 0.7 EU / mg Chlorothiazide Sodium 0.3 EU / mg Chlorpheniramine Maleate 8.8 EU / mg Chlorpromazine Hydrochloride 6.9 EU / mg Chorionic Gonadotropin 0.03 EU / USP Chorionic Gonadotropin Unit

Customer Service: US 800 638 8174, EU + 32 87 321 611 ; Scientific Support: US 800 521 0390, EU +32 87 321 611 3 Pharma&Biotech Updated as of August 2011. For reference use only. USP Endotoxin Limits This information is subject to the disclaimer included on page 13. for Common Injectables

Description Endotoxin Limit Chromate Sodium Cr5l Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Chromic Chloride Injection 16.7 EU / µg of chromium Chromic Phosphate P32 Suspension 175 / V EU / ml (V = max. total dose in ml at the expiration time) Chromium Cr 51 Edetate Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Cilastatin Sodium 0.17 EU / mg of cilastatin if labeled sterile Cimetidine Injection 0.5 EU / mg Ciprofloxacin for Injection 0.5 EU / mg Cisplatin for Injection 2 EU / mg Citric Acid, Magnesium Oxide and Sodium Carbinate Irrigation 2.8 EU / ml Clavulanate Potassium 0.03 EU / mg if labeled sterile or processed into injectable Clindamycin for Injection 0.58 EU / mg Cloprostenol Injection 2500 EU / mg Codeine Phosphate Injection 5.8 EU / mg Colchicine Injection 166.7 EU / mg Colistimethate for Injection 2 EU / mg if labeled sterile or processed into injectable Corticotropin Injection 3.1 EU / USP Corticotropin Unit Cupric Chloride Injection 250 EU / mg of copper Cupric Sulfate Injection 250 EU / mg of copper Cyanocobalamine Injection 0.4 EU / µg Cyclophosphamide for Injection 0.2 EU / mg Cyclosporine Injection 0.84 EU / mg (use 1:10 dilution; mix 0.1 ml with 0.1 ml LAL reagent on vortex mixer for 5 seconds) Cysteine Hydrochloride for Injection 0.7 EU / mg Cytarabine for Injection 0.07 EU / mg if labeled sterile or processed into injectable D Dacarbazine for Injection 0.52 EU / mg Dactinomycin for Injection 100 EU / mg Sodium 0.5 EU / mg Daunorubicin Hydrochloride for Injection 4.3 EU / mg of Daunorubicin Deferoxamine Mesylate for Injection 0.33 EU / mg if labeled sterile or processed into injectable Desmopressin Acetate 10 EU / µg Desoxycorticosterone Acetate 71.4 EU / mg Desoxycorticosterone Pivalate Suspension 2.78 EU / mg Acetate Injectable Suspension 21.7 EU / mg Dexamethasone Injection 21 EU / mg Dexamethasone Sodium Phosphate Injection 31.3 EU / mg Dextran 1 25 EU / g Dextran 40 in Dextrose Injection 1 EU / ml Dextran 40 in Sodium Chloride Injection 1 EU / ml Dextran 70 in Dextrose Injection 0.5 EU / ml Dextran 70 in Sodium Chloride Injection 0.5 EU / ml Dextrose (<5%) Injection 0.5 EU / ml for injections containing less than 5% of Dextrose Dextrose (5-70%) Injection 10 EU / g for injections containing less than 5% and 70% of Dextrose Dextrose and Sodium Chloride Injection 10 EU / g Diatrizoate Meglumine and Diatrizoate Sodium 34.3%-35% 1.8 EU / ml Diatrizoate Meglumine and Diatrizoate Sodium 28.5%-29.1% 1.8 EU / ml Diatrizoate Meglumine and Diatrizoate Sodium 50%-25% 1.8 EU / ml Diatrizoate Meglumine and Diatrizoate Sodium 52%-8% 1.8 EU / ml Diatrizoate Meglumine and Diatrizoate Sodium 60%-30% 3.6 EU / ml Diatrizoate Meglumine and Diatrizoate Sodium 66%-10% 3.6 EU / ml Diatrizoate Meglumine Injection <50% 1.1 EU / ml for injections containing less than 50% Diatrizoate Meglumine

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Description Endotoxin Limit Diatrizoate Meglumine Injection > or equal to 50% 5 EU / ml for injections containing less than 50% Diatrizoate Meglumine Diatrizoate Sodium 20% 5.6 EU / ml for injections containing 20% of Diatrizoate Sodium Diatrizoate Sodium 25% 1.3 EU / ml for injections containing 25% of Diatrizoate Sodium Diatrizoate Sodium 50% 5 EU / ml for injections containing 50% of Diatrizoate Sodium Injection 11.6 EU / mg Diazoxide Injection 0.5 EU / mg Dibucaine Hydrochloride Injection 35.7 EU / mg Dicyclomine Hydrochloridel Injection 17.2 EU / mg Diethylstilbestrol Injection 0.7 EU / mg Digitoxin Injection 111 EU / mg Digoxin Injection 200 EU / mg Dihydroergotamine Mesylate Injection 175 EU / mg Dihydrostreptomycin Injection 0.5 EU / mg Dimercaprol 1 EU / mg Dimethyl Sulfoxide Irrigation 0.5 EU / ml Dinoprost Tromethamine 8 EU / mg Diphenhydramine Hydrochloride Injection 3.4 EU / mg Dipyridamole Injection 8.8 EU / mg Dobutamine for Injection 5.56 EU / mg Dobutamine in Dextrose Injection 5.56 EU / mg Doputamine Docetaxel 0.3 EU / mg Dolasetron Mesylate Injection 2.7 EU / mg Dopamine Hydrochloride 16.67 EU / mg of Doputamine Hydrochloride Dopamine Hydrochloride in Dextrose 16.67 EU / mg Doxapram Hydrochloride Injection 3.3 EU / mg Doxorubicin Hydrochloride for Injection 2.2 EU / mg (from prepared 1.1 mg / ml DoxorubicinHydrochloride) Doxycycline for Injection 1.14 EU / mg Doxycycline Hyclate 1.14 EU / mg (See Doxycycline for Injection) 35.7 EU / mg Dyphylline Injection 0.7 EU / mg E Edetate Calcium Disodium Injection 0.01 EU / mg Edetate Disodium Injection 0.2 EU / mg Edrophonium Chloride Injection 8.33 EU / mg Electrolytes Multiple and Dextrose Type 1,2,3,4 0.5 EU / ml Electrolytes, Multiple, Type 1 & 2 0.5 EU / ml Emetine Hydrochloride 5.4 EU / mg Enalaprilat 280 EU / mg Enoxaparin Sodium Injection 0.01 unit Ephedrine Sulfate Injection 1.7 EU / mg Epinephrine Injection 357 EU / mg Epirubicin Hydrochloride 1.1 EU / mg Ergonovine Maleate Injection 700 EU / mg Ergotamine Tartrate Injection 357 EU / mg Erythromycin Gluceptate/Lactobionate 1 EU / mg Estradiol Injectable Suspension 250 EU / mg Estrone Injectable Suspension 88 EU / mg Ethacrynate Sodium 5 EU / mg Etoposide Injection 2 EU / mg (for a concentration of 0.31 mg Etoposide activity per ml)

Customer Service: US 800 638 8174, EU + 32 87 321 611 ; Scientific Support: US 800 521 0390, EU +32 87 321 611 5 Pharma&Biotech Updated as of August 2011. For reference use only. USP Endotoxin Limits This information is subject to the disclaimer included on page 13. for Common Injectables

Description Endotoxin Limit F Famotidine 16.67 EU / mg Fenoldopam Mesylate Injection 84 EU / mg Fentanyl Citrate 50 EU / mg Ferrous Citrate Fe59 Injection 50 EU / ml Ferumoxides Injection 12.5 EU / ml Fludarabine Phosphate for Injection 7.7 EU / mg Fludeoxyglucose F18 Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Flumazenil C11 Injection 100 EU / mg (175 / V EU / ml (V = max. total dose in ml at the expiration time)) Flunixin Meglumine Injection 4.54 EU / mg Fluorouracil Injection 0.33 EU / mg Fluphenazine Hydrochloride 166.67 EU / mg Folic Acid Injection 357.1 EU / mg Fructose 0.5 EU / ml Fructose and Sodium Chloride 0.5 EU / ml Furosemide Injection 3.6 EU / mg G Gadodiamide Injection 0.029 EU / mg Gadopentetate Dimeglumine Injection 25 EU / ml Gadoteridol Injection 8.3 EU / ml 5 EU / mg Gallium Citrate Ga67 Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Gentamicin Injection 0.71 EU / mg Glycine Irrigation 0.5 EU / ml Glycopyrrolate 555.5 EU / mg Gonadorelin Hydrochloride 3.6 EU / µg Guaifenesin for Injection 0.05 EU / mg H Haloperidol Injection 71.4 EU / mg Heparin Lock Flush Solution 0.5 EU / ml Heparin Sodium Injection 0.03 EU / USP Heparin Unit Phosphate Injection 125 EU / mg Hyaluronidase for Injection 2.3 EU / USP Hyalurondase Unit Hyaluronidase Injection 2.3 EU / USP Hyalurondase Unit Hydralazine Hydrochloride Injection 1.45 EU / mg Injectable Suspension 1.25 EU / mg Hydrocortisone Sodium Phosphate 1.25 EU / mg of Hydrocortisine Hydrocortisone Sodium Succinate 1.25 EU / mg of Hydrocortisine Hydromorphone Hydrochloride Injection 88 EU / mg Hydroxocobalamin 0.4 EU / µg Hydroxyzine Hydrochloride Injection 3.6 EU / mg Hyoscyamine Sulfate 714.3 EU / mg I Idarubicin Hydrochloride for Injection 8.9 EU / mg Idarubicin Hydrochloride solution at 0.07 mg / ml Ifosfamide for Injection 0.125 EU / mg Imipenem 0.17 EU / mg if labeled sterile Imipenem and Cilastatin for Injectable Suspension 0.23 EU / mg of Imipenem and 0.23 EU / mg Cilastatin Imipramine Hydrochloride Injection 5 EU / mg

Customer Service: US 800 638 8174, EU + 32 87 321 611 ; Scientific Support: US 800 521 0390, EU +32 87 321 611 6 Updated as of August 2011. For reference use only. This information is subject to the disclaimer included on page 13.

Description Endotoxin Limit Inamrinone Injection 0.5 EU / mg Indigotindisulfonate Sodium Injection 5 EU / mg Indium Chlorides In113m Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Indium In111 Capromab Pendetide Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Indium In111 Chloride Solution 175 / V EU / ml (V = max. total dose in ml at the expiration time) Indium In111 Pentetreotide Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Indium In111 Satumomab Pendetide Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Indium Pentetate In111 Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Indocyanine Green for Injection 7.1 EU / mg Indomethacin for Injection 20 EU / mg of Indomethacin at 1.0 mg / ml Insulin Human 10 EU / mg Insulin Human Injection 0.8 EU / unit Insulin Injection 0.8 EU / unit Insulin Isophane Suspension 0.8 EU / unit Insulin Lispro Injection 0.8 EU / unit Insulin Zinc Suspension (Ext. & Prompt) 0.8 EU / unit in Sodium Chloride Injection 0.1 EU / mg of Inulin Iodide Sodium I123 Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Iodide Sodium I125 Solution 175 / V EU / ml (V = max. total dose in ml at the expiration time) Iodide Sodium I131 Solution 175 / V EU / ml (V = max. total dose in ml at the expiration time) Iodipamide Meglumine Injection 3.6 EU / ml Iodixanol Injection 0.2 EU / 50mg of Iodine Iohexol Injection 0.2 EU / 50mg of Iodine Iophendylate Injection 0.6 EU / mg Iopromide Injection 1.25 EU / ml Iothalamate Meglumine and Iothalamate Sodium (66.8%) 3.35 EU / ml Iothalamate Meglumine and Iothalamate Sodium (52%-26%) 3.35 EU / ml Iothalamate Meglumine Injection (43%) 0.9 EU / ml Iothalamate Sodium Injection 3.35 EU / ml Ioversol Injection 1.4 EU / ml Ioxilan Injection 0.2 EU / 50mg of Iodine Iron Dextran Injection 0.5 EU / mg of Iron Iron Sorbitex 10 EU / ml Iron Sucrose Injection 3.7 EU / mg of Iron Acetate Injecion Suspension 125 EU / mg of Isoflupredone Acetate Isoniazid 0.3 EU / mg of Isoniazid Isoproterenol Hydrochloride Injection 1250 EU / mg of Isoproterenol Hydrochloride Isoxsuprine Hydrochloride Injection 35.7 EU / mg K Kanamycin Injection 0.67 EU / mg Hydrochloride 0.4 EU / mg Ketorolac Tromethamine Injection 5.8 EU / mg Labetalol Hydrochloride 1.2 EU / mg Leucovorin Calcium Injection 1.95 EU / mg Leuprolide Acetate 166.7 EU / mg Levocarnitine Injection 0.1 EU / mg Levorphanol Tartrate Injection 125 EU / mg Lidocaine Hydrochloride and Dextrose Injection 1.1 EU / mg of Lidocaine Hydrochloride Lidocaine Hydrochloride and Epinephrine Injection 0.7 EU / mg of Lidocaine Hydrochloride Lidocaine Hydrochloride Injection 1.1 EU / mg

Customer Service: US 800 638 8174, EU + 32 87 321 611 ; Scientific Support: US 800 521 0390, EU +32 87 321 611 7 Pharma&Biotech Updated as of August 2011. For reference use only. USP Endotoxin Limits This information is subject to the disclaimer included on page 13. for Common Injectables

Description Endotoxin Limit Lincomycin Injection 0.5 EU / mg of Lincomycin 100 EU / mg M 0.09 EU / mg Magnesium Sulfate in Dextrose Injection 0.039 EU / mg Mangafodipir Trisodium 0.66 EU / mg Manganese Chloride Injection 0.45 EU / µg of Manganese Manganese Sulfate Injection 0.45 EU / µg of Manganese Mannitol in Sodium Chloride Injection 0.04 EU / mg of Manitol Mannitol Injection (< = 10%) 0.04 EU / mg for injections containing 10% or less Manitol Mannitol Injection (> 10%) 2.5 EU / g for injections containing greater than 10% Manitol Mechlorethamine Hydrochloride for Injection 12.5 EU / mg Menadiol Sodium Diphosphate (K-4) 25 EU / mg Menadione 58.3 EU / mg Menotropins for Injection 2.5 USP Follicle Stimulating Hormone Unit Meperidine Hydrochloride Injection 2.4 EU / mg Mepivacaine Hydrochloride and Levonordefrin Injection 0.8 EU / mg of Mepivacaine Hydrochloride Mepivacaine Hydrochloride Injection 0.8 EU / mg Meropenem for Injection 0.125 EU / mg Mesoridazine Besylate Injection 7 EU / mg Metaraminol Bitartrate 3.5 EU / mg Hydrochloride 8.8 EU / mg Injection 0.2 EU / mg Methohexital Sodium 0.5 EU / mg Methotrexate Sodium Injection 0.4 EU / mg Methotrimerprazine 17.9 EU / mg Methyldopate Hydrochloride 0.5 EU / mg Injection 2.5 EU / ml Methylergonovine Maleate 1.7 EU / µg Sodium Succinate Injection 0.17 EU / mg of Methylprednisolone Metoclopramide 2.5 EU / mg Metoprolol Tartrate 25 EU / mg Metronidazole Hydrochloride 0.35 EU / mg Mezlocillin for Injection 0.06 EU / mg of Mezlocillin Injection 0.1 EU / mg Midazolam Hydrochloride 8.33 EU / mg Minocycline for Injection 1.25 EU / mg Mitomycin for Injection 10 EU / mg Mitoxantrone Injection 5 EU / mg Morphine Sulfate Injection 17 EU / mg for Parenterals N Nafcillin Injection 0.13 EU / mg Nalorphine Hydrochloride 11.6 EU / mg Naloxone Hydrochloride Injection 500 EU / mg Neomycin for Injection 1.3 EU / mg Netilmicin 1.25 EU / mg Niacin 3.5 EU / mg Niacinamide Injection 3.5 EU / mg Nitroglycerin 0.1 EU / µg

Customer Service: US 800 638 8174, EU + 32 87 321 611 ; Scientific Support: US 800 521 0390, EU +32 87 321 611 8 Updated as of August 2011. For reference use only. This information is subject to the disclaimer included on page 13.

Description Endotoxin Limit Norepinephrine Bitartrate Injection 83.4 EU / mg of Norepinephrine O Ondansetron Injection 9.9 EU / mg Citrate Injection 5.8 EU / mg Oxacillin for Injection 0.2 EU / mg Oxymorphone Hydrochloride 238.1 EU / mg Oxytetracycline for Injection 0.4 EU / mg Oxytocin Injection 35.7 unit P Paclitaxel 0.4 EU / mg Paclitaxel Injection 0.67 EU / mg Papaverine Hydrochloride 2.9 EU / mg Pen G Proc, D-Streptomycin, 0.0001 unit Pen G Proc, D-Streptomycin,Dexamethasone 0.0001 unit Penicillin G Benzathine Suspension 0.0001 unit Penicillin G Potassium for Injection 0.0001 unit Penicillin G Procaine Suspension (all) 0.0001 unit Penicillin G Sodium for Injection 0.0001 unit Pentazocine Injection 5.8 EU / mg Sodium Injection 0.8 EU / mg Perflutren Protein-Type A Micro. Injection 0.5 EU / ml Perphenazine 35.7 EU / mg Phenobarbital Sodium for Injection 0.3 EU / mg Phenylbutazone Injection 1.1 EU / mg Phenylephrine Hydrochloride Injection 25 EU / mg Phenytoin Sodium Injection 0.3 EU / mg Physostigmine Salicylate 83.4 EU / mg Phytonadione Injection 14 EU / mg Piperacillin for Injection 0.07 EU / mg if sterile or processed into injectable Plicamycin for Injection 100 EU / mg Potassium Acetate Injection 8.8 mEq Potassium Chloride for Injection 8.8 mEq Potassium Phosphate Injection 1.1 EU / mg Pralidoxine Chloride for Injection 0.1 EU / mg if sterile or processed into injectable Prednisolone Sodium Phosphate Injection 5 EU / mg Prednisolone Sodium Succinate Injection 5.8 EU / mg of Prednisolone Prednisolone Tebutate Suspension 8.8 EU / mg Injectable Suspension 2.27 EU / mg Prilocaine Hydrochloride 0.9 EU / mg Prilocaine Hydrochloride and Epinephrine 0.9 EU / mg Procainamide Hydrochloride Injection 0.35 EU / mg Procaine Hydrochloride 0.6 EU / mg if labeled sterile or processed into injectable Procaine Hydrochloride and Epinephrine 0.6 EU / mg Procaine, Tetracaine and Levonordefrin Injection 0.6 EU / mg Prochlorperazine Edisylate Injection 17.9 EU / mg Hydrochloride Injection 1.8 EU / mg Prompt Insulin Zinc Suspension 0.8 unit Propofol 0.33 EU / mg Propoxycaine, Procaine Hydrochloride and Norepinephrine Bitartrate 0.8 EU / mg of Propoxycaine Hydrochloride

Customer Service: US 800 638 8174, EU + 32 87 321 611 ; Scientific Support: US 800 521 0390, EU +32 87 321 611 9 Pharma&Biotech Updated as of August 2011. For reference use only. USP Endotoxin Limits This information is subject to the disclaimer included on page 13. for Common Injectables

Description Endotoxin Limit Propoxycaine, Procaine Hydrochloride and Levonordefrin 0.8 EU / mg of Propoxycaine Hydrochloride Propranolol Hydrochloride Injection 55.6 EU / mg Protamine Sulfate Injection 7 EU / mg Protein Hydrolysate Injection 0.5 EU / mg Pyridostigmine Bromide Injection 17 EU / mg Pyridoxine Hydrochloride 0.4 EU / mg Q Quinidine Gluconate Injection 0.6 EU / mg R Ranitidine Injection 7 EU / mg Reserpine Injection 71.5 EU / mg Riboflavin Injection 7.1 EU / mg Rifampin for Injection 0.5 EU / mg Ringer's - Lactated in Dextrose 0.5 EU / ml Ringer's - Lactated Injection 0.5 EU / ml Ringer's in Dextrose 0.5 EU / ml Ringer's Injection 0.5 EU / ml Ringer's Irrigation 0.5 EU / ml Ritodrine Hydrochloride Injection 0.5 EU / mg Rubidium Chloride Rb82 Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) S Samarium Sm 153 Lexidronam Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Sargramostim for Injection 50 EU / mg Scopolamine HBr Injection 555 EU / mg Secobarbital Sodium Injection 0.9 EU / mg if labeled sterile or processed into injectable Selenious Acid (Selenium) 3.5 EU / µg Sincalide for Injection 83.3 EU / µg Sisomicin Sulfate 0.5 EU / mg Sodium Acetate Injection 3.9 mEq Sodium Bicarbonate 5 mEq Sodium Chloride Injection (0.45-0.9%) 0.5 EU / ml (labeled amount of sodium chloride is 0.5% - 0.9%) Sodium Chloride Injection (3- 24.3%) 3.6 EU / ml (labeled amount of sodium chloride is 3.0% - 24.3%) Sodium Chloride Irrigation 0.5 EU / mg Sodium Chromate Cr51 Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Sodium Fluoride F18 Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Sodium Iodide I123 Solution 175 / V EU / ml (V = max. total dose in ml at the expiration time) Sodium Iodide I131 Solution 175 / V EU / ml (V = max. total dose in ml at the expiration time) Sodium Lactate Injection 2 mEq Sodium Nitoprusside for Injection 0.05 EU / µg if labeled sterile or processed into injectable Sodium Nitrite Injection 0.33 EU / mg Sodium Phosphate Injection 1.1 EU / mg Sodium Phosphate P32 Solution 175 / V EU / ml (V = max. total dose in ml at the expiration time) Sodium Thiosulfate 0.03 EU / mg Somtropin for Injection 20 EU / mg Spectinomycin Hydrochloride 0.09 EU / mg of Spectinomycin if labeled sterile or processed into injectable Sterile Vancomycin Hydrochloride 0.33 EU / mg of Vancomycin Streptomycin Injection 0.25 EU / mg Strontium Chloride Sr89 Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Succinylcholine Chloride for Injection 2 EU / mg if labeled sterile or processed into injectable

Customer Service: US 800 638 8174, EU + 32 87 321 611 ; Scientific Support: US 800 521 0390, EU +32 87 321 611 10 Updated as of August 2011. For reference use only. This information is subject to the disclaimer included on page 13.

Description Endotoxin Limit Sufentanil Citrate 6.25 EU / mg Sulbactam Sodium 0.17 EU / mg of Sulbactum if labeled sterile of processed into injectable Sulfadiazine Sodium 0.1 EU / mg T Technetium Tc99m (Pyro, trimeta) Phosph 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Albumin Aggregated Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Apcitide Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Arcitumomab Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Bicisate Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Depreotide Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Disofenin 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Etidronate 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Exametazime Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Gluceptate 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Lidofenin 175 / V EU / ml (V = max. total dose in ml at the expiration time) TechnetiumTc99m Medronate 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Mertiatide Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Nofetumomab Merpentan Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Oxidronate 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Pentetate Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Pyrophosphate 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Red Blood Cells Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Sestamibi Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Sodium Pertechnetate 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Succimer 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Sulfur Colloid 175 / V EU / ml (V = max. total dose in ml at the expiration time) Technetium Tc99m Tetrofosmin Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Terbutaline Sulfate Injection 1,250 EU / mg Testosterone Injectable Suspension 3.5 EU / mg Tetracaine Hydrochloride and Dextrose (Intrathecal) 1 EU / mg Tetracaine Hydrochloride (Intrathecal) 0.7 EU / mg Tetracycline Hydrochloride 0.5 EU / mg if labeled sterile or processed into injectable Thallus Chloride Tl201 Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Theophylline in Dextrose Injection 1 EU / mg Thiamine Hydrochloride 3.5 EU / mg Thiamylal Sodium 1 EU / mg Thiopental Sodium for Injection 1 EU / mg Thiotepa for Injection 6.25 EU / mg Thiothixene Hydrochloride for Injection 88 EU / mg Ticarcillin Disodium and Clavulanate 0.07 EU / mg Ticarcillin for Injection 0.05 EU / mg Tiletamine and Zolazepam for Injection 0.07 EU / mg of combined Tiletamine and Zolazepam Tilmicosin Injection 0.5 EU / mg Tobramycin for Injection 2 EU / mg Tobramycin Inhalation Solution 60 EU / ml Tolazoline Hydrochloride Injection 0.8 EU / mg for Injection 0.35 EU / mg Acetonide Injection Suspension 4.4 EU / mg Injection Suspension 7.1 EU / mg Triamcinolone Hexacetonide Suspension 17.2 EU / mg

Customer Service: US 800 638 8174, EU + 32 87 321 611 ; Scientific Support: US 800 521 0390, EU +32 87 321 611 11 Pharma&Biotech Updated as of August 2011. For reference use only. USP Endotoxin Limits This information is subject to the disclaimer included on page 13. for Common Injectables

Description Endotoxin Limit Trifluoperazine Hydrochloride Injection 172 EU / mg Triflupromazine Hydrochloride Injection 5.8 EU / mg Trimethobenzamide Hydrochloride 1.8 EU / mg Tripelennamine Hydrochloride Injection 4.6 EU / mg Tromethamine 0.03 EU / mg Injection 10 EU / mg U Urea for Injection 0.003 EU / mg V Valrubicin Intravesical Injection 0.14 EU / mg of Valrubicin Vancomycin Injection 0.33 EU / mg Vasopressin Injection 17 EU / Vasopressin Unit 10 EU / mg Verapamil Hydrochloride 16.7 EU / mg of Valrubicin Vidarabine for Injection 0.5 EU / mg except when used in opthalmic dosage Vinblastine Sulfate for Injection 10 EU / mg Vincristine Sulfate for Injection 100 EU / mg Vincristine Sulfate Injection 62.5 EU / mg W Warfarin Sodium for Injection 24 EU / mg Water for Inhalation (Sterile) 0.5 EU / ml Water for Injection and Sterile WFI 0.25 EU / ml Water for Irrigation (Sterile) 0.25 EU / ml Water 15O Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) X Xe133 Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Xylazine Injection 1.7 EU / ml Y Yohimbine Injection 45.5 EU / mg Yttrium Y 90 Ibritumomab Tiuxetan Injection 175 / V EU / ml (V = max. total dose in ml at the expiration time) Z Zidovudine Injection 1 EU / mg Zinc Chloride Injection 25 EU / mg Zn Zinc Sulfate Injection 25 EU / mg Zn Zolazepam Hydrochloride 0.07 EU / mg Zolazepam

Customer Service: US 800 638 8174, EU + 32 87 321 611 ; Scientific Support: US 800 521 0390, EU +32 87 321 611 12 www.lonza.com/lal

Contact Information North America Customer Service: 800 638 8174 (toll free) [email protected] Scientific Support: 800 521 0390 (toll free) [email protected]

Europe Customer Service: +32 87 321 611 [email protected] Scientific Support: +32 87 321 611 [email protected]

International Contact your local Lonza distributor Customer Service: +1 301 898 7025 [email protected]

Lonza Walkersville, Inc. — Walkersville, MD 21793

Updated as of August 2011. For reference use only. Unless otherwise noted, all trademarks herein are marks of the Lonza Group or its affiliates.

The information contained herein is believed to be correct and corresponds to the state of scientific and technical knowledge as of the date set forth above. However, no warranty is made, either expressed or implied, regarding its accuracy or the results to be obtained from the use of such information and no warranty is expressed or implied concerning the use of this information. The user assumes all risks of use. Any user must make his own determination and satisfy himself that the information supplied by Lonza and any recommendations given by Lonza are (i) suitable for intended process or purpose and (ii) in compliance with environmental, health and safety regulations. No statement is intended or should be construed as a recommendation to infringe any existing patent.

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