Audit # JA - 853
Region United States
Standards Excipient /API
Company Avantor Performance Matierals
Location 7001 Martin Luther King Blvd Paris KY 40362
Date October 3-4 2017
Materials Excipient: Citric Acid, Monohydrate, Granular, USP, EP, BP, JP Edetate Disodium, USP,EP, JP (Excipient) Excipient 8995 Ethyl hydroxybenzoate Excipient 6882-18 L-Arginine Hydrochloride, USP, EP, JP (Excipient) Excipient 2067 L –Arginine, USP, EP (Excipient) Excipient 2066 L- Methionine USP, EP, JP (Excipient) Excipient 2085 Magnesium Stearate Mannitol,Powder, USP, EP, JP (Excipient) Excipient 2553 Methylparaben, Methylhydroxybenzoate Excipient 6215-18 Potassium Chloride Propylhydroxybenzoate Excipient 7624- SODIUM HYDROXIDE, Pellet NF SODIUM CITRATE DIHYDRATE USP (Multicompendial Sodium Hydroxide (7680-28) ) Basic Chemicals/Raw Materials: Acetone, NF, EP Raw Materials 9036-XX Calcium Chloride, Dihydrate, Granular USP, EP, JP Raw Materials 1335 Calcium D - (+) Pantothenate , USP Raw Materials 1443-08 Citric Acid, Monohydrate, Granular, USP Raw Materials 616 Cupric Sulfate 5-Hydrate USP, EP (Copper (II) Sulfate, Pentahydrate Raw Materials 1846-07 Ferrous Sulfate, 7 Hydrate,- Crystal; USP,EP,JP (Iron (II) Sulfate, Heptahydrate) Raw Materials 2063-05(2.5kg) Glycerin (Glycerol), USP, EP, JP Raw Materials 2143-07 (19L) Glycine, USP, EP, JP Raw Materials 582 Glycine, USP,EP,JP (Excipient) Excipient 582 Guanidine Hydrochloride, GenAR® Raw Materials 0507-XX L-Arginine Hydrochloride, USP, EP, JP USP, EP, JP Raw Materials 2067 Magnesium Sulfate, Anhydrous Powder USP Raw Materials 5053 Magnesium Sulfate, 7-Hydrate, Crystal, USP, EP Crystal Raw Materials 2504 Niacin U.S.P - F.C.C. Raw Materials 2745-01 (500g's) SODIUM HYDROXIDE SOLUTION, 10N:5000-XX API: (Avantor does not consider these materials APIs.) EDTA Editate Disodium Zinc Sulfate Heptahydrate, USP (8872) (API)

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