Audit Reports
To initiate a report purchase, simply select the Report Number which corresponds to your report selection and add it in the Report box on the Audit Report Form. Now available for purchase: Reports offered through the IPEA Excipient GMP Certification program, see below for listing.
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Available Certification Audit Reports |
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| Certification Report cost: IPEC-Americas Members: $500 Non-Members: $750 | ||||
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Report Number
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Excipient Chemical/
Compendia Name |
Manufacturer
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Location
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Excipient Trade Name
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Silicon Dioxide NF
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Grace Davison
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Curtis Bay, Baltimore
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SyloidR 63 FP, 72 FP, and 244 FP
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Silicon Dioxide NF
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Grace Davison
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Sorocaba, Brazil
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SyloidR 63 FP, and 244 FP
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| 0003 | Isopropyl Alcohol, Hexylene Glycol | Johann Haltermann, Ltd | Houston, TX | Isopropyl Alcohol, Anhydrous Hexylene Glycol |
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Propylene Glycol USP, Dipropylene Glycol
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The Dow Chemical Company
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Freeport, Texas
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PuraGuard* Propylene Glycol USP/EP
Dipropylene Glycol LO+ |
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Propylene Glycol USP, Dipropylene Glycol
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The Dow Chemical Company
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Plaquemine, Louisiana
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PuraGuard* Propylene Glycol USP/EP
Dipropylene Glycol LO+ |
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| Available Audit Reports | ||||
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Audit Program Report cost: IPEC-Americas Members: $1,000 Non-Members: $1,500
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Report Number
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Excipient Chemical/
Compendia Name |
Manufacturer
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Location
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Excipient Trade Name
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Aspartame NF, Aspartame-Acesulfame Salt
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The Nutrasweet Company
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Augusta, GA
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NutraSweet, TwinSweet
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Magnesium Oxide, USP, Magnesium Hydroxide USP, and Magnesium Carbonate, USP
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Dead Sea Periclase
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Mishor Rotem, Israel
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Magnesium Oxide (DC, HA, HA4, USP Light) Magnesium Hydroxide (HP5, 7,9, and 12) Magnesium Carbonate (only one grade)
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Potassium Chloride, USP
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Dead Sea Works
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Sdom Israel
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Potassium Chloride, USP
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Cellulose Acetate 320S-NF/EP
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Eastman Chemical Company
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Kingsport, Tennessee
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EastmanTM CA-320S NF/EP
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Cellulose Acetate 398-10 NF/EP
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Eastman Chemical Company
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Kingsport, Tennessee
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EastmanTM CA-398-10 NF/EP
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Cellulose Acetate Butyrate-171-15 NF
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Eastman Chemical Company
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Kingsport, Tennessee
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EastmanTM CAB-171-15 NF
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Cellulose Acetate Phthalate NF
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Eastman Chemical Company
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Kingsport, Tennessee
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EastmanTM CAP NF
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| MNG-07 | Microcrystalline Cellulose | Mingtai Chemical Co. | Taoyuan Hsien, Taiwan | Comprecel |
| MNG-08 | Croscarmellose Sodium | Mingtai Chemical Co. | Taoyuan Hsien, Taiwan | Disolcel |
| MNG-09 | Microcrystalline Cellulose & Carboxymethylcellulose Sodium | Mingtai Chemical Co. | Taoyuan Hsien, Taiwan | Neocel |
| YZ-01 | Starch Carboxymethyl ether, sodium salt. DST (Sodium starch glycolate) |
Yung Zip Chemical Industrial Co Ltd |
Taichung, Taiwan | DST (Sodium Starch Glycolate) |
| Expired Reports | ||||
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Expired
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Excipient Chemical/
Compendia Name |
Manufacturer
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Location
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Excipient Trade Name
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| Expired | Povidone, USP | ISP Chemicals, LLC | Calvert City, KY | Plasdone K-90 |
| Expired | Crospovidone NF | ISP Chemicals, LLC | Calvert City, KY | Polyplasdone |
| Expired |
Crospovidone NF
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ISP Technology Inc.
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Texas City, TX
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Polyplasdone
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| Expired |
Copovidone NF
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ISP Technology Inc.
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Texas City, TX
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Plasdone S-630
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| Expired |
Povidone, USP
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ISP Technology Inc.
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Texas City, TX
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Plasdone C and K grades
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| Expired |
Pharmasolve
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ISP Technology Inc.
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Texas City, TX
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NMP
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| Expired | Audit for the Manufacture of Excipient Grade Acids | Columbus Chemical Industries Inc. | Columbus, WI | Hydrochloric Acid, Nitric Acid |
| Expired | Assessment of Overall Capabilities for the Manufacture of Excipient Grade Solvents | Tedia Company Inc. | Fairfield, Ohio | Several Grades including ACS & HPLC/ Spectroscopic |
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Expired
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Microcrystalline Cellulose & Carboxymethylcellulose Sodium
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Mingtai Chemical Co.
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Taoyuan Hsien, Taiwan
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Neocel
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Expired
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Croscarmellose Sodium
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Mingtai Chemical Co.
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Taoyuan Hsien, Taiwan
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Disolcel
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Expired
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Microcrystalline Cellulose
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Mingtai Chemical Co.
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Taoyuan Hsien, Taiwan
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Comprecel
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Expired
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FD&C Yellow #5, Eurocet Sunset Yellow FCF E110 ( FD&C Yellow #6), Blue #1 Aluminum Lake
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Sensient Colors, Inc.
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St. Louis, MO
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Food Colors
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Expired
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Cellulose Acetate Phthalate NF
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Eastman Chemical Company
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Kingsport, Tennessee
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EastmanTM CAP NF
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Expired
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Cellulose Acetate 398-10 NF/EP
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Eastman Chemical Company
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Kingsport, Tennessee
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EastmanTM CA-398-10 NF/EP
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Expired
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Cellulose Acetate 320S-NF/EP
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Eastman Chemical Company
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Kingsport, Tennessee
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EastmanTM CA-320S NF/EP
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Expired
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Cellulose Acetate Butyrate-171-15 NF
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Eastman Chemical Company
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Kingsport, Tennessee
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EastmanTM CAB-171-15 NF
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Expired
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Various excipients sold under BDH Aristar
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VWR International
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West Chester, PA
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BDH Aristar
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Expired
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Silicon Dioxide
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Grace Davison
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Curtis Bay, Baltimore
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Syloid/Sylodent
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Expired
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Silicon Dioxide
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Grace Davison
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Sorocaba, Brazil
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Syloid
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Expired
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Sodium Fluoride
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Sunlit Fluo & Chemical Co.
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Taipei, Taiwan
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Sodium Fluoride
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Expired
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Xanthan Gum NF
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CP Kelco
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Oklahoma, USA
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Xantural 180
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Expired
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Alcohol, USP
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Equistar
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Illinois, USA
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Ethyl Alcohol
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Expired
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Alcohol, USP: Denaturing&Packaging
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Equistar
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New Jersey, USA
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Denaturing & Packaging
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Expired
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Carrageenan NF
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USA
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USA
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USA
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Expired
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Hydroxypropylated Starch NF
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USA
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USA
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USA
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Expired
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Magnesium Silicate NF
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USA
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USA
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USA
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Expired
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N-Methyl Pyrrolidone
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International Specialty Products Technologies
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Texas City, TX
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Pharmasolve, Pharmasolve V
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Expired
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Polyvinylpyrrolidone
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International Specialty Products Technologies |
Texas City, TX
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Plasdone C15, C30, K17, K25, K29/32
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Expired
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Polyvinylpyrrolidone (PVP)/Vinyl Acetate (VA)
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International Specialty Products Technologies |
Texas City, TX
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Plasdone S630
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Expired
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Disodium Succinate Hexahydrate
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Nippon Shokbai
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Himeji, Japan
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SS-50
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Expired
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Sulfuric Acid NF
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Productos Quimicos
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Neuvo Leon, Mexico
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Sulfuric Acid
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Expired
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Disodium Succinate Hydrate
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Shivam Enterprises
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Pune, India
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Sodium Succinate Hydrate
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Expired
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Sodium Hydroxide NF
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Canton Laboratories
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Vadodara, India
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Sodium Hydroxide
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Expired
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Povidone
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International Specialty Products
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Calvert City, KY
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Plasdone
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Expired
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Crospovidone
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International Specialty Products
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Calvert City, KY
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Polyplasdone
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Expired
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FMC Biopolymer
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Warehouse Audit
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Mechanicsburg, PA
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N/A
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Expired
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Chromatographic products
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Grace Davison
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Hesperia, CA
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Silicas & columns
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