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. A full listing of (expired) audits performed by IPEA is available at ipeainc.com/Audit_Report_Archive.
Reports offered through the IPEA Excipient GMP Certification program are also available for purchase, see below for listing
Excipient GMP Conformance Certification Audit Reports
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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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| 0007 | Propylene Glycol USP | Huntsman Performance Products | Port Neches, TX | PGUSP |
Audit Program ReportsIPEC-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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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) |
