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8.3.2.2.2. Excipients
All excipients used in the manufacture of emtricitabine/tenofovir DF tablets are commonly used and meet the standards defined in the current United States Pharmacopoeia (USP) or United States National Formulary (NF) monographs except for the film-coating material, Opadry II Light Blue Y-30-10671-A, which is tested according to in-house standards. All ingredients of Opadry II Light Blue Y-30-10671-A, except FD&C Blue #2 aluminum lake, are of USP/NF quality. FD&C Blue #2 aluminum lake conforms to 21 CFR 74.102. The appropriate testing to meet the
acceptance criteria of each monograph will be performed on each lot of excipient.
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