| Audit # | JA - 798 |
|---|---|
| Region | Spain |
| Standards | Basic Chemicals/Raw Materials/API and Excipient |
| Company | Merck KGaA (MilliporeSigma in N.A.) |
| Location | Barcelona, Spain |
| Date | March 6-7-2017 |
| Materials | Basic Chemicals/Raw Materials: Sodium edetat dihydrate API: Meglumine Excipient: Tris(Hydroxymethyl)aminomethane (TROMETAMOL) high purity suitable for biopharmaceutical production EMPROVE® bio Ph Eur,BP,JPC,USP,ACS. (art. 1.08307) Tris(hydroxymethyl)aminomethane (Trometamol) suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,USP (art. 1.08386) Titriplex® III (ethylenedinitrilotetraacetic acid disodium salt dihydrate) suitable for use as excipient EMPROVE® exp Ph Eur, BP, JP, USP. (1.08421) TITRIPLEX III (Ethylene diaminetetraacetic Acid (EDTA), Disodium Salt, Dihydrate) suitable for the biopharmaceutical production EMPROVE® bio Ph Eur, BP, JP, USP, ACS. (1.37004) Active cosmetic ingredients also treated as atypical APIs: Eusolex® OCR (Octocrylene) Eusolex® 9020 (Butyl Methoxydibenzoylmethane) |
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