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Vit E Asetat
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Certificate of Analysis
Product name: all-rac- α -tocopheryl acetate Number of analysis: T0002346 Batch number / Volume: 15G14-H06-00187 / 100ml Producer Batch Number: UT15010025 Analysed according to: PH.EUR 8.2 Tests Requirement Result Unit Standard remark Appearance Clear, colourless or slightly greenish-yellow, viscous, oily liquid Conform Identification A -0,01 - +0,01 0,0 ° 10% m/V Identification B Conform Conform IR-spectrum Related substances Conform Conform GC; DP Impurity A <= 0,5 0,1 % Impurity C <= 0,5 0,1 % Impurity B <= 1,5 0,6 % Sum of impurities D and E <= 1,0 0,4 % Any other impurity <= 0,25 0,12 % Total impurities <= 2,5 1,8 % Residual solvents CPMP/ICH/283/95 Conform DP Assay alfa-Tocopherol acetate 96,5 - 102,0 99,1 %m/m GC
Analysis performed by the authorized internal lab. Release: Vasileios Dimitroulis Pharmacist - QA Manager / QP
16/07/2015 Expiration: 10-01-2019 Conclusion: APPROVED This document has been produced electronically from our quality system and is valid without signature.