Oxynex® LM, EMPROVE® ESSENTIAL antioxydant pour graisses et huiles, pouvant être utilisé comme excipient, SAFC®
Marques : MERCK PRODUCTION CHEMICALSTotal Evaluation: 0
Moyenne des Notes : 0.0 sur 5
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Attention
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Résultats des tests de spécification
DL-α-Tocopherol (vitamin E) E 307 (HPLC) | 24.0 - 27.0 % |
6-Palmitoyl-L-ascorbic acid (ascorbyl palmitate) E 304 (HPLC) | 18.0 - 22.0 % |
Identity | IR spectrum conforms |
Al (Aluminium) | ≤ 50 ppm |
Ni (Nickel)* | ≤ 2 ppm |
Sulfated ash | ≤ 2.5 % |
Colony count (aerobic bacteria) | ≤ 100 CFU/g |
Colony count (Yeasts and moulds) | ≤ 100 CFU/g |
E.coli | absent in 1 g |
Pseudomonas aeruginosa | absent in 1 g |
Staphylococcus aureus | absent in 1 g |
Candida albicans | absent in 1 g |
Salmonella species | absent in 10 g |
citric acid (calculated from weighing protocol) | 2.4 - 2.6 % |
Lecithin E 322 (calculated from weighing protocol) | 24 - 25 % |
Mono- and diglycerides of edible fatty acids E 471 (calculated from weighing protocol) | 26 - 27 % |
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). |
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