Customization: | Available |
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Powder: | Yes |
Customized: | Customized |
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Product Name | Vitamin E<all-rac-α-Tocophery Acetate> | ||
Batch No. | AR20201028 | Specifications | Raw Material |
Sample Source | Plant 156 | Package | Drum |
Mfg Date | 2020/10/28 | Quantity | 1000.0kg |
Retest Date | 2023/10/27 | Test Standard | Ph.Eur/USP/FCC |
ITEMS | METHODS | SPECIFICATIONS | RESULTS |
Description | Visual | Clear, colourless slightly greenish-yellow, Viscous, oily liquid, Ph.Eu/USP/FCC |
Clear, slightly greenish-yellow, Viscous, oily liquid |
Identification | |||
Optical rotation | Ph.Eur:2.2.7 | 0.010 -+0.01,Ph Eur. | 0.00 |
IR | Ph.Eur2.2.24 | To conform, Ph.Eu:/USPFCC | Conform |
Color reaction | USP | To conform, USP/FCC | Conform |
Retention time | GC | To conform, USP/FCC | Conform |
Related Substances | |||
Impurity A | Ph.Eur2.2.28 | ≤0.5% Ph.Eur. | <0.1% |
Impurity B | Ph.Eur2.2.28 | ≤1.5%, Ph.Eur. | 0.66% |
Impurity C | Ph.Eur2.2.28 | ≤0.5%, Ph.Eur. | 0.10% |
Impurities D and E | Ph.Eur2.2.28 | ≤1.0%,Ph.Eur. | <0.1% |
Any other impurity | Ph.Eur2.2.28 | ≤0.25%, Ph.Eur. | <0.1% |
Total impurities | Ph.Eur2.2.28 | ≤2.5%, Ph.Eur. | 0.75% |
Acidity | USP/FCC | ≤1.0ml, USP FCC | 0.07mL |
Residual Solvents | Ph.Eur:2.4.24 USP<467> | To conform (In-house) | Conform |
Heavy metals | |||
Pb | AA | ≤2mg/kg, FCC | <0.5mg/kg |
Arsenic | ChP0822 | ≤1mg(in-house) | <1mg/kg |
Copper | ICP-MS | ≤25mgkg in-house) | <2mg/kg |
zinc | ICP-MS | ≤25mg/kg in-house) | <2m/kg |
Palladium | AA | ≤5ppm(n house) | <1ppm |
Assay | |||
Assay(Ph.Eur) | Ph.Bur.2.2.28 | 96.5%~ 102.0%, Ph.Eur. | 99.1% |
Assay(Ph.Eur.) | Ph.Eur2.2.28 | 434.3mg a-tocopherol/g 459.0mg alocopheroVg Ph.Eur. | 446.0m g a-tocopherol/g |
Assay(USP/FCC) | Ph.Eur.2.2.28 | 96.0%- 102.0%.USPFCC | 99.1% |
Assay(USP/FCC) | Ph.Eur:2.2.28 | 432.0mg. a-tocopherol/g 459.0mg a-tocopherol/g, USP/FCC |
446.0m g a-tocopherol/g Certified |
Microbial limit | |||
TAMC | USP<61> Ph.Eur2.6.12 | ≤1000ciug, Ph.Eur/USP | Certified |
TYMC | USP<61> Ph.Eur2.6.12 | ≤100cfu/g, Ph.Eur/USP | Certified |
Escherichia coli | USP<62> Ph.Eur2.6.13 | n.d/g. PhEu/USP | Certified |
Pseudomonas aeruginosa | USP<62> Ph.Eur.2.6.13 | n.d/. Ph.Eur:/USP | Certified |
Staphylococcus aureus | USP<62> Ph.Eur.2.6.13 | nd/gPh.Eu/USP | Certified |
Enterobacterial | USP<62>Ph.Eur.2.6.13 | nd/g, P.Eur:/USP | Certified |
Salmonella | USP<62> Ph.Eur.2.6.13 | nd./10g, Ph.Eur/USP | Certified |