D-alpha-Tocopheryl acetate
Quick Details
Quick Details
Other Names:D-alpha-Tocopheryl acetate
MF:C31H52O3
EINECS No.:231-710-0
Type:Vitamins, Amino Acids and Coenzymes
Grade Standard:Medicine Grade
Usage:Animal Pharmaceuticals
Model Number:TOP
Purity:99%
Product Name:D-alpha-Tocopheryl acetate
MW:472.74
Color:yellow
Form:liquid
Shelf life:2 Years
Melting point:~25 °C(lit.)
alpha:3 °(c=2, in ethanol 25 °C)
Boiling point:224 °C0.3 mm Hg(lit.)
Density:0.953 g/mL at 25 °C(lit.)
refractive index:n20/D 1.496(lit.)
Product Description
D-alpha-Tocopheryl acetate
Vitamine E-acetate
CAS NO: 58-95-7
Molecular Formula:C31H52O3
Molecular Weight:472.75 D-alpha-Tocopheryl acetate
Vitamine E-acetate
CAS NO: 58-95-7
Molecular Formula:C31H52O3
Appearance: clear, pale yellow, viscous oil
Certification of Analysis
Test items Specifications Results
Appearance pale yellow liquid Qualified
Identification Positive Qualified
Dispersibility in water Dispersible Qualified
Content Min.50% of vitamin E 52.50%
Loss on Drying <3.0% 1.30%
Granularity 100% through 40# sieve 100%
Min.90% through 60# sieve 98.00%
Min.45% through 100# sieve 80.00%
Heavy Metal ≤10ppm <10ppm
Arsenic ≤3ppm <1ppm
Methanol <3000ppm Qualified
Hexane <290ppm Qualified
Total Plate Count <1000cfu/G Qualified
Yeast & Moulds <100cfu/G Qualified
E.Coli Negative(In 10g) Negative
Salmonella Negative(In 25g) Negative
Function&ApplicationBiochemical studies;The clinical drug is fat-soluble vitamin, and is used for the treatment of habitual abortion, threatened abortion, infertility and menopausal disorders
| 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 |
Conclusion:Conform to Ph.Eur./USP/FCC
Remark:
"1" Conduct every tenth batch.
"Certified" indicates datas obtained by statistically designed sampling audits.
Materials Code:4100102
