Chemische Werke Hommel GmbH & Co. KG  

Chemische Werke Hommel GmbH & Co. KG\n

Im Wirrigen 25
D-45731 Waltrop
Tel.: +49 2309 60699-0
Fax: +49 2309 60699-30
www.hommel-pharma.com
info@hommel-pharma.com

Specification

Concerning Product:
Article number 10191410V01
Trade name / designation / denomination DL-alpha-Tocopherol (Vitamin E) EP,USP
CAS number 10191-41-0
Other names / synonyms•(+)-a-Tocopherol; •(+)-alpha-Tocopherol; •(+/-)-alpha-Tocopherol; •2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-3,4-dihydro-2H-1-benzopyran-6-ol; •3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol; •?-Tocopherol; •D-?-TOCOPHEROL; •D-alpha-Tocopherol; •DL-α-Tocopherol; •DL-?-TOCOPHEROL;
EC number233-466-0
Molecular weight [g / mol]430.7061
FormulaC29H50O2
May cause long lasting harmful effects to aquatic life.
Avoid release to the environment. Dispose of contents/container in accordance with local/regional/(inter)national regulations.


Parameter Test Method Specification Unit

Organoleptic test
Appearance Viscous, yellow to brown oil

Physical parameter
Acidity/Alkalinity USP must comply
Activity index (acetic acid) USP/FCC Vitamin E activity (*) 1056  –  1122 I.U./g
Refraction index Ph. Eur. 2.2.6 (**) 1.503  –  1.507
Specific Optical Rotation Ph. Eur. -0.01 to 0.01°
Specific Optical Rotation USP -0.01 to 0.01° (**)

Identity
Absorbance of Solution Ph. Eur. 4. Ed.2002 (at max. 292 nm in ethanol) (**) 72  –  76
Assay PM00829QC (equivalent to USP) all-rac-alpha-tocopherol (GC): 960  –  1020 mg/g
Assay PM00829QC (equivalent to USP) all-rac-alpha-tocopherol (GC): 96.0  –  102.0 %
Assay PM00829QC (equivalent to Ph. Eur.) all-rac-alpha-tocopherol (GC): 96.0  –  102.0 %
Identification PM00829QC (equivalent USP) (GC) must comply

Impurities
Sulphated ash (**) ≤ 0.1 g/100g
Impurity PM00829QC (equivalent to Ph. Eur.) A: ≤ 0.5 %
Impurity PM00829QC (equivalent to Ph. Eur.) Any other: ≤ 0.25 %
Impurity PM00829QC (equivalent to Ph. Eur.) B: ≤ 1.5 %
Impurity PM00829QC (equivalent to Ph. Eur.) Sum of impurity C and D: ≤ 1.0 %
Impurity PM00829QC (equivalent to Ph. Eur.) total impurities: ≤ 2.5 %

Residual Solvents
Residual solvents (**) Heptane: ≤ 0.5 g/100g
Residual solvents (**) Methanol: ≤ 3000 ppm

Elemental Impurities
Arsenic (As) (**) ≤ 1 ppm
Cadmium (Cd) (**) ≤ 0.5 ppm
Mercury (Hg) (**) ≤ 0.1 ppm
Lead (Pb) (**) ≤ 0.5 ppm
Zinc (Zn) (**) ≤ 10 ppm
Annotation:
(*) Biological activity and equivalence: 1 mg all-rac-alpha-tocopherol = 0.50 mg RRR-alpha-Tocopherol = 1.1 IU Vitamin E - e.g., 960 mg/g all-rac-alpha- tocopherol is equal to 480 mg/g RRR-alpha-tocopherol and 1020 mg/g all-rac-alpha-tocopherol is equal to 510 mg/g RRR-alpha-tocopherol. (Please notice, in certain countries/regions the previous conversion factor may remain: 1.1 IU Vitamin E = 1 mg all rac-alpha-tocopherol = 0.74 mg RRR- alpha-Tocopherol).

(**) ensured by quality assurance measures and therefore tested randomly only.


Supplemental information:

Complies with monographie: "All-rac-alpha-Tocopherol" of FCC | current specification for food additives of EU regulation "E 307, alpha-Tocopherol"

"All-rac-alpha-Tocopherol" of Ph. Eur.

"Vitamin E" of USP


Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
Waltrop, 12. Feb. 2026
LF-Basis: 9 (2024-05-01)
We only confirm that we took over the data from our supplier accordingly. Despite careful working, errors in the takeover are not totally excluded. Some or all parts off the document may be translated due to our best knowledge from the original to give a better understanding. If you have any questions about specific details, please call us directly. Unless otherwise marked, these data do not originate from us and have not been tested by us on the correctness. The above information corresponds to the present state of our knowledge and is intended as a general description of our products and their possible applications. We make no warranties, expressed or implied, as to the information's accuracy, adequacy, sufficiency or freedom from defect and assumes no liability in connection with any use of this information. Any user of this product is responsible for determining the suitability of our products for its particular application. The foregoing information does not absolve the buyer of its own tests. Observing existing laws and regulations, is the responsibility of the buyer of our product. Nothing included in this information waives any of our General Terms and Conditions of Sale, which control unless it agrees other in writing. Any existing intellectual/industrial property rights must be observed. Due to possible changes in our products and applicable national and international regulations and laws, the status of our products could change. Material Safety Data Sheets providing safety precautions, that should be observed when handling or storing our products, are available upon request and are provided in compliance with applicable law. The user should obtain and review the applicable Material Safety Data Sheet information before handling any of these products. For additional information, please contact us.