Chemische Werke Hommel GmbH & Co. KG  

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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 50146NF
Trade name / designation / denomination Vitamin D2
CAS number 50-14-6
Other names / synonyms•3-[2-[1-(5,6-dimethylhept-3-en-2-yl)-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylene-1-cyclohexanol; •ergocalciferol;
EC number200-014-9
EC index number603-179-00-9
Customs tariff number / CN code / TARIC29362900
Molecular weight [g / mol]396,66
FormulaC28H44O
Danger UN 2811, 6.1 (Giftige Stoffe), II
Toxic if swallowed. Toxic in contact with skin. Fatal if inhaled. Causes damage to organs through prolonged or repeated exposure .


Parameter Specification Unit

Organoleptic test
Colour white
Discription Microencapsulated Ergocalciferol (Vitamin D2)/ Food grade

Physical parameter
Form fine, free flowing powder
Loss on drying ≤ 8 %
Bulk density 0,40  –  0,60 g/ml
Solubility not soluble in water, may be dispersed in water

Identity
Assay Vitamin D2 % ≥ 0,25
Assay Vitamin D2 IU/g ≥ 100 000

Elemental Impurities
Arsenic (As) ≤ 1 ppm
Cadmium (Cd) ≤ 1 ppm
Mercury (Hg) ≤ 0,1 ppm
Lead (Pb) ≤ 3 ppm

Fatty Acid composition
Saturated fatty acids 2,0 g

Nutritional data
Calories 1502 kJ
Calories 359 kcal
Carbohydrates 84,0 g
All Fats 2,0 g

Microbiological data
Aerobic microorganisms ≤ 1000 CFU/g
Escherichia Coli. neg. in 1 g
Salmonella neg. in 25 g
Yeast and Mould ≤ 200 CFU/g

Particle size distribution
Particles µm: ≤ 1000
Particles mesh: ≤ 18

Regulatory information:

Allergens statement: According to Annex II of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25th October 2011 and its amendment (EU) No 78/2014 on substances or products the above mentioned product does NOT cause allergies or intolerances and does NOT contain any allergens which have to be labelled according to these regulations.

BSE/TSE statement:
The product does not contain animal ingredients.
The risk of BSE/TSE contamination can be excluded.

GMO statement: Genetic engineering:
For the above mentioned product there is no obligation of g.m.o. labelling as defined by the Regulations (EC) No 1829/2003 and 1830/2003 of the European Parliament and the Council of 22nd September 2003.

Irradiated Status: Product has not been treated with ionizing radiation and does not contain any ingredients which have been treated with ionizing radiation.

Nanoparticles: The product does not contain any raw materials, ingredients or additives in nanoparticle size as per definition of Regulation (EU) No 1169/2011 respectively Regulation (EU) No 2015/2283.


Supplemental information:

Derivation:
The product contains palm based components.

Fermentation of vegetables. The product contains NO animal ingredients.

Maltodextrin (maize)
Ethyl cellulose (E 462) (wood pulp)
Medium chain triglycerides (palm)
Tocopherol rich extract (E 306) (sunflower)
Vitamin D2 (Ergocalciferol) (yeast fermentation of sugar cane)

Note:
Traceability
According to Regulation (EC) No 178/2002 the traceability of the raw materials for the product is guaranteed one step backwards and of produced batches one step forward. All instructions, which are necessary to take these steps, are implemented in the Quality manual and management system according to IFS and BRC.

Storage conditions: Protect from light and store cool and dry in well-closed original packaging. Manufacturer has recently completed an updated stability study for the product and determined that optimum storage condition should be changed from temperature of 4-15°C to a temperature of 2-8°C.
Please be aware that the product will be stored at us as well as at our supplier at room temperature.

Packing:
The primary packaging of the above mentioned product is suitable for food.

Usage:
The product is suitable for a vegetarian nutrition.
The product is suitable for a vegan nutrition.
The product is suitable for lactose intolerance diet.
The product is suitable for people with coeliac disease and sprue.
The product is in compliance with Jewish dietary laws.
The product is in compliance with Islamic dietary laws.

Food Additive


Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
Waltrop, 17. May. 2023
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.


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