Chemische Werke Hommel GmbH & Co. KG  

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D-45731 Waltrop
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info@hommel-pharma.com

Specification

Concerning Product:
Article number 67970CL10
Trade name / designation / denomination Vitamin D3, 100.000 IE/g
CAS number 67-97-0
Other names / synonyms•Cholecalciferol; •Vitamin D3; •colecalciferol;
EC number200-673-2
EC index number603-180-00-4
Customs tariff number / CN code / TARIC29362900
Molecular weight [g / mol]384,65
FormulaC27H44O
Danger UN 2811/2811, 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 .
Wear protective gloves/protective clothing/eye protection/face protection. IF INHALED: IF exposed or if you feel unwell: Immediately call a POISON CENTER or doctor/physician. Wash with plenty of soap and water.


Parameter Test Method Specification Unit

Organoleptic test
Appearance visual white, free-flowing powder

Physical parameter
Loss on drying USP ≤ 5,0 %
Solubility in Water: soluble

Identity
Assay HPLC/EP ≥ 100000 IU/g
Assay ca. 0,3 %
Identification UV/USP Vitamin D3: positiv

Impurities
Pesticides According to Reg. (EC) 396/2005 and amendments
Impurity According to Reg. (EC) 1881/2006 and amendments
Impurity TiO2: Absent According to Reg. (EC) 2022/63

Residual Solvents
Residual solvents According to Dir. (EC) 2009/32 and amendments

Microbiological data
Coliform bacteria ≤ 30 MPN/100g
Escherichia Coli. Neg.
Enterobacteriaceae neg./10g
Salmonella neg.
Staphylococcus Aureus neg.
Total Plate Count ≤ 1000 CFU/g
Yeast and Mould ≤ 100 CFU/g

Particle size distribution
Particles < 40 mesh: ≤ 90 %

Regulatory information:

Allergens statement: free according to Reg. (EC) 1169/2011

BSE/TSE statement: Risk Free BSE/TSE

Ethylene Oxide (EtO) Statement: no ETO used in the production flow

Food Grade Status: According to Reg. (EC) 178/2002

GMO statement: GMO Free According to Reg. (EC) 1829/2003 and 1830/2003 and amendments

Irradiated Status: No ionization or other radiation is permitted According to Reg. (EC) 1999/2 and 1999/3 and amendments

Nanoparticles: Absent According to Reg. (EC) 1169/2011


Supplemental information:

Shelf life: 2 years if sealed and store away from direct sun light

Derivation: Carrier: Starch (42.4%), Maltodextrin (49.5%), Sucrose (7.8%)

synthetic

Storage conditions: Store in a well-closed container away from moisture.

Packing: According to Reg. (EC) 1935/2004 and Nr. 10/2011 and amendments

Regional origin: CN

Usage: Food


Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
Waltrop, 02. Dec. 2022
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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