Chemische Werke Hommel GmbH & Co. KG  

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Specification

Concerning Product:
Article number 67970NEUL1
Trade name / designation / denomination Vitamin D3 100TIU/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 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 Cholecalciferol 100 000 IU/g (EP) in a matrix of sucrose, gum arabic (E 414), corn starch, medium-chain triglycerides (vegetable oil), tricalcium phosphate (E 341) and DL-alpha tocopherol (E 307).
Colour white to off-white

Physical parameter
Form visual free-flowing powder consisting of spherical particles
Loss on drying PE / USP ≤ 5 %

Identity
Assay HPLC (incl.pre D) ≥ 100000 IU/g

Impurities
Heavy Metals (as Pb) ≤ 10 mg/kg

Elemental Impurities
Arsenic (As) ≤ 1 mg/kg
Cadmium (Cd) ≤ 0,5 mg/kg
Mercury (Hg) ≤ 0,1 mg/kg

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

Particle size distribution
Particles sieving (USP) < 100 mesh: ≤ 15 %
Particles sieving (USP) < 20 mesh: ≥ 100 %
Particles sieving (USP) < 40 mesh: ≥ 90 %
Annotation:
1 international Unit (IU) = 0.025 μg Vitamin D3


Regulatory information:

BSE/TSE statement: Risk of BSE/TSE contamination can be excluded.


Supplemental information:

Shelf life: 2 years

Derivation: active substance: synthetic, animal
formulation: synthetic, vegetable, mineral

Storage conditions: Protect from light and store cool and dry in well-closed original packaging. The temperature should not exceed 15 °C.


Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
Waltrop, 05. Aug. 2019
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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