Specification
|
Concerning Product: |
| Article number | 532434V01 |
| Trade name / designation / denomination | Vitamin B1 Mononitrat, Food Grade (Thiamin Mononitrat) |
| CAS number | 532-43-4 |
| Other names / synonyms | •2-[3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-thiazol-3-iumyl]ethanol nitrate;
•Thiamine mononitrate;
•Vitamin B1 mononitrate;
•thiamine nitrate; |
| EC number | 208-537-4
|
| Customs tariff number / CN code / TARIC | 29362200 |
| Molecular weight [g / mol] | 327.35948 |
| Formula | C12H17N5O4S |
| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
EP |
Clear, not more intense than Y7 |
| Appearance |
|
White crystals or crystalline powder |
Physical parameter |
| Loss on drying |
USP |
≤ 1,0 |
% |
| pH value |
EP |
6,8 – 7,5 |
|
Identity |
| Assay |
USP |
on dry basis 98,0 – 102,0 |
% |
| Identification |
USP |
Color reaction: A brown ring forms at the junction of the two liquids |
| Identification |
USP |
Precipitate reaction: A white precipitate results from treatment with mercuric chloride, and a red-brown precipitate results from treatment with iodine, treatment with mercuric-potassium iodide and trinitrophenol also causes precipitates to form |
| Identification |
USP |
Precipitate reaction: The color of the solution changes to brown and, on standing, a precipitate of lead sulfide forms |
| Identification |
USP |
Reaction of fluorescence: The air-liquid meniscus shows a vivid blue fluorescence which disappears when the mixture is slightly acidified and reappears when it is again made alkaline |
Impurities |
| Residue on ignition |
USP |
≤ 0,1 |
% |
| Related substances |
EP |
here related compounds: ≤ 1,0 |
% [w/w] |
| Related substances |
EP |
Impurity A: ≤ 0,15 |
% [w/w] |
| Related substances |
EP |
Impurity B: ≤ 0,6 |
% [w/w] |
| Related substances |
EP |
Impurity C: ≤ 0,4 |
% [w/w] |
| Related substances |
EP |
Total impurities ≤ 1,0 |
% [w/w] |
| Related substances |
EP |
Unspecified impurities ≤ 0,1 |
% [w/w] |
Residual Solvents |
| Residual solvents |
|
Methanol: ≤ 0,3 |
% |
Elemental Impurities |
| Arsenic (As) |
|
≤ 0,5 |
mg/kg |
| Cadmium (Cd) |
|
≤ 0,5 |
mg/kg |
| Chlorides (Cl) |
USP |
≤ 0,06 |
% |
| Mercury (Hg) |
|
≤ 0,1 |
ppm |
| Lead (Pb) |
|
≤ 0,5 |
mg/kg |
Microbiological data |
| Aerobic microorganisms |
|
Total Aerobic Microbial Count: ≤ 100 |
CFU/g |
| Escherichia Coli. |
|
Negative/g |
|
| Salmonella |
|
Negative/10g |
|
| Staphylococcus Aureus |
|
Negative/g |
|
| Yeast and Mould |
|
Total Yeasts and Moulds Count: ≤ 10 |
CFU/g |
Supplemental information:
Shelf life:
4 years
Note:
The material meets all requirements of the valid compendia of BP, EP, USP and FCC when tested accordingly.
Storage conditions:
Preserve in tight, non-metallic containers, protected from light.
Regional origin:
China
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
|
Waltrop, 13. May. 2025
LF-Basis: (2024-08-27)
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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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