Specification
|
Concerning Product: |
| Article number | 6155573JEP |
| Trade name / designation / denomination | Saccharin Na 40-80 (JEP) |
| CAS number | 6155-57-3 |
| Other names / synonyms | •1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, sodium salt, dihydrate;
•sodium 1,1-dioxo-1,2-benzothiazol-2-id-3-one dihydrate; |
| EC number | 204-886-1
|
| Customs tariff number / CN code / TARIC | 29251100 |
| Molecular weight [g / mol] | 241.2 (Di hydrated) |
| Formula | C7H4NNaO3S · 2H2O |
| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
|
clear and colourless |
| Appearance |
|
White or almost white crystalline powder |
Physical parameter |
| Acidity/Alkalinity |
EP/USP |
complies |
|
| Loss on drying |
EP/USP |
≤ 15 |
% |
| Solubility |
|
in ethanol (96%): sparingly soluble |
| Solubility |
|
in water: freely soluble |
Identity |
| Assay |
USP |
98,0 – 102,0 |
% |
| Assay |
EP |
99,0 – 101,0 |
% |
| Identification |
EP |
derivation to fluorescent substances: complies |
| Identification |
EP |
derivation to salicylic acid: complies |
| Identification |
EP |
Test for sodium (Nonluminous flame test): yellow color |
| Identification |
EP/USP |
Test for sodium (Potassium Pyroantimonate Solution test): a dense precipitate is formed |
| Infrared absorbtion spectrometry |
EP/USP |
complies |
|
| Melting Point (identity) |
EP |
226 – 230 |
°C |
Impurities |
| Readily carbonizable substances |
EP/USP |
absent |
|
| Impurity |
GC |
all other organic impurities: n.d. * |
| Impurity |
USP |
Benzoate and Salicylate: complies |
| Impurity |
on dry weight basis |
Benzoic acid p-sulphonamide ≤ 25 |
mg/kg |
| Impurity |
on dry weight basis |
o-Toluenesulphonamide ≤ 10 |
mg/kg |
| Impurity |
on dry weight basis |
p-Toluenesulphonamide ≤ 10 |
mg/kg |
Residual Solvents |
| Residual solvents |
|
n.d. * |
|
Elemental Impurities |
| Arsenic (As) |
on dry weight basis |
≤ 2 |
mg/kg |
| Lead (Pb) |
on dry weight basis |
≤ 1 |
mg/kg |
| Selenium (Se) |
on dry weight basis |
≤ 0,003 |
% (w/w) |
Microbiological data |
| Aerobic microorganisms |
|
≤ 100 |
CFU/g |
| Escherichia Coli. |
|
neg. |
|
| Pseudomonas aeruginosa |
|
neg. |
|
| Salmonella |
|
neg. |
|
| Staphylococcus Aureus |
|
neg. |
|
| Yeast and Mould |
|
≤ 100 |
CFU/g |
Particle size distribution |
| Particles |
|
< 180 µm: |
% |
Annotation:
* n.d. = not detectable / nicht messbar
Arsenic/Selenium/Lead/Residual solvents/Other organic impurities(by GC)/Microbes results are quarterly based on statistics.
Supplemental information:
Shelf life:
5 years
Note:
Free from allergen, irradiation, pesticides, GMO, BSE/TSE, DEHP, DINP, DBP, Gluten, Latex, lactose and CMR.
Storage conditions:
Preserve in well-closed containers (USP/FCC); Store at room temerature (USP); In a airtight container (PH. EUR)
Complies with monographie:
EP11.0, USP/NF, JP, KP, E 954, FCC, JECFA
Regional origin:
RK
Conclusion:
The above specification and analytical method conform to the Pharmaceutical grade (Ph. Eur., USP/NF, JP, KP, etc.,) and Food grade (E954, FCC, JECFA, etc.,).
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
|
Waltrop, 26. Oct. 2023
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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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