Specification
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Concerning Product: |
| Article number | 31900 |
| Trade name / designation / denomination | Natriumcyclamat krist. |
| CAS number | 139-05-9 |
| Other names / synonyms | •CYCLOHEXYLSULFAMIC ACID;
•Cyclamic Acid;
•Cyclamic Acid-d11;
•N-Cyclohexylsulfamic Acid;
•N-Cyclohexylsulfamic acid;
•Sodium Cyclamate;
•Sodium Cyclamate (Sodium N-cyclohexylsulfamate) crystalline;
•Sodium Cyclamate (Sodium N-cyclohexylsulfamate) powder;
•Sodium N-Cyclohexylsulfamate;
•Sodium N-cyclohexylsulfamate; |
| EC number | 205-348-9
|
| Customs tariff number / CN code / TARIC | 29299000 |
| Molecular weight [g / mol] | 201.219 |
| Formula | C6H12NO3SNa |
| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
Ph.Eur. |
clear and colourless |
| Colour |
|
white or almost white |
| Flavor and taste |
|
very sweet: approximately 30 to 40 times sweeter than sucrose |
| Odour |
|
odourless |
|
Physical parameter |
| Form |
|
crystalline powder or crystals |
| Loss on drying |
PRO.333 |
≤ 1,0 |
% |
| pH value |
Ph.Eur. |
(10% in H2O): 5,5 – 7,5 |
| Solubility |
|
in water: soluble; in ethanol: slightly soluble |
Identity |
| Assay |
PRO.333 |
98,5 – 101,0 |
% |
| Identification |
Ph.Eur. |
(A) I.R. spec.: conforms with standard |
| Identification |
Ph.Eur. |
(E) Sodium reaction: positive |
| UV spectroscopy |
Ph.Eur. |
@ 270 nm: ≤ 0,10 |
|
Impurities |
| Sulphates (SO4) |
Ph.Eur. |
≤ 0,1 |
% |
| Impurity |
Ph.Eur. |
Aniline(1): ≤ 0,5 |
ppm |
| Impurity |
Ph.Eur. |
Cyclohexylamine(1): ≤ 8 |
ppm |
| Impurity |
Ph.Eur. |
NN-Dicyclohexylamine(1): ≤ 0,5 |
ppm |
| Impurity |
Ph.Eur. |
NN-Dicyclohexylsulfamide(1): ≤ 1 |
ppm |
| Impurity |
Ph.Eur. |
Sulphamic acid: ≤ 0,1 |
% |
Residual Solvents |
| Residual solvents |
GC |
according to ICH Guideline Q3C (*) |
| Residual solvents |
GC |
Xylene(1, *): ≤ 1 |
ppm |
Elemental Impurities |
| Arsenic (As) |
ICP-MS |
(1, *) ≤ 1,5 |
ppm |
| Lead (Pb) |
ICP-MS |
(*) ≤ 0,5 |
ppm |
| Selenium (Se) |
ICP-MS |
(1, *) ≤ 15 |
ppm |
Microbiological data |
| Aerobic microorganisms |
Ph.Eur. |
(1, *) ≤ 1000 |
CFU/g |
| Coliform bacteria |
Ph.Eur. |
absence(1, *) |
/0,1 g |
| Salmonella |
Ph.Eur. |
absence(1, *) |
/25 g |
| Yeast and Mould |
Ph.Eur. |
(1, *) ≤ 100 |
CFU/g |
Annotation:
* n.d. = not detectable / nicht messbar
*: Periodically tested
(1): Limit of the European Pharmacopoeia: higher or not defined.
Regulatory information:
Elemental Impurities (ICP-MS):
according to ICH Guideline Q3D (*)
Registration status:
This product is manufactured using excipient Good Manufacturing Practices (GMP).
Supplemental information:
Shelf life:
5 years
Complies with monographie:
Ph.Eur. 10th edition, monograph No. 0774
PURITY Conform to European Pharmacopoeia 10 th edition, to ICH Guidelines Q3C on Residual Solvents and Q3D on Elemental Impurities, and to Regulation (EU) 231/2012 and amendments on Specification for Food Additives.
Packing:
25 kg cardbox; 50 kg drum; 500 kg big bag
Regional origin:
EU
Usage:
FOOD and DRINKS according to the Regulation (EU) 1333/2008 and Regulation (EU) 1129/2011, and subsequent modifications. PHARMACY according to European Pharmacopoeia 10th edition.
Sweetener for food E-952
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
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Waltrop, 22. Dec. 2022
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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
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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
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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
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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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