Specification
|
Concerning Product: |
| Article number | 35300 |
| Trade name / designation / denomination | Saccharin Na, Dihydrat (15%)
450 fach 40-80 mesh, EP/USP |
| 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
612-173-5
|
| 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 |
Ph.Eur. |
clear and colourless |
| Appearance |
|
efflorescent in dry air |
| Colour |
|
white or almost white |
| Flavor and taste |
|
intensly sweet (aprox. 450 times than sucrose) |
| Odour |
|
odourless |
|
Physical parameter |
| Acidity/Alkalinity |
Ph.Eur. |
complies |
|
| Form |
|
crystalline powder |
| Loss on drying |
PRO.332 |
≤ 15,0 |
% |
| pH value |
PRO.332 |
(10% in H2O): 6,0 – 7,5 |
| Solubility |
|
freely soluble in watersparingly soluble in ethanol (96 per cent). |
Identity |
| Assay |
Ph.Eur. |
99,0 – 101,0 |
% |
| Identification |
Ph.Eur. |
Reaction of sodium: positive |
| Infrared absorbtion spectrometry |
Ph.Eur. |
positive |
|
Impurities |
| Readily carbonizable substances |
Ph.Eur. |
complies |
|
| Impurity |
PRO.332(1) |
1,2-benzisothiazolin-3-one (BIT): ≤ 5 |
ppm |
| Impurity |
Regulation (EU) 231/2012(1) |
Benzoates ＆ Salicylates: pass the test |
| Impurity |
PRO.332(1, 2) |
Methyl anthranilate ≤ 1 |
ppm |
| Impurity |
Ph.Eur. |
o-TSA (toluenesulphonamide):
≤ 10 |
ppm |
| Impurity |
PRO.103(1, 2) |
p-sulphonamidobenzoic acid ≤ 10 |
ppm |
| Impurity |
Ph.Eur. |
p-TSA (toluenesulphonamide):
≤ 10 |
ppm |
Residual Solvents |
| Residual solvents |
GC |
conform to ICH Guideline Q3C |
Elemental Impurities |
| Arsenic (As) |
ICP-MS(1) |
≤ 1,5 |
ppm |
| Lead (Pb) |
ICP-MS(1) |
≤ 0,5 |
ppm |
| Selenium (Se) |
ICP-MS(1) |
≤ 15 |
ppm |
Organic volatile impurities |
| Org. volat. Imp. Total |
USP(1, 2) |
complies |
|
Microbiological data |
| Aerobic microorganisms |
Ph.Eur.(1) |
≤ 1000 |
CFU/g |
| Coliform bacteria |
Ph.Eur.(1) |
absence |
/ 0.1 g |
| Salmonella |
Ph.Eur.(1) |
absence |
/ 25 g |
| Yeast and Mould |
Ph.Eur.(1) |
≤ 100 |
CFU/g |
Annotation:
(2): This substance is not expected to be present in the final product. It is originated in a different route of synthesis and therefore not expected to be present and not tested. It is just listed in respect to the monography.
* n.d. = not detectable / nicht messbar
(1): Limit of the European Pharmacopoeia: higher or not defined.
Regulatory information:
Elemental Impurities (ICP-MS):
conform to ICH Guideline Q3D
Registration status:
PURITY according to European Pharmacopoeia 11th ed., to ICH Guidelines Q3C on Residual Solvents and Q3D on Elemental Impurities, to Regulation (EU) 231/2012 on Specifications for Food Additives, and subsequent amendments, and USP (43)
This product is manufactured according to the Good Manufacturing Practices (GMP) for excipients.
Supplemental information:
Shelf life:
5 years
Complies with monographie:
Ph.Eur. 11th edition, monograph No. 0787
Packing:
card boxes 25 kg, drums 50 kg
Regional origin:
EU
Usage:
FOOD and DRINKS according to the Regulations (EC) 1333/2008 and (EU) 1129/2011, and amendments. PHARMACY according to European Pharmacopoeia 11th edition.
Sweetener for food E-954
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
|
Waltrop, 23. Jan. 2026
LF-Basis: 21 (2024-04-02)
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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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