Specification
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Concerning Product: |
| Article number | 35330 |
| Trade name / designation / denomination | Saccharin 550-fach 60-100 Mesh |
| CAS number | 81-07-2 |
| Other names / synonyms | •1,2-benzisothiazol-3(2H)-one 1,1-dioxide;
•Saccharin Acid 20 mesh;
•Saccharin Acid 60-100 mesh;
•o-benzoicsulfimide; |
| EC number | 201-321-0
|
| Customs tariff number / CN code / TARIC | 29251100 |
| Molecular weight [g / mol] | 183,18 |
| Formula | C7H5NO3S |
| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
Ph.Eur. |
clear and colourless |
| Colour |
|
White or almost white |
| Flavor and taste |
|
Intensely sweet (approx. 550 times sweeter than sucrose) |
| Odour |
|
odourless |
|
Physical parameter |
| Form |
|
micro crystals or crystalline powder |
| Loss on drying |
PRO.110 |
≤ 1,0 |
% |
| Solubility |
|
Sparingly soluble in boiling water and in ethanol, slightly soluble in cold water. Soluble in dilute solutions of alkali hydroxides and carbonates. |
Identity |
| Assay |
Ph.Eur. |
99,0 – 101,0 |
% |
| Identification |
Ph.Eur. |
C (IR Spectrum): positive |
Impurities |
| Readily carbonizable substances |
Ph.Eur. |
complies (*) |
|
| Sulphated ash |
Ph.Eur. |
≤ 0,2 |
% |
| Impurity |
PRO.87 |
1,2-benzisotiazoline-3-one (BIT) ≤ 5 |
ppm |
| Impurity |
Regulation 231/2012/CE (1) |
Benzoates ＆ Salicylates: not detectable |
| Impurity |
PRO.87 |
Methyl anthranilate: ≤ 1 |
ppm |
| Impurity |
Ph.Eur. |
o-Toluenesulphonamide: ≤ 10 |
ppm |
| Impurity |
PRO.103 |
p-sulphonamidobenzoic acid: ≤ 10 |
% |
| Impurity |
Ph.Eur. |
p-Toluenesulphonamide: ≤ 10 |
ppm |
Residual Solvents |
| Residual solvents |
GC |
according to ICH Guideline Q3C (*) |
Elemental Impurities |
| Arsenic (As) |
ICP-MS. |
(*) ≤ 1,5 |
ppm |
| Lead (Pb) |
ICP-MS. |
(*) ≤ 0,5 |
ppm |
| Selenium (Se) |
ICP-MS. |
(*) ≤ 15 |
ppm |
Organic volatile impurities |
| Org. volat. Imp. Total |
USP |
complies |
|
Microbiological data |
| Aerobic microorganisms |
Ph.Eur. |
(*) ≤ 1000 |
CFU/g |
| Coliform bacteria |
Ph.Eur. |
absence |
/ 0,1 g |
| Salmonella |
Ph.Eur. |
absence |
/ 25 g |
| Yeast and Mould |
Ph.Eur. |
(*) ≤ 100 |
CFU/g |
Annotation:
*: Periodically tested
Regulatory information:
Elemental Impurities (ICP-MS.):
according to ICH Guideline Q3D (*)
Registration status:
This product is manufactured according to the Good Manufacturing Practices (GMP) for excipients.
Supplemental information:
Released by manufacturer:
2020-06-30
Shelf life:
5 years
Complies with monographie:
Ph. Eur. Monograph No. 0947
PURITY According to the European Pharmacopoeia 10 th edition, ICH Guidelines Q3C(R1) on Residual Solvents and ICH Q3D(R6) on Elemental Impurities, and Regulation (EU) 231/2012 ON Specifications for Food Additives and amendments.
Packing:
25 kg cardbox, 50 kg drum
Regional origin:
EU
Usage:
FOOD and DRINKS according to Regulations (EU) 1333/2008 and 1129/2011, and subsequent modifications. PHARMACY according to European Pharmacopoeia 10th edition.
Version of manufacturer:
17
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
|
Waltrop, 21. Jan. 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
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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