Specification
|
Concerning Product: |
| Article number | 6132043LPEY |
| Trade name / designation / denomination | Tri-Natriumcitrat-2-hydrat EP, Krist. |
| CAS number | 6132-04-3 |
| Other names / synonyms | •1,2,3-Propanetricarboxylic acid, 2-hydroxy-, sodium salt, hydrate (1:3:2);
•Sodium Citrat cystalline;
•Sodium Citrat powder;
•trisodium 2-hydroxypropane-1,2,3-tricarboxylate dihydrate;
•trisodium citrate dihydrate; |
| EC number | 612-118-5
|
| Customs tariff number / CN code / TARIC | 29181500 |
| Molecular weight [g / mol] | 294.09957 |
| Formula | C6H9Na3O9 |
| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
10% |
complies |
|
| Appearance |
|
white crystals |
|
Physical parameter |
| Acidity/Alkalinity |
PE |
complies |
|
| Loss on drying |
|
11,0 – 13,0 |
% |
Identity |
| Assay |
on anhydrous substance |
99,0 – 101,0 |
% |
| Identification |
citrat |
positiv |
|
| Identification |
Na |
positiv |
|
Impurities |
| Oxalate (as anhydros Oxalic Acid) |
|
≤ 0,03 |
% |
| Sulphates (SO4) |
|
≤ 0,015 |
% |
Elemental Impurities |
| Chlorides (Cl) |
|
≤ 0,005 |
% |
Microbiological data |
| Total Plate Count |
TAMC |
≤ 2000 |
CFU/g |
| Yeast and Mould |
TYMC |
≤ 200 |
CFU/g |
Annotation:
Unless otherwise stated or specified, the presence of the elements of
class 1-3 (classification according to ICH Q3D) above the Q3D Option 1
limit value is unlikely according to our review. No further elements are
knowingly added. The specification includes monograph-specific element
impurities. These will continue to be taken into account in the
specification in accordance with the monograph requirement.
Behavior against sulfuric acid comply
We confirm that the product is in production, bottling and
Storage with the Ph.Eur. (I 283/95) called organic Solvents ("Residual
Solvents") does not come into contact. Heavy metal parameters of this
specification were determined in accordance with ICH guideline Q3D on
elementary impurities on the basis of a product-related risk assessment.
The risk assessment was carried out taking into account option 1 (max.
Daily dose 10g / d) for oral use.
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
|
Waltrop, 14. Dec. 2021
|
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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