Specification
|
Concerning Product: |
| Article number | 5785444LPUL |
| Trade name / designation / denomination | Tri-Calciumcitrat-4-hydrat
Pharma quality |
| CAS number | 5785-44-4 |
| Other names / synonyms | •Calcium citrate tetrahydrate;
•Calcium citrate tetrahydrate micronised;
•tricalcium 2-hydroxypropane-1,2,3-tricarboxylate tetrahydrate; |
| Molecular weight [g / mol] | 570.49452 |
| Formula | C12H18Ca3O18 |
| Parameter |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
complies |
|
| Appearance |
white powder |
|
Physical parameter |
| Loss on drying |
( 150 °C / 4h) 10.0 – 13.3 |
% |
| Loss on drying |
( 180 °C / 4h) 11.5 – 13.5 |
% |
| pH value |
5.0 – 6.0 |
|
| Solubility |
Hydrochloric acid-insoluble ≤ 0,2 |
% |
Identity |
| Assay |
Ca3(C6H5O7)2 * 4H2O ≥ 98,0 |
% |
| Assay |
calculated on dried substance 98,0 – 100,5 |
% |
| Identification |
Behavior against sulfuric acid: complies |
| Identification |
complies |
|
Impurities |
| Oxalate (as anhydros Oxalic Acid) |
≤ 0,03 |
ppm |
| Oxalate (as anhydros Oxalic Acid) |
(C2H2O4) ≤ 0,01 |
ppm |
| Sulphates (SO4) |
≤ 0,01 |
% |
| Impurity |
Carbonat: complies |
% |
Residual Solvents |
| Residual solvents |
We confirm that the product is in the production, bottling and Storage with the in the Ph.Eur. (I 283/95) and USP <467> organic solvents ("residual solvents") are not in contact comes. |
Elemental Impurities |
| Aluminium (Al) |
≤ 200 |
mg/kg |
| Arsenic (As) |
≤ 1 |
mg/kg |
| Cadmium (Cd) |
≤ 1 |
ppm |
| Chlorides (Cl) |
≤ 0,01 |
% |
| Fluorine (F) |
≤ 30 |
mg/kg |
| Iron (Fe) |
≤ 0,1 |
% |
| Mercury (Hg) |
≤ 1 |
mg/kg |
| Lead (Pb) |
≤ 0,001 |
% |
| Lead (Pb) |
(Pb, ICH-Q3D): ≤ 1 |
ppm |
Microbiological data |
| Total Plate Count |
≤ 2000 |
CFU/g |
| Yeast and Mould |
≤ 200 |
CFU/g |
Regulatory information:
Elemental Impurities:
Other elements are not knowingly added. The specification includes monograph-specific element contaminants. These will continue to be considered in the specification according to the monograph specification.
The manufacturer confirms that the product has been evaluated according to the ICH Guideline Q3D and that no elements have been identified as potential contaminants.
Unless otherwise specified or specified, the presence of Class 1-3 elements (classification according to ICH Q3D) above the Q3D Option 1 limit is unlikely according to a review.
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
|
Waltrop, 05. Nov. 2019
|
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.
|
|
