Specification
|
Concerning Product: |
| Article number | 13472350BEU |
| Trade name / designation / denomination | Monosodium phosphat 2-hydrat, EP/USP |
| CAS number | 13472-35-0 |
| Other names / synonyms | •Phosphoric acid, sodium salt, hydrate (1:1:2);
•Sodium Phosphate, Monobasic, Dihydrate;
•Sodium dihydrogen phosphate dihydrate;
•Sodium phosphate monobasic dihydrate;
•sodium dihydrogen phosphate dihydrate; |
| EC number | 231-449-2
|
| Molecular weight [g / mol] | 156.008 |
| Formula | NaH2PO4+2H2O |
| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
|
passes test |
|
| Appearance |
|
colorless crystals |
Physical parameter |
| Water content |
|
18 – 26,5 |
% |
| Loss on drying |
|
( 130 °C / 4h) 21,5 – 24 |
% |
| pH value |
|
5%: 4,2 – 4,5 |
|
| Reducing substances |
|
passes Test |
|
Identity |
| Assay |
Ph.EUR |
on dried basis 98 – 100,5 |
% |
| Assay |
USP |
on dried basis 98 – 103,0 |
% |
| Identification |
|
passes test |
|
Impurities |
| Sulphates (SO4) |
|
≤ 300 |
ppm |
| Impurity |
|
Al, Ca and related elements: passes Test |
% |
| Impurity |
|
H2O-insoluble substances ≤ 0,2 |
% |
Elemental Impurities |
| Arsenic (As) |
|
≤ 1 |
ppm |
| Cadmium (Cd) |
|
≤ 0,5 |
ppm |
| Chlorides (Cl) |
|
≤ 140 |
ppm |
| Cobalt (Co) |
|
≤ 5 |
ppm |
| Iron (Fe) |
|
≤ 10 |
ppm |
| Mercury (Hg) |
|
≤ 1 |
ppm |
| Nickel (Ni) |
|
≤ 6 |
ppm |
| Lead (Pb) |
|
≤ 0,5 |
ppm |
| Vanadium (V) |
|
≤ 3 |
ppm |
Supplemental information:
Shelf life:
2 years
Note:
Country of Origin: Germany
Following ICH Q3D guideline on elemental impurities and the risk assessment for oral route of administration the manufacturer confirms, that class 2B or class 3 elements are not intentionally added during the manufacture of above mentioned product.
The aqueous solution of Monosodium Phosphate has an acid action. Monosodium Phosphate melts on heating to give Polyphosphates of varying chain lengths. Monosodium Phosphate has good buffering properties in the acid range. Due to its physical properties and the content of water of hydration, Monosodium Phosphate tends to form lumps. This tendency generally increases over time of storage, especially when the material is exposed to high temperature, high humidity levels or high pressure. These lump formations
The manufacturer confirms that none of the solvents listed in the supplement 467 "Residual solvents" of the United States Pharmacopeia and chapter 5.4 of the European Pharmacopeia are used in the manufacture of above mentioned product. He confirms that above mentioned product complies with the ICH Q3C guidline for residual solvents
Storage conditions:
Store at room temperature in protected areas and in well closed containers. As storage conditions, we recommend peak temperatures being below 30°C and the relative humidity being constantly below 65%
Usage:
For excipient use
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
|
Waltrop, 18. Dec. 2023
|
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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