| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
5% in H2O |
complies |
|
| Appearance |
|
white crystalline powder |
Physical parameter |
| Acidity/Alkalinity |
0.1 M NaOH |
≤ 1.5 |
ml |
| Loss on drying |
@ 150 °C; 4 h |
≤ 12.0 |
% |
Identity |
| Assay |
|
Mg (o.d.b.): 11.0 – 12.5 |
% |
| Identification |
Ph.Eur. |
A: positive |
|
| Identification |
Ph.Eur. |
B (Phosphat): positive |
| Identification |
Ph.Eur. |
Magnesium: positive |
Impurities |
| Heavy Metals (as Pb) |
|
≤ 20 |
ppm |
| Soluble part |
|
Glycerol in Ethanol: ≤ 1,5 |
% |
| Phosphate (PO4) |
|
≤ 0.5 |
% |
| Sulphates (SO4) |
|
≤ 0.1 |
% |
Residual Solvents |
| Residual solvents |
|
The product never comes in the production, filling and storage with the organic solvents ("Residual Solvents") mentioned in the Ph.Eur. (ICH 283/95) in contact. |
Elemental Impurities |
| Chlorides (Cl) |
|
≤ 0.15 |
% |
| Iron (Fe) |
|
≤ 150 |
ppm |
| Nickel (Ni) |
ICH-Q3D |
≤ 50 |
ppm |
Microbiological data |
| Total Plate Count |
|
≤ 2000 |
CFU/g |
| Yeast and Mould |
|
≤ 200 |
CFU/g |
Annotation:
o.d.b. = on dried basis / auf getrockneter Basis
Regulatory information:
Elemental Impurities:
Heavy metal parameters of this specification were acc. ICH guideline Q3D for elemental contaminants based on a product-related risk assessment. The risk assessment was carried out considering option 1 (max. Daily dose 10 g/d) for oral use.
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.
Unless otherwise 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.
Supplemental information:
Released by manufacturer:
2020-01-30
Complies with monographie:
Ph.Eur. 10.Ed.
Packing:
25 kg fiber drums on palettes
Usage:
e.g. pharmaceutical industry
