Specification
Concerning Product: |
Article number | 130405NLE |
Trade name / designation / denomination | Vitamin B2 5-Natriumphosphat, EP |
CAS number | 130-40-5 |
Other names / synonyms | •RIBOFLAVIN-5?-PHOSPHATE;
•Riboflavin 5'-Phosphate Sodium, Dihydrate, Electrophoresis Grade;
•Riboflavin 5'-Phosphate Sodium, Dihydrate, FCC;
•Riboflavin 5'-Phosphate Sodium, USP;
•Riboflavin 5'-monophosphate sodium salt hydrate;
•Riboflavin 5'-phosphate sodium salt hydrate;
•riboflavin 5'-(sodium hydrogen phosphate);
•sodium [(2S,3R,4R)-5-(7,8-dimethyl-2,4-dioxo-10-benzo[g]pteridinyl)-2,3,4-trihydroxypentyl] hydrogen phosphate; |
EC number | 204-988-6
|
Customs tariff number / CN code / TARIC | 29362300 |
Molecular weight [g / mol] | 478.325631 |
Formula | C17H20N4NaO9P |
Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
Appearance |
|
A Yellow or Organge Yellow Crystalline Powder, Hygroscopic. |
Physical parameter |
Loss on drying |
USP |
≤ 7,5 |
% |
Loss on drying |
EP/BP/E101 (ii) |
≤ 8 |
% |
pH value |
|
1 % Solution 5,0 – 6,5 |
|
Specific Optical Rotation |
E101 (ii) |
38 – 42 |
° |
Specific Optical Rotation |
EP/BP |
38 – 43 |
° |
Specific Optical Rotation |
USP |
37 – 42 |
° |
Solubility |
|
Soluble in water, very slightly soluble in ethanol (96 %) |
Identity |
Assay |
USP |
Riboflavin (o.d.b.) 73 – 79 |
% |
Assay |
EP/BP |
Riboflavin (o.d.b.) 73 – 79 |
% |
Assay |
E101 (ii) |
total coloring matters calculated as C17H20N4NaO9P.2H2O ≥ 95 |
% |
Identification |
EP/BP |
(A): Absorption test: 580 – 640 |
Identification |
EP/BP |
(B) by HPLC test: The principle peak in the chromatogram obtained with the test of solution is similar in position and approximate size to the principle peak in the chŕomatogram obtained with the reference soltion b |
Identification |
USP/EP/BP |
(C) Fluorescence test: The lower layer exhibits yellow fluorescence |
Identification |
|
(D) Reaction of Sodium Salt u. Phosphate: The filtrate gives reaction of sodium and reaction fo phosphate |
Infrared absorbtion spectrometry |
E 101 (ii) |
A375/A267 0,30 – 0,34 |
|
Infrared absorbtion spectrometry |
E 101 (ii) |
A444/A267 0,35 – 0,40 |
|
Impurities |
Heavy Metals (as Pb) |
|
≤ 10 |
mg/kg |
Phosphate (PO4) |
E101 (ii) |
Inorganic ≤ 1,5 |
% |
Phosphate (PO4) |
EP/BP |
Inorganic ≤ 1,0 |
% |
Sulphated ash |
E101 (ii) |
≤ 25 |
% |
Impurity |
EP/BP |
(E): The filtrate is not more intersely coloured than reference solution BY 6 |
Impurity |
|
aromatic amines (as aniline): ≤ 70 |
ppm |
Impurity |
USP |
Lumiflavine: ≤ 0,025 |
absorbance |
Related substances |
|
Free Riboflavin ≤ 6,0 |
% |
Related substances |
|
Riboflavin Diphosphate ≤ 6,0 |
% |
Residual Solvents |
Residual solvents |
|
Methanol: ≤ 0,3 |
% |
Elemental Impurities |
Arsenic (As) |
|
≤ 3 |
mg/kg |
Cadmium (Cd) |
|
≤ 1 |
mg/kg |
Mercury (Hg) |
|
≤ 0,1 |
mg/kg |
Lead (Pb) |
|
≤ 2 |
mg/kg |
Organic volatile impurities |
Org. volat. Imp. Total |
|
as Mentol ≤ 3000 |
ppm |
Microbiological data |
Escherichia Coli. |
|
in 1 gm: Absent |
CFU/g |
Total Plate Count |
|
≤ 1000 |
CFU/gm |
Yeast and Mould |
|
≤ 100 |
CFU/g |
Annotation:
o.d.b. = on dried basis / auf getrockneter Basis
Supplemental information:
Shelf life:
2 years
Storage conditions:
Protect from light and store cool and dry in well-closed original packaging. The temperature should not exceed 25 °C.
Regional origin:
IND
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
|
Waltrop, 03. Jan. 2022
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
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