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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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
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use of this information. Any user of this product is responsible for determining the suitability of our products for its particular application.
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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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