Specification
|
Concerning Product: |
| Article number | 58855BN |
| Trade name / designation / denomination | D-Biotin |
| CAS number | 58-85-5 |
| Other names / synonyms | •5-(2-oxo-1,3,3a,4,6,6a-hexahydrothieno[3,4-d]imidazol-4-yl)pentanoic acid;
•Biotine 2%;
•Biotine pure;
•biotin;
•vitamin H; |
| EC number | 200-399-3 |
| Customs tariff number / CN code / TARIC | 29362900 |
| Molecular weight [g / mol] | 244.31064 |
| Formula | C10H16N2O3S |
| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
1% in 0,1N NaOH |
clear and colourless |
| Appearance |
|
white crystalline powder |
Physical parameter |
| Loss on drying |
|
≤ 1,0 |
% |
| Specific Optical Rotation |
on dry material |
89 – 93 |
° |
| Melting range |
with decomposition |
229 – 232 |
°C |
| Solubility |
|
Very slightliy soluble in water and in ethanol, practically insoluble in organic solvents |
Identity |
| Assay |
|
97,5 – 101 |
% |
| Identification |
|
complies |
|
Impurities |
| Heavy Metals (as Pb) |
|
≤ 10 |
ppm |
| Sulphated ash |
|
≤ 0,1 |
% |
| Related substances |
|
conforms to Ph. Eur requirements |
% [w/w] |
Residual Solvents |
| Residual solvents |
|
Toluene ≤ 890 |
ppm |
Elemental Impurities |
| Arsenic (As) |
|
≤ 2 |
ppm |
| Cadmium (Cd) |
|
≤ 1 |
ppm |
| Mercury (Hg) |
|
≤ 0,1 |
ppm |
| Lead (Pb) |
|
≤ 2 |
ppm |
Organic volatile impurities |
| Org. volat. Imp. Total |
|
comforms to USP requirements |
Microbiological data |
| Coliform bacteria |
|
negativ |
|
| Escherichia Coli. |
|
Negative |
CFU/g |
| Salmonella |
|
Negative |
|
| Staphylococcus Aureus |
|
Negative |
|
| Total Plate Count |
|
≤ 99 |
CFU/g |
| Yeast and Mould |
|
≤ 49 |
CFU/g |
Supplemental information:
Shelf life:
36 month
Storage conditions:
Protect from light and store cool and dry in well-closed original packaging. The temperature should not exceed 25 °C.
Complies with monographie:
USP, FCC, Ph. Eur
Regional origin:
CN
Usage:
Pharma, food, feed and veterinary
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
|
Waltrop, 12. May. 2020
|
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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