Specification
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Concerning Product: |
| Article number | 58559P50 |
| Trade name / designation / denomination | Theophylline anhydrous,powder 50kg
Theophyllin wasserfrei, Pulver 50kg |
| CAS number | 58-55-9 |
| Other names / synonyms | •1,3-dimethyl-7H-purine-2,6-dione;
•theophylline; |
| EC number | 200-385-7 |
| Customs tariff number / CN code / TARIC | 29395900 |
| Molecular weight [g / mol] | 180,17 |
| Formula | C7H8N4O2 |
Danger
2811, 6.1 (Giftige Stoffe), III |
Toxic if swallowed.
Wash thoroughly after handling. Do no eat, drink or smoke when using this product. IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. Rinse mouth. |
| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
Ph.Eur. |
complies |
|
| Colour |
visual |
white |
|
Physical parameter |
| Acidity/Alkalinity |
Ph.Eur. |
complies |
|
| Form |
visual |
crystalline powder |
| Loss on drying |
Ph.Eur. |
≤ 0,5 |
% |
| Melting range |
USP |
271 – 274 |
°C |
Identity |
| Assay |
Ph.Eur., USP |
99,5 – 100,5 |
% |
| Identification |
inhouse |
HPLC: conforms to the chromatography of the standard preparation |
| Identification |
inhouse |
RAMAN: conforms to reference spectrum |
Impurities |
| Heavy Metals (as Pb) |
Ph.Eur. |
≤ 20 |
ppm |
| Sulphated ash |
Ph.Eur., USP |
≤ 0,1 |
% |
| Related substances |
Ph.Eur., USP |
each other impurity: ≤ 0,10 |
% [w/w] |
| Related substances |
Ph.Eur., USP |
Impurity A: ≤ 0,10 |
% [w/w] |
| Related substances |
Ph.Eur., USP |
Impurity B: ≤ 0,10 |
% [w/w] |
| Related substances |
Ph.Eur., USP |
Impurity C: ≤ 0,10 |
% [w/w] |
| Related substances |
Ph.Eur., USP |
Impurity D: ≤ 0,10 |
% [w/w] |
| Related substances |
Ph.Eur., USP |
in sum: ≤ 0,50 |
% [w/w] |
Particle size distribution |
| Particles |
|
300 µm ≥ 97 |
% |
Supplemental information:
Shelf life:
4 years
Note:
The product is manufactured according to current GMP requirements.
Complies with monographie:
Tests are based on Ph.Eur. ＆ USP. Identification tests are inhouse.
Regional origin:
D
Conclusion:
The product meets the requirements of current monograph of Ph.Eur., USP and JP.
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
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Waltrop, 12. Feb. 2020
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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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