Specification
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Concerning Product: |
| Article number | 58082V01 |
| Trade name / designation / denomination | Coffein anhydrat, Pulver EP/USP/JP/IP |
| CAS number | 58-08-2 |
| Other names / synonyms | •1,3,7-trimethylpurine-2,6-dione;
•Caffeine Anhydrous ;
•caffeine; |
| EC number | 200-362-1
|
| EC index number | 613-086-00-5 |
| Customs tariff number / CN code / TARIC | 29393000 |
| Molecular weight [g / mol] | 194.1906 |
| Formula | C8H10N4O2 |
Warning
UN -/-, , |
Harmful if swallowed.
Wash thoroughly after handling. Do no eat, drink or smoke when using this product. Dispose of contents/container in accordance with local/regional/(inter)national regulations. |
| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
Ph. Eur. |
clear and colourless |
| Appearance |
visual |
white crystalline powder |
Physical parameter |
| Acidity/Alkalinity |
Ph.Eur. |
must comply |
|
| Loss on drying |
Ph.Eur. |
≤ 0,5 |
% |
| Melting range |
USP |
235 – 239 |
°C |
Identity |
| Assay |
USP/Ph. Eur. |
in dry sub. Content (HPLC) 98,5 – 101,0 |
% |
| Assay |
Ph. Eur. |
in dry sub. Content (Potentiometric) 98,5 – 101,5 |
% |
| Identification |
Inhouse |
Identity (Raman): In accordance with the reference spectrum |
| Identification |
USP/Ph. Eur. |
Identity HPLC (RT time): RT of the major peak of the sample solution corresponds to that of the calibration solution, as obtained in the assay |
Impurities |
| Residue on ignition |
Ph. Eur., USP |
≤ 0,1 |
% |
| Heavy Metals (as Pb) |
Ph.Eur. |
≤ 10 |
ppm |
| Sulphates (SO4) |
Ph.Eur. |
≤ 240 |
ppm |
| Related substances |
Ph. Eur. |
each (HPCL) ≤ 0,10 |
% [w/w] |
| Related substances |
Ph. Eur. |
sum of all impurities (HPLC) ≤ 0,10 |
% [w/w] |
| Related substances |
Ph. Eur., USP |
Sum of all impurities (HPLC) ≤ 0,1 |
% [w/w] |
| Related substances |
USP/Ph. Eur. |
Unspecified impurities, each (HPCL) ≤ 0,1 |
% [w/w] |
Residual Solvents |
| Residual solvents |
inhouse |
Chloroform ≤ 60 |
ppm |
| Residual solvents |
inhouse |
must comply |
|
Particle size distribution |
| Particles |
inhouse |
< 0.300 mm (No.50) ≥ 95 |
% |
Supplemental information:
Note:
Caffeine anhydrous powder is manufactured according to current GMP requirements .
The manufacturers identification tests replace the Ph. Eur./USP tests based on general notice of Ph. Eur./USP. Sulfates, Heavy metals, Sulphated ash and Residual solvents are not routinely tested. Related substances (HPLC): Any impurity at a level greater than (>0.05%) the reporting threshold is reported with RRT and corresponding quantitative result . If no impurities with relative retention time (RRT) are listed, then no impurities are present above the reporting threshold.
Complies with monographie:
Caffeine anhydrous powder meets the test requirements stipulated in the current version of the following monograph(s): "Caffeine" of Ph.Eur., USP, JP and IP.
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
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Waltrop, 04. Feb. 2025
LF-Basis: (2022-07-12)
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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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