Specification
|
Concerning Product: |
| Article number | 6004246SPE |
| Trade name / designation / denomination | Cetylpyridiniumchlorid monohyd, Ph. EUR. |
| CAS number | 6004-24-6 |
| Other names / synonyms | •1-hexadecylpyridin-1-ium chloride hydrate; |
| EC number | 204-593-9 |
| Customs tariff number / CN code / TARIC | 29333999 |
| Molecular weight [g / mol] | 358.0014 |
| Formula | C21H40ClNO |
Danger
2811, 6.1, II |
Toxic if swallowed. Causes skin irritation. Causes serious eye damage. Causes serious eye irritation. Fatal if inhaled. May cause respiratory irritation. Very toxic to aquatic life. Very toxic to aquatic life with long lasting effects.
Do not breathe dust/fume/gas/mist/vapours/spray. Avoid release to the environment. Wear respiratory protection. Dispose of contents/container in accordance with local/regional/(inter)national regulations. |
| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
Ph.Eur. |
Solution S should not be more opalescent than reference Suspension II and is colourless. |
| Appearance |
Ph. Eur. |
A white powder, slightly soapy to the touch. |
Physical parameter |
| Acidity/Alkalinity |
Ph. Eur. |
The quantity of 0.02 M sodium hydroxide that is required to change the colour of the indicator shuld be ≤ 2,5 |
ml |
| Loss on drying |
Ph.Eur. (2.5.12) |
4,5 – 5,5 |
% w/w |
| Solubility |
Ph. Eur. |
Soluble in water and in alcohol. An aqueous solution froths copiously when shaken. |
Identity |
| Assay |
Ph. Eur. |
96,0 – 101,0 |
% w/w |
| Identification |
Ph.Eur. (2.2.25) |
Test A. Ultraviolet absorbtion spectrumetry: Examine between 240 nm and 300 nm, the solution shows an absorbtion maximum at 259 nm and 2 shoulders at about 254 nm and at about 265 nm. The specific absorbance at the maximum is 126 to 134, calculated with reference to the anhydrous substance. |
| Identification |
Ph.Eur. (2.2.24) |
Test B. Infrared absorbtion spectrometry: IR absorption spectrum should be concordant with Ph.Eur. Reference spectrum. |
| Identification |
Ph.Eur. |
Test C. Colour developement: The Chloroform layer becomes blue. |
| Identification |
Ph.Eur. (2.3.1) |
Test D. Chlorides: Solution S should give test for chlorides. |
Impurities |
| Residual solvents |
GC-HS |
(1.) Pyridine: ≤ 200 |
ppm |
| Residual solvents |
GC-HS |
(2.) Ethyl acetate: ≤ 5000 |
ppm |
| Residual solvents |
GC-HS |
(3.) Methyl ethyl ketone: ≤ 5000 |
ppm |
| Sulphated ash |
Ph.Eur. (2.4.14) |
≤ 0,2 |
% w/w |
| Impurity |
Ph. Eur. (potentiometric titration) |
Amines and amine salts: ≤ 5,0 |
ml |
Microbiological data |
| Aerobic microorganisms |
|
≤ 1000 |
CFU/g |
| Yeast and Mould |
|
≤ 100 |
CFU/g |
Supplemental information:
Shelf life:
≥ 58 Mon.
Storage conditions:
under warehouse conditions in closed original packaging
Packing:
HDPE drums, inner double lined with LLDPE bags, 250 gauge.
Regional origin:
IND
Conclusion:
The product comlies as per EP 8.3 specification.
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
|
Waltrop, 05. Aug. 2019
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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
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