Specification
|
Concerning Product: |
| Article number | 25322683TP3350 |
| Trade name / designation / denomination | Polyethylenglycol 3350 P |
| CAS number | 25322-68-3 |
| Other names / synonyms | •Macrogol;
•Poly(ethylene oxide);
•Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated;
•Polyethylene glycol;
•Polyethylene glycol 1500;
•Polyethylene glycol 300;
•Polyethylene glycol 4000;
•Polyethylene glycol 6000;
•ethane-1,2-diol; |
| EC number | 500-038-2
|
| Customs tariff number / CN code / TARIC | 39072011 |
| Molecular weight [g / mol] | 62.06784 |
| Formula | (C2H6O2)n |
| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
25% in water |
clear |
|
| Appearance |
@20°C |
powder |
|
| Colour |
25% a.i. in water |
≤ 30 |
|
Physical parameter |
| Acidity/Alkalinity |
|
ml 0.1M NaOH/5g; titrimetric ≤ 0,1 |
| Loss on drying |
Karl-Fischer |
≤ 1,00 |
% |
| Molar mass |
HPLC |
3015 – 3685 |
g/mol |
| Molar mass |
calculated of OH value |
3050 – 3685 |
g/mol |
| OH-value |
|
30,0 – 37,0 |
mgKOH/g |
| pH value |
|
5% in H2O 4,5 – 7,5 |
|
| Reducing substances |
|
complies |
|
| Solidification range |
|
53,0 – 57,0 |
°C |
| Viscosity |
|
@ 98.9°C: 76 – 110 |
mm2/s |
| Viscosity |
|
25% in H2O 85 – 105 |
mPa s |
Identity |
| Assay |
|
HPLC: 97,0 – 103 |
% |
| Assay |
Polydispersity |
HPLC: 90 – 110 |
% |
| Identification |
|
IR/HPLC complies |
Impurities |
| Residue on ignition |
|
≤ 0,1 |
% |
| Sulphated ash |
|
≤ 0,1 |
% |
| Impurity |
Ethyleneglycol |
≤ 0,062 |
% |
| Impurity |
Ethylene- and diethylene glycol |
≤ 0,2 |
% |
| Impurity |
Dioxane content Head-Space GC |
≤ 1,00 |
ppm |
| Impurity |
Ethylene oxide Head-Space GC |
≤ 1,00 |
ppm |
| Impurity |
HPLC |
Formaldehyde ≤ 15 |
ppm |
| Impurity |
HPLC |
Sum Acetaldehyde and Formaldehyde ≤ 200 |
ppm |
Annotation:
ICH-Guideline for Residual Solvents (ICH/Q3C): Ethylene oxide is used as
a monomer for the production of the product. It is specified to have a
residual level of 1 ppm in the final product.
Only class 2 solvents
1.4-Dioxane and Ethylene glycol are likely to be present, due to the
nature of the production process; all are below the Option 1 limit.
Annex I of the above mentioned ICH guideline is not applicable.
ICH-Richtlinie für Restlösemittel (ICH/Q3C): Ethylenoxid wird als
Monomer für die Herstellung des Produkts verwendet. Es wird ein
Restgehalt von 1 ppm im Endprodukt angegeben.
Aufgrund der Natur
des Produktionsprozesses sind wahrscheinlich nur Lösungsmittel der
Klasse 2, 1,4-Dioxan und Ethylenglykol, vorhanden; alle liegen unter dem
Limit von Option 1. Anhang I der oben genannten ICH-Guideline ist nicht
anwendbar.
Metal impurities according to ICH Q3D "Metal impurities" have
been evaluated for the Polyglykols in a risk assessment. A separate
statement on ICH Q3D metal impurity limits is available on request.
Formaldehyde and Acetaldehyde content may increase during storage.
Sulphated Ash, Residue on ignition, Reducing Substances and
Metal impurities according to ICH Q3D are tested in a skipped testing
procedure. All other testing results given on the CoA are determined on
every single batch or its precursor batch. Viscosity at 98.9°C is
correlated from Viscosity at 20°C of 50% solution.
Supplemental information:
Complies with monographie:
EP, USP-NF, JP
Regional origin:
D
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
|
Waltrop, 24. Aug. 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
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
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the buyer of our product.
Nothing included in this information waives any of our General
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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
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