Specification
|
Concerning Product: |
| Article number | 25322683TPEUG3 |
| Trade name / designation / denomination | Polyethylenglycol 300, EP/USP, GMP |
| 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 |
visual |
(25% in H2O) clear |
| Colour |
EN 1557 |
(25% in H2O) ≤ 15 |
Hazen |
Physical parameter |
| Acidity/Alkalinity |
Ph. Eur. |
≤ 0,1 |
|
| Form |
|
liquid |
|
| Loss on drying |
DIN 51777 |
≤ 1,00 |
% |
| Molar mass |
of OH value |
285 – 315 |
g/mol |
| OH-value |
DIN EN OSO 4629 |
356 – 394 |
mgKOH/g |
| pH value |
USP-NF |
(5% in H2O) 4,5 – 7,0 |
| Reducing substances |
Ph.Eur. |
corresponding |
|
| Viscosity |
USP-NF |
@ 98.9°C: 5,4 – 6,4 |
mm²/s |
| Viscosity |
DIN 51562 |
@ 20 C°: 88 – 96 |
mPa s |
Impurities |
| Dioxins |
Head-Space GC |
≤ 1 |
ppm |
| Sulphated ash |
Ph. Eur. |
≤ 0,1 |
% |
| Impurity |
Head-Space GC |
Ethylene oxide: ≤ 1 |
ppm |
| Impurity |
Ph. Eur. |
Formaldehyde: |
% |
| Related substances |
Ph. Eur. |
Ethylen- ＋ Diethylenglycol: ≤ 0,20 |
% |
Supplemental information:
Shelf life:
2 years
Note:
Formaldehyde content may increase during storage.
ICH-Guideline for Residual Solvents incl. Annex I (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 (1.4-Dioxane max. 1 ppm, Ethylene glycol max. 500 ppm). Annex I of the above mentioned ICH guideline is not applicable.
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.
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.
Complies with monographie:
The product comply with all specification requirements of the current version of the Ph. Eur. and USP-NF. Manufactured according to IPEC-GMP (Excipients).
Regional origin:
D
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
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Waltrop, 01. Jul. 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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