Chemische Werke Hommel GmbH & Co. KG  

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Specification

Concerning Product:
Article number 562107MPEG
Trade name / designation / denomination Doxylaminsuccinat
CAS number 562-10-7
Other names / synonyms•Doxylamine succinate; •butanedioic acid; N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]ethanamine; •doxylamine hydrogen succinate;
EC number209-228-7
Customs tariff number / CN code / TARIC29333999
Molecular weight [g / mol]388.45742
FormulaC21H28N2O5
Warning
Harmful if swallowed. Causes skin irritation. Causes serious eye irritation. May cause respiratory irritation.
Wash thoroughly after handling. Wear protective gloves/protective clothing/eye protection/face protection.


Parameter Test Method Specification Unit

Organoleptic test
Appearance of solution visual clear and colourless
Colour visual white or almost white

Physical parameter
Form visual powder
Water content KF ≤ 0,5 %

Identity
Assay Titration 99,0  –  101,0 %
Infrared absorbtion spectrometry IR conform to the reference

Impurities
Sulphated ash ≤ 0,1 %
Impurity Related Substances (CG) (C): ≤ 0,5 %
Impurity Related Substances (CG) any: ≤ 0,1 %
Impurity Related Substances (CG) total: ≤ 0,7 %

Residual Solvents
Isopropyalcohol Residual Solvents ≤ 5000 l/hlpa
Toluene Residual Solvents ≤ 450 ppm

Regulatory information:

Registration status: This batch has been manufactured, packaged and tested in accordance with EU GMP Guideline Volume 4 Part II (ICH Q7).


Supplemental information:

Shelf life: 5 years

Complies with monographie: Ph.Eur.

Regional origin: ES


Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
Waltrop, 19. Apr. 2023
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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