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Specification

Concerning Product:
Article number 165450179CURL
Trade name / designation / denomination Neotam (97-102%), USP
CAS number 165450-17-9
Other names / synonyms•(3R)-3-(3,3-dimethylbutylamino)-4-[[(2R)-1-methoxy-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid; •L-Phenylalanine, N-(3,3-dimethylbutyl)-L-α-aspartyl-, 2-methyl ester;
EC number605-408-8
Molecular weight [g / mol]378.4626
FormulaC20H30N2O5


Parameter Specification Unit

Organoleptic test
Appearance white to off-white Powder

Physical parameter
Loss on drying ≤ 5,0 %
pH value (5g/l solution) 5,0  –  7,0
Specific Optical Rotation (20°C,D)[•dm2/kg] -40,0  –  -43,4 °
Solubility Ethanol & Ethyl Acetate @ 25° C: ≤ 1,26 % (w/w)
Solubility in H2O @ 60° C: ≤ 4,75 % (w/w)

Identity
Assay 97,0  –  102,0 % [w/w]
Infrared absorbtion spectrometry Conforms with standard
Melting Point (identity) 81  –  84 °C

Impurities
Residue on ignition ≤ 0,2 %
Impurity N-[N-(3,3-Dimethylbutyl)-Aspartyl]-L-Phenylatanine ≤ 1,5 %
Related substances ≤ 2,0 % [w/w]

Residual Solvents
Residual solvents neg.

Elemental Impurities
Lead (Pb) ≤ 1 ppm

Microbiological data
Aerobic microorganisms ≤ 250 CFU/g
Coliform bacteria ≤ 10 MPN/g
Salmonella neg.
Staphylococcus Aureus neg.
Yeast and Mould ≤ 100 CFU/g

Supplemental information:

Shelf life: 2 years

Storage conditions: Keep in tightly closed original sealed packing in a cool, clean and dry place, away from direct sunlight and water.

Complies with monographie: USP, GB 29944-2013

Regional origin: CN


Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
Waltrop, 09. Feb. 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 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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