Code: 1.00129.1000
4 Table 3: Physical properties of excipient molecules at pH 5 and pH 7 ... This whitepaper examines how combining an amino acid with a ...
per 1KG
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L-α-Aminosuccinic acid , D , (S)-(+)-Aspartic acid , L(+)-2-Amino-1,4-butanedioic acid , H-Asp-OH , L-αlpha-Aminosuccinic acid , (S)-(+)-2-Amino-1,4-butanedioic acid , Asp
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Certifications: Corresponds to Ph. Eur., BP, USP.
