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Mesalamine / Mesalazine

Human API

Characterised impurities

ImpurityChemical namePharmacopoeia
Impurity “D”3-Aminobenzoic acidBP/EP
Impurity “E”4-amino-2- hydroxybenzoic acid (4-Amino salicylic acidBP/EP
Impurity “F”3-Amino salicylic acidBP/EP
Impurity “G”2,5- dihydroxybenzoic acidBP/EP
Impurity “H”2-hydroxybenzoic acid (Salicylic acid)BP/EP
Impurity “K”Aniline hydrochlorideBP/EP
Impurity “L”2-Chlorobenzoic acidBP/EP
Impurity “M”2-chloro-5- nitrobenzoic acidBP/EP
Impurity “N”2-hydroxy-5- nitrobenzoic acid (5- Nitrosalicylic acid)BP/EP
Impurity “O”Aminobenzenesulfon acid (Sulfanilic acid)BP/EP
OHNBA2-hydroxy-5- nitrobenzoic acid (5- Nitrosalicylic acid)IHT
Impurity “R”2-hydroxy-3- nitrobenzoic acid (3- nitrosalicylic acid)BP/EP
Threo Isomer of PPAM(R)(R,R)-alpha-phenyl- alpha-piperidyl-2- acetamideUSP/U DMF
Threo Isomer of MP.HClThreo I-methyl 2- phenyl-2-(I- piperidin-2-yl) acetate HydrochlorideUSP/U DMF

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