ASSAY(HPLC) :NLT 98.0% INDENTIFICATION: IR HPLC RESIDUE ONIGNITION:NMT 0.2% Conforms HEAVY METALS: NMT 20ppm SINGLE…
ASSAY(HPLC) :NLT 98.0%
INDENTIFICATION: IR
HPLC
RESIDUE ON IGNITION:NMT 0.2% Conforms
HEAVY METALS: NMT 20ppm
SINGLE IMPURITY: NMT 0.5%
TOTAL IMPURITY :NMT 1.0%
RESIDUAL SOLVENTS :Conforms with ICH
PHYSICAL CONTROL
DECRIPTION: White to Off-white crystalline
powder
LOSS ON DRYING: NMT 0.5%
STORAGE: Cool and dry
SHELF LIFE: 24 months
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