piocon _{Site-2 Copy CONFIDENTIAL Copy Ne: JNTROL ‘Document Name: RAW MATERIAL SPECIFICATION 02) ‘Subject: 2-4-NITROPHENETHYLAMINE HYDROCHLORIDE (MRB- Page No.:2 of S Document code:QC/SPEC/RM/509 Version No.: 003 i, STANDARDS AND LIMITS AS PER IN-HOUSE SPECIFICATION TESTS LiMITs REFERENCE finch 1. |#DESCRIPTION Joft-white to pale yellow orange powder. rouse in-house 2, SOLUBILITY ISoluble in water. IDENTIFICATION [in-house 4. The retention time of the major peak of the ls. BY HPLC Sample solution corresponds to that of the Standard solution, as obtained in the Assay. b. The IR spectrum of Sample should be concordant with that of the standard lb.BY IR ABSORPTION spectrum and characteristic wave number should be (Vem) 2909810, 152410, 1344e10. 4. FLOSS ON DRYING fot more than 1.0% w/w — =. PERROMATOGRAPHIC [Single maximum unknown impurity NMT:0.50% ~house «_[puriry By HPLC fTotal impurities NMT: 1.0% 6. W*ASSAY BY HPLC fot less than 98.0% a * On dried basis NOTE: Retest shall be done only for the tests with '#" mark. “Electronically prepared and approved dpevment signstuss $5 NptTpUUIE, (CSMVIQCISOPADAT-FILI