Specification. D04

Nortropine ·hydrochloride

8-Azabicyclo-[3,2,1]-octane-3-ol-endo hydrochloride

Interpharma

Molecular Formula: C7H14ClNO
Molecular Weight: 163.65
C.A.S. No.: [14383-51-8]

Description: White to off white crystalline powder.

Tests:
Identification: I.R. spectrum  Ph.Eur 5th<2.2.24>
Loss on dryimg (105 °C): max. 0.5 %  Ph.Eur 5th<2.2.32>
Water (K.F. titration): max. 0.5 %  Ph.Eur 5th<2.5.12>
Sulphated ash: max. 0.1 %  Ph.Eur 5th<2.4.14>
exo-Nortropine hydrochloride (GC): max. 0.5 %  Ph.Eur 5th<2.2.28>
Total sum of all impurities (GC): max 1.0 %  Ph.Eur 5th<2.2.28>
Assay (Acidimetric titration, calculation based on dry substance):
98.0 - 102.0 %  NQ test No.7
Assay (Argentometric titration, calculation based on dry substance): 98.0 - 102.0 %  NQ test No.7
Shelf life: 1 year

*NQ = Norm of Quality

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