Process for drying bendamustine hydrochloride monohydrate
AssigneeJohnson Matthey PLC
InventorsXing Fu, Jeremy Clinton Wilt
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Abstract
Wet bendamustine hydrochloride monohydrate may be dried by a two stage process wherein rapid drying is first carried out to provide a partially dried product, which is then further dried using an inert gas of controlled relative humidity to yield dry bendamustine hydrochloride monohydrate.
Claims23
The method of obtaining dry bendamustine hydrochloride monohydrate, comprising the steps of:
- a) drying wet bendamustine hydrochloride monohydrate under conditions effective to yield partially dried bendamustine hydrochloride monohydrate having a moisture content of about 4.4% to about 19%;
- and
- b) contacting the partially dried bendamustine hydrochloride monohydrate with an inert gas of controlled relative humidity to yield dry bendamustine hydrochloride monohydrate.
Dry bendamustine hydrochloride monohydrate, containing less than 0.15%, as determined by HPLC area %, of monohydroxy-bendamustine.
Dry bendamustine hydrochloride monohydrate, substantially free of any other physical form of bendamustine hydrochloride.
Dry bendamustine hydrochloride monohydrate, substantially free of anhydrous bendamustine hydrochloride.
Dependencies are inferred from the claim text.