Saturday, 15 August 2020

Alternate Text

IMPURITIES

NAME OF IMPURITIES ADDITIONAL DESCRIPTION API CAS#
(2S)2-{17-(but-3-enyl)-4,5 α-epoxy-3-hydroxy-6-methoxy-α,
14-ethano-14α-morphinan-7 α-y1}-3,3-dimethylbutan-2ol.
Buprenorphine Impurity-A USP or EP Impurity-A Buprenorphine 457071-73-7
4,5α-epoxy-7α-[(1s)-1-hydroxy-1,2,2-trimethylpropyl]-3,6-dimethoxy-6α,
14-ethano-14α-morphinan-17-corbonitrile;N-Cyano-3-0-methyl Norbuprenorphine
Bupernorphine EP Impurity-C Buprenorphine 16614-60-1
[5α,7α(s)]-17-(cyclopropylmethyl)-α-(1,1-dimethyl)-4,5-epoxy-18,
19-dihydro-3.6-dimethoxy-α-methyl-6,14-ethenomonorphinan-7-methonal
Bupernorphine EP Impurity-D Buprenorphine 16524-65-5
(2s)-2-{17-butyl-4,5 α-epoxy-3-hydroxy-6 α,
14-ethano-14α-morphinan-7α-yl}-3,3-dimethylbutan-2ol
Bupernorphine EP Impurity-H Buprenorphine 90387-35-2
(2s)-2-{17-(Cyclopropyl methyl)-4,5 α-epoxy-3-hydroxy-6-methoxy-6-α,
14-etheno-14α-morphinan-7α-yl}-3,3-dimethylburan-2ol
Bupernorphine EP Impurity-J or USP Impurity-J Buprenorphine 155203-05-7
5-Nitro isopthalic acid Impurity-A USP (or) As per EP impurity-O Glycopyrronium bromide 618-882
Glocopyrrolate base Glycopyrrolate impurity-B as per USP Glycopyrronium bromide 13118-10-0
Cyclopentylmandelic and entiomer Glycopyrrolate impurity-C as per USP Glycopyrronium bromide 427-49-6
Methyl(2RS)-2-cyclopentyl-2-hydroxy-2-phenyl acetate and enantiomer Glycopyrrolate impurity-L as per EP Glycopyrronium bromide 19833-96-6
4-(diethylamino)but-2-ynyl 2-hydroxy-2,2-diphenyl acetate
(diphenyl analogue of Oxybutynin)
Oxybutynin impurity-B as per EP Oxybutynin Cloride 14943-53-4
(RS)-2-cyclohexyl-2-hydroxy-2-phenyl acetic acid(or)
phenylcyclohexylglycolic acid)
Oxybutynin impurity-D as per EP and impurity-A as per USP Oxybutynin Cloride 4335-77-7
α-cyclohexyl-α-hydroxybenzeneacetic acid Methyl Ester Oxybutynin impurity-B as per USP Oxybutynin Cloride 10399-13-0
3-hydroxy-1-methyl-1-Asoniabicyclo[2.2.2] octane Bromide Clidinium related compound A Clidinium Bromide 76201-95-1