Monday, 02 October 2023
| 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 |
