Pregabalin Lactose Conjugate Impurity
| CAS No. | : 466678-44-4 |
| Mol F. | : C20H35NO11 |
| Mol W. | : 465.49 |
| Cat No. | : SA24847 |
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Description
| Product Name | Pregabalin Lactose Conjugate Impurity |
| Synonyms | Pregabalin Lactam (S)-Isomer Lactose Adduct
(4R)-4-isobutyl-5-(((2R, 3R, 4R, 5R)-2, 3, 5-trihydroxy-4-(((2S, 3R, 4S, 5R, 6R)-3, 4, 5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydro-2H-pyran-2-yl)methyl)pyrrolidin-2-one |
| Related API | Pregabalin |
| Category | Impurities |
Pregabalin Lactose Conjugate Impurity product with CAS: 466678-44-4 is also known as Pregabalin Lactam (S)-Isomer Lactose Adduct; (4R)-4-isobutyl-5-(((2R, 3R, 4R, 5R)-2, 3, 5-trihydroxy-4-(((2S, 3R, 4S, 5R, 6R)-3, 4, 5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydro-2H-pyran-2-yl)methyl)pyrrolidin-2-one; . This product can be used as a working standard or secondary reference standard (additional internal validation as per respective FDA regulations/guidelines may require). Pregabalin Lactose Conjugate Impurity is used in Pregabalin impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines during commercial production of Pregabalin and its related formulations. Moreover, (4R)-4-isobutyl-5-(((2R, 3R, 4R, 5R)-2, 3, 5-trihydroxy-4-(((2S, 3R, 4S, 5R, 6R)-3, 4, 5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydro-2H-pyran-2-yl)methyl)pyrrolidin-2-one is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation. Please also find out other impurities of Pregabalin developed in our R&D.
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