CAT. No. | CP-G3008 |
---|---|
CAS. No. | NA |
Mol. F. | C21H35NO11 |
Mol. Wt. | 477.51 |
Stock Status | Custom Synthesis |
Gabapentine Lactose Adduct is an impurity that forms when Gabapentin interacts with lactose under certain conditions during processing or storage.
Regulatory authorities require monitoring of impurities like Gabapentine Lactose Adduct to ensure the quality and safety of Gabapentin products.
It forms due to interactions between Gabapentin and lactose, particularly during synthesis or extended storage.
Proper storage and careful control of formulation components can help minimize its formation.
GC-MS, LC-MS, and HPLC-MS are commonly used to detect and quantify Gabapentine Lactose Adduct accurately.
Chemicea provides COA, H-NMR, MASS, HPLC, and TGA reports as standard, with additional reports like CNMR, IR, UV, DEPT, Water content, and CHNS available upon request.
Yes, Chemicea’s documentation meets standards required by major regulatory bodies including USFDA, EMA, ANVISA, and PMDA.
It is stable for shipping at room temperature, with specific storage guidelines provided in the COA.
Yes, Chemicea offers both standard and customized pack sizes to meet specific client needs.
Chemicea supplies Gabapentine Lactose Adduct as a reference standard, aiding regulatory compliance, method validation, and impurity profiling.