The products will be fully characterized with HNMR/CNMR, IR/UV, LC-MS and HPLC analyses. CNMR is available as requested at free of charge. Endotoxin level will be examined for GMP grade.
We use Impurity standard(s), combining with NMR/IR/UV/MS & Titration (to determine inorganic impurities) to determine the percentage and the identity.
For GMP grade, master documents, including synthesis (Three steps, in GMP), purification and characterization, aliquoting & freeze drying, which records the whole process of GMP production under US FDA inspected GMP facility will be provided.
May support CMC file documentation, Production & Quantity documentation, please request a quote from us.
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