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GMP Peptide Manufacturing

GL Biochem manufactures GMP grade peptides under strict adherence to  Good Manufacturing Practices.   GMP Peptide Technology Platform Raw material qualification Synthetic method development, validation and scale up Product Purification GMP/GLP analytic method development and validation Release specification design and testing Stability testing (if needed) GMP packaging GMP compliance documentation 　    GMP compliance On-going training In-house Audit Raw material control Analytical method validation and documentation SOPs In process control and batch record Equipments Computers 　    Certificate of Analysis for GMP Peptide 　 Appearance Purity by HPLC Heavy metal by ICP-MS Bioburden or microbial tests Residual organic solvent by GC 　 Solubility Molecular Weight by MS Amino acid analysis Water content Endotoxin Amino acid analysis Peptide Content (nitrogen estimation) Counter Ion Content (% TFA) by IC 　 　     GMP Quality Management