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Regulatory Guidelines for the Analysis of Therapeutic Peptides and Proteins

revisiting the ratio of bacterial to host cells in humans

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Batch: GF-CJCIPA10/10-B242 Key analytical results include: Ipamorelin Assay Content: 10.26 mg CJC-1295 (MOD GRF 1-29) Assay Content: 11.19 mg Ipamorelin Identification Retention Time: 0.994 CJC-1295 Identification Retention Time: 0.991 Ipamorelin Identification Spectrum: 996 CJC-1295 Identification Spectrum: 993 Purity: high purity confirmed for both peptides Bacterial Endotoxins: below 0.001 EU per mg Total Aerobic Microbial Count: not detected Total Yeast and Mold Count: not detected Independent heavy metal screening confirmed no detectable levels of arsenic, cadmium, cobalt, lead, nickel, mercury or vanadium