Sample

Compound

Tesamorelin 10 mg

Lot

SA-TSM-2610

Formula

C₂₂₁H₃₆₆N₇₂O₆₇S

Laboratory

Independent lab

Test	Method	Limit	Result
Purity	HPLC	≥ 99.0%	99.62%
Identity	Mass spectrometry	5135.9 ± 1.0 Da	5136.0 Da
Net content	Quantitative HPLC	≥ 10 mg	10.26 mg
Endotoxin	LAL assay	≤ 0.5 EU/mg	0.09 EU/mg
Sterility	Membrane filtration	No growth	No growth
Heavy metals	ICP-MS	≤ 10 ppm total	1.0 ppm
Moisture	Karl Fischer	≤ 8.0%	2.9%