Testing panels
| Panel | Scope | Methods |
|---|---|---|
| Peptides | Identity confirmation and purity quantitation for synthetic peptides. BPC-157, TB-500, GHK-Cu, PT-141, Selank, Semax, and custom sequences. Each certificate includes chromatographic purity and mass confirmation. | RP-HPLC LC-MS |
| GLP-1 analogues | Semaglutide, tirzepatide, liraglutide, and related GLP-1 receptor agonists. Identity verification by molecular weight and purity profiling. | RP-HPLC LC-MS |
| HGH & growth factors | Human growth hormone (191aa), IGF-1, and related growth factors. Purity by RP-HPLC and aggregate screening by size-exclusion chromatography. | SEC RP-HPLC |
| Purity & identity | General-purpose chromatographic purity assessment and mass-spectrometric identity confirmation for research compounds not covered by a specific panel. | RP-HPLC LC-MS |
| Heavy metals | Elemental impurity screening per USP <232>/<233> guidelines. Quantitation of Pb, As, Hg, and Cd by inductively coupled plasma mass spectrometry. | ICP-MS |
| Endotoxin & sterility | Bacterial endotoxin testing by kinetic turbidimetric LAL assay per USP <85>. Microbial limit testing per USP <61>/<62>. | LAL kinetic |
Reference standards
| Standard | Description |
|---|---|
| USP <621> | Chromatographic system suitability for RP-HPLC and SEC purity/identity methods. |
| USP <232>/<233> | Elemental impurity limits and ICP-MS procedures for oral and parenteral products. |
| USP <85> | Bacterial endotoxin testing by kinetic turbidimetric LAL assay. |
| USP <61>/<62> | Microbial enumeration and tests for specified organisms. |
Instrumentation
| Instrument | Application |
|---|---|
| Reversed-phase HPLC | C18 column chromatography with UV/PDA detection for purity profiling and quantitation. |
| LC-MS | Liquid chromatography coupled with mass spectrometry for molecular weight confirmation and identity. |
| ICP-MS | Inductively coupled plasma mass spectrometry for trace-level elemental impurity detection. |
| Size-exclusion HPLC | SEC for aggregate and fragment analysis in protein and peptide samples. |
| LAL kinetic turbidimetric | Limulus amebocyte lysate assay for bacterial endotoxin quantitation. |
| Karl Fischer titration | Moisture content determination for lyophilized and powder samples. |