Comprehensive screening for heavy metals (ICP-MS), residual solvents (GC-MS), and elemental impurities in research and pharmaceutical-grade peptides. USP and Ph.Eur. compliant methods.
Peptide contaminant testing covers two main categories: (1) heavy metals by ICP-MS — lead, mercury, arsenic, and cadmium to USP <232>/<233> and Ph.Eur. 5.20 limits; and (2) residual solvents by GC-MS — TFA, DCM, DMF, acetonitrile, and other Class 1/2/3 solvents retained from synthesis. Cert Biohealth Testing Labs provides both panels individually or as a combined package with results in 9–11 business days.
Inductively coupled plasma mass spectrometry for trace-level detection of lead (Pb), mercury (Hg), arsenic (As), and cadmium (Cd) per USP <232>/<233> and Health Canada guidelines.
Gas chromatography–mass spectrometry for detection of Class 1, 2, and 3 residual solvents including TFA, DCM, DMF, and acetonitrile retained from SPPS synthesis.
Expanded elemental impurity testing covering all ICH Q3D Class 1 and 2A elements including platinum-group metals from catalytic processes.
Targeted trifluoroacetic acid (TFA) quantification for research and injectable peptides, commonly retained from HPLC purification steps.
| Contaminant | Method | Detection Limit | USP <232> Oral Limit | USP <232> Parenteral Limit |
|---|---|---|---|---|
| Lead (Pb) | ICP-MS | 0.1 ppb | 5 µg/day | 5 µg/day |
| Mercury (Hg) | ICP-MS | 0.1 ppb | 30 µg/day | 3 µg/day |
| Arsenic (As) | ICP-MS | 0.1 ppb | 15 µg/day | 15 µg/day |
| Cadmium (Cd) | ICP-MS | 0.1 ppb | 5 µg/day | 5 µg/day |
| TFA | GC-MS | 10 ppm | Class 2 evaluation | Class 2 evaluation |
| DCM | GC-MS | 5 ppm | 600 ppm (Class 2) | 600 ppm (Class 2) |
| DMF | GC-MS | 5 ppm | 880 ppm (Class 2) | 880 ppm (Class 2) |
Heavy metals can be introduced during solid-phase peptide synthesis through contaminated reagents, resin impurities, or purification equipment. Palladium and other platinum-group metals may also be introduced from catalytic deprotection steps used in some synthetic routes.
Trifluoroacetic acid (TFA) is the most common residual solvent in synthetic peptides as it is widely used for Fmoc deprotection and RP-HPLC purification. DCM (methylene chloride), DMF (dimethylformamide), and acetonitrile are also frequently detected. TFA is particularly important to screen as it can interfere with biological assays and cell-based studies.
Canadian compounding pharmacies and manufacturers typically follow USP <232> (Elemental Impurities–Limits) and USP <233> (Elemental Impurities–Procedures) for heavy metals, and ICH Q3C for residual solvents. Health Canada also references Ph.Eur. 5.20 for elemental impurities. We provide data in formats compliant with all of these standards.
Typically 5–20 mg for a combined heavy metal and residual solvent panel. ICP-MS requires sample digestion, which is destructive, so ensure you have sufficient material before shipping.
ICP-MS heavy metal and GC-MS residual solvent screening compliant with USP <232>, ICH Q3C, and Health Canada guidelines.
+1 (416) 000-0000 | info@certbiohealth.ca