Independent identity, purity, endotoxin, and contaminant testing for compounding pharmacies operating under Health Canada GMP standards. Audit-ready COAs in 9–11 business days.
Compounding pharmacies use third-party peptide testing to verify supplier Certificates of Analysis, document identity and purity in line with USP and Ph.Eur. standards for each batch, screen endotoxins and heavy metals for injectable preparations, and maintain defensible quality records for Health Canada inspections. Cert Biohealth Testing Labs provides HPLC purity, MS identity, LAL endotoxin, and ICP-MS contaminant testing from our Toronto laboratory, with results in 9–11 business days.
Mass spectrometry confirms that each peptide matches the labelled sequence and molecular weight before compounding, per USP <1> and <621> principles.
Reverse-phase HPLC quantifies main peak purity and characterizes deletion sequences and synthesis impurities to 0.1% detection.
Quantitative endotoxin testing in EU/mg for injectable peptide preparations per USP <85> and Ph.Eur. 2.6.14.
Trace-level screening for lead, mercury, arsenic, and cadmium per USP <232>/<233> with ppb sensitivity.
GC-MS detection of TFA, DMF, DCM, and acetonitrile remaining from synthesis per ICH Q3C / USP <467>.
Repeat testing programs for ongoing batch-by-batch release with predictable turnaround and preferred pricing for high-volume pharmacies.
Our testing programs are designed to support compounding pharmacies operating under Health Canada’s Food and Drugs Act and associated GMP guidelines, including:
At minimum, every batch should have: (1) identity confirmation by mass spectrometry, (2) purity by HPLC, and (3) endotoxin testing for any injectable preparation. Heavy metal and residual solvent testing is recommended for new suppliers or when the supplier COA does not include these panels. Contact us to design a batch release protocol for your specific peptide portfolio.
Yes. Our COAs include all data elements required by USP general chapters and Ph.Eur. monograph formats, including test description, method reference, result, and specification. We can customize the COA header to include your pharmacy name and batch number upon request.
We can include your pharmacy name as the client of record on the COA, and can white-label reports for some applications. Contact us to discuss your specific documentation requirements.
Standard turnaround is 9–11 business days from sample receipt. Rush 2–3 business day service is available for critical batches. We also offer standing retainer programs for pharmacies that need guaranteed weekly turnaround windows.
Yes. Our laboratory is equipped for multi-sample throughput. Contact us to discuss your monthly batch volume and we will design an appropriate service level agreement with pricing, turnaround guarantees, and dedicated account management.
Tell us about your peptide product line and batch volume. We will return a personalized proposal within one business day.
+1 (416) 000-0000 | info@certbiohealth.ca