Sample Handling and Laboratory Process

1. Sample Submission & Receipt

  • Clients are responsible for ensuring the sample is packed appropriately for transit.
  • Only samples originating within the United States are accepted.
  • Upon arrival, the sample is logged and inspected for:
    • Proper labeling (e.g., peptide name, concentration)
    • Packaging integrity
    • Physical appearance (e.g., vial condition, cap seal)
  • A sample tracking number and internal batch ID are assigned.

2. Sample Storage & Chain of Custody

  • Samples are stored under controlled conditions based on compound sensitivity (ambient, refrigerated, or frozen).
  • Chain of custody is maintained through barcode-based internal tracking.
  • Only trained personnel have access to test areas.

3. Testing Workflow

Peptide-Specific Assays

  • Identity Confirmation: Confirmed via LC-MS or LC-MS/MS (depending on peptide type) against reference standards.
  • Purity Testing: Performed using HPLC following ICH Q2(R1) for precise purity profiling.
  • Impurity Profiling: High-resolution LC-MS is used to detect process-related and degradation impurities.
  • Quantitative Assays: Calibration against multi-point standards to determine peptide content (mg/mL or %w/w).

Sterility & Endotoxin Testing

  • Sterility Testing: Conducted per USP <71>, with either membrane filtration or direct inoculation, based on sample type.
  • Endotoxin Testing: Quantified using kinetic turbidimetric or chromogenic LAL assay, following USP <85>.

Supplemental & Stability Testing

  • Aggregation Assays, Heavy Metal Screening, Residual Solvent Analysis, and Osmolality Testing are conducted based on requested services.
  • Accelerated pH and Light/Heat Stability testing available per ICH guidelines.

4. Sample Consumption Notice

  • All testing consumes part or all of the submitted sample.
  • Remaining volume (if applicable) can be returned upon request (shipping charges may apply).

5. Reporting & Documentation

  • COAs (Certificate of Analysis) are issued within 3–5 business days after testing completion.
  • Each COA includes:
    • Sample identifier
    • Test parameters, results, and methods
    • Analyst signature and authentication QR or access key

6. Archiving & Record Retention

  • Analytical data is retained for a minimum of 3 years.
  • Retained electronic data is stored on secure servers with restricted access.
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