RPL Peptide
Official Technical Documentation
HPLC Library
HPLC Analysis — Tirzepatide¶
Analytical Method¶
| Parameter | Specification |
|---|---|
| Method | Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) |
| Detection Wavelength | 214 nm |
| Column | C18, 4.6 × 250 mm, 5 μm |
| Mobile Phase A | 0.1% TFA in Water |
| Mobile Phase B | 0.1% TFA in Acetonitrile |
| Gradient | Linear gradient 20–60% B over 30 minutes |
| Flow Rate | 1.0 mL/min |
| Injection Volume | 20 μL |
| Column Temperature | 25°C |
| Run Time | 40 minutes |
Typical Chromatographic Data¶
| Parameter | Specification |
|---|---|
| Retention Time | [Minutes] |
| Main Peak Purity | ≥99.0% |
| Theoretical Plates | ≥10,000 |
| Tailing Factor | 0.8–1.5 |
| Relative Retention Time | [RRT] |
Acceptance Criteria¶
| Parameter | Limit |
|---|---|
| Main Peak Purity | ≥99.0% |
| Single Impurity | ≤0.5% |
| Total Impurities | ≤1.0% |
Representative Chromatogram¶
[HPLC chromatogram image would be inserted here for each batch]
Batch-Specific Data¶
| Batch Number | Purity (%) | Retention Time (min) | Impurity Profile |
|---|---|---|---|
| [Batch-001] | — | — | — |
Notes¶
- HPLC analysis is performed on every batch prior to release
- Chromatograms are archived and available upon request
- All testing follows validated analytical procedures per ICH guidelines
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Official Technical Documentation
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