| Product identity | Identity confirmed by at least two orthogonal techniques, such as LC-MS and analytical HPLC. | LC-MS and HPLC reported | HPLC reported; LC-MS not supplied | LC-MS, HPLC, and peptide mapping reported | Review the original test report, method number, chromatograms, and instrument date. |
| Analytical HPLC purity | Common research-grade screening target: not less than 98.0%, unless the product specification states otherwise. | 98.7% to 99.3% across three reported batches | 97.9% to 98.8% across three reported batches | 99.1% to 99.6% across three reported batches | Confirm column type, mobile phase, detection wavelength, integration rules, and whether purity is area percentage. |
| HPLC batch consistency | Small batch-to-batch variation is preferred; a practical screening rule is a range of no more than 1.0 percentage point. | 0.6 percentage-point range | 0.9 percentage-point range | 0.5 percentage-point range | Request chromatograms and complete batch results instead of relying only on a single representative COA. |
| Crude peptide purity | Higher crude purity can reduce downstream purification burden, but it should not replace final API testing. | 78% to 84% | 72% to 80% | 82% to 87% | Compare crude HPLC traces, impurity profiles, and the purification process used for the same sequence. |
| Overall isolated yield | Evaluate yield together with purity, sequence length, protection strategy, and peptide difficulty; no universal pass value applies. | 31% to 38% | 26% to 35% | 34% to 41% | Ask for the calculation basis, starting resin loading, actual isolated mass, and number of manufacturing batches. |
| Batch record availability | At least three recent, product-specific batches should be available for technical review. | Three batch COAs and summary records available | One COA available; additional batch records pending | Three batch COAs plus deviation summary available | Check batch numbers, manufacturing dates, release dates, retest dates, and document revision control. |
| Residual solvents | Results should be reported against the applicable ICH Q3C category and product-specific limits. | Reported with specification limits | Not reported on the supplied COA | Reported with specification limits | Request a solvent panel, analytical method, reporting limit, and actual result for each relevant solvent. |
| Water content | Method and limit should be defined for the specific peptide and salt or counter-ion form. | Karl Fischer result reported | Loss-on-drying result reported | Karl Fischer result reported | Do not directly compare Karl Fischer and loss-on-drying results without considering method differences. |
| Counter-ion and salt form | The stated form must match the ordered material and the amount used in assay calculations. | TFA salt clearly identified | Salt form stated but assay basis unclear | Acetate salt and assay basis identified | Verify molecular weight, counter-ion content, assay correction, and conversion factors. |
| Endotoxin testing | Required when the intended use is sensitive to endotoxin; limit must be agreed before ordering. | Testing available on request | Not included in standard release package | Result included for the tested lot | Confirm sample preparation, dilution, assay sensitivity, result units, and product-specific acceptance criteria. |
| Stability and retest data | Real-time or accelerated stability data should support the proposed retest period and storage condition. | Accelerated data available | No product-specific stability data supplied | Real-time and accelerated data available | Review storage temperature, packaging configuration, sampling intervals, and degradation markers. |
| Quality-system evidence | Documented quality procedures, controlled specifications, deviation handling, and change control are preferred. | Quality-system questionnaire completed | Basic quality documents supplied | Quality-system questionnaire and audit package supplied | Request audit responses, change-control policy, OOS procedure, and data-integrity statement. |
| Overall screening result | Prioritize transparent, reproducible batch evidence over a single high purity number. | Strong technical candidate | Requires additional documentation | Strong technical candidate | Use a risk-based qualification process and confirm all critical attributes with current product-specific records. |