Analytical report evaluation methodology
Depth and scope of analytical testing performed.
| Purity Range | Points |
|---|---|
| ≥99.5% | 4.0 |
| 99.0 – 99.49% | 3.5 |
| 98.0 – 98.99% | 3.0 |
| <98.0% | 2.0 |
| Test | Points | Detection |
|---|---|---|
| MS Confirmation | +3 | Molecular identity |
| Net Peptide Content | +2 | Active compound vs. salts/moisture |
| Sterility | +1 | Microbial contamination |
| Endotoxin (LAL) | +1 | Bacterial endotoxins |
Maximum 11 points → normalized to 10
Correlation between labeled claims and analytical results.
| Element | Points | Criteria |
|---|---|---|
| Product Name | 3 | Compound identification matches label |
| Quantity Accuracy | 0–4 | Asymmetric scoring (see below) |
| Batch ID | 2 | Batch/lot number documented |
| Expiration | 1 | Expiration or retest date present |
| Variance | Points |
|---|---|
| Overfill (any %) | 4 |
| 0% to −5% | 4 |
| −5% to −10% | 2 |
| −10% to −15% | 1 |
| >−15% | 0 |
Documentation and sample handling verification.
| Element | Points |
|---|---|
| Batch ID present | 15 |
| Single vial tested | 15 |
| Two vials tested | 25 |
| Three+ vials tested | 35 |
| Receiving date documented | 15 |
| Tamper-evident seal | 15 |
| Lab custody seal | 20 |
Maximum 115 points → normalized to 10
Data anomaly detection. 73 indicators evaluated.
| Indicator | Penalty |
|---|---|
| Purity >100% | −20 |
| Purity = 100.000% | −8 |
| Round number (.000 or .500) | −3 |
| Email as vendor identifier | −5 |
| Content >150% of label | −8 |
| Score | Classification |
|---|---|
| 95–100 | No anomalies detected |
| 85–94 | Minor flags |
| 70–84 | Review recommended |
| <70 | Multiple flags |
Multiplier applied based on testing source classification.
| Source Type | Modifier |
|---|---|
| Third-party laboratory | 1.0 |
| ISO 17025 accredited | 1.1 |
| In-house / Manufacturer | 0.7 |
| Dual verification (2+ labs) | 1.2 |