Extraction Purity
VC-MET-217 — the chromatographic purity of the finished compound — percent target by mass in the recovered product.
Definition
Extraction Purity is the mass fraction of the target compound in the finished, purified product (% w/w), determined by chromatography against impurity peaks. It is the quality gate before a lot is released from the synthesis bay.
Why it matters
Purity gates release and sets the grade of every finished lot. Below the warning band a lot requires re-purification; below critical it is rejected. Purity also feeds the yield reconciliation that detects reactor faults.
Formula
η_ext = A_target / Σ A_all × 100 [% w/w] A_target = integrated target peak area Σ A_all = total integrated area (target + impurities) Reported as mean of duplicate runs; impurity peaks above 0.1 % are itemized on the certificate of analysis.
Inputs
| Input | Detail | Source |
|---|---|---|
| Target peak | Integrated target area | Lab HPLC |
| Impurity peaks | Itemized > 0.1 % area | Lab |
| Mass balance | Recovered vs. charged | CHLORA |
Units & Scale
% w/w to one decimal, per lot, duplicate-mean. Decreasing-is-worse: lower thresholds apply.
Sampling & Source
- Assayed per batch at synthesis-bay release.
- Duplicate runs; impurities > 0.1 % itemized.
- Feeds yield reconciliation with VC-MET-211.
Thresholds
OK
WARN
CRIT
Recent Trend
Zone roll-up, last 14 sampling periods (current 98.9):
Interpretation Guidance
| Band | Reading | Likely Driver | Action |
|---|---|---|---|
| 99.0–99.8 | High grade | Clean extraction | Release at premium grade. |
| 97.0–98.9 | Release | Normal impurity load | Standard release. |
| 95.0–96.9 | Soft | Impurity carryover | Re-purify; inspect reactor. |
| < 95.0 | WARN / CRIT | Process fault | Hold or reject; reconcile. |
Related Metrics
Batch-Normalized Toxin Yield
Reconciliation partner.
VC-MET-219Reactor Conversion Efficiency
Upstream process.
VC-MET-200Alkaloid Concentration
Feedstock potency.
VC-MET-218Compound Stability
Storage quality.
Related SOPs
- Procedure deviation & release — SOP Library.