X̄-R Chart — API Assay Concentration
Sixteen release batches assayed in triplicate by HPLC, showing a stable process centred 0.33% above label claim with Cp 1.63 and Cpk 1.52 against the 95–105% compendial specification.
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title "Assay — API concentration, % label claim"
chart xbar-r
unit "% LC"
spec lsl: 95 usl: 105 target: 100
# Three independent HPLC injections per release batch.
subgroup 101.56 100.34 98.34
subgroup 101.37 100.35 101.11
subgroup 99.21 101.11 100.05
subgroup 99.52 100.03 101.07
subgroup 100.98 99.56 100.07
subgroup 98.78 100.83 100.48
subgroup 100.34 100.14 100.00
subgroup 101.42 101.58 98.54
subgroup 101.60 101.79 99.55
subgroup 100.21 100.19 101.56
subgroup 100.50 101.83 99.97
subgroup 98.45 98.53 100.01
subgroup 100.47 99.69 99.20
subgroup 101.94 100.18 99.61
subgroup 100.39 101.49 100.13
subgroup 100.15 100.40 101.29