USP <232> <233>

prepFAST for pharmaceutical laboratories

Automated elemental impurity analysis for USP <232> & <233>

The prepFAST inline autodilution system, paired with ICP-OES or ICP-MS, fully automates the USP <233> method — from calibration through spike recovery — with no manual dilutions.

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Pharmaceutical products tested under USP 232: oral liquids, powders, tablets, inhalation and injectable solutions

What prepFAST automates

  • Dilutes a single stock standard to build linear calibration curves.
  • Dilutes samples to the appropriate total dissolved solids.
  • Spikes samples at user-defined J values for QC and validation.

Select any figure below to enlarge it.

About USP <232> and <233>

USP Chapter <232> defines a target (J) value as a function of the permitted daily exposure (PDE, µg/day) and a drug’s maximum daily dose (g/day).

Chapter <233> sets out the procedures for determining elemental impurities by ICP-OES and ICP-MS. It requires a calibration curve and QC validation — spike recovery, accuracy, precision and stability — all based on the target J value.

Step 1

Autocalibration

Build every USP calibration curve inline from a single stock standard.

Conventional USP 233 calibration with 8 manual standards compared with prepFAST autocalibration from one standard
Calibrate for multiple products from the same standard
Arsenic J calibration at a 20 g daily dose, 0.5J to 2J, with R squared of 0.999999
Linear calibrations with less contamination and no manual dilution error
J calibration coefficients above 0.999 for all USP 232 elements at 1, 5, 10 and 20 g/day doses
Calibrate easily for all USP <232> elements

Step 2

Automated sample dilution

Inline dilution to the right total dissolved solids keeps the plasma stable and surpasses USP validation criteria.

Drift over 7.5 hours with 10x inline autodilution: 93% to 102%, RSD within 2%, against the USP 20% limit
Drift: inline dilution keeps results stable for uninterrupted analysis
Accuracy: 1J spike recovery of 97% to 107% in naproxen and OTC flu remedies, against the USP 70% to 150% requirement
Accuracy: surpasses USP validation criteria
Ruggedness: six samples spiked at 0.8J over three days, average RSD 2.1% against the USP 25% limit
Ruggedness: surpasses USP validation criteria

Step 3

Auto “J” spiking

prepFAST spikes QC and validation samples at user-defined J values automatically, so the analyst prepares no spikes by hand.

  • Spike recovery of 92–108% for all elements by ICP-OES.
  • Well inside the USP <233> requirement of 70–150%.
Spike recovery for 14 elements between 92% and 108%, inside the USP 70% to 150% requirement
Spike recovery: automated QC and validation spiking removes manual sample preparation

Contact us

Questions about USP <232> and <233>, or about automating them with prepFAST? Send us a message and an applications specialist will get back to you.