America Testing
Our Services

Tests we perform

From potency and purity to microbiology and contaminant screening, we offer a full range of analytical services.

Potency & Purity

Quantitative Analysis (HPLC)

$120 per compound

Measures the exact concentration of the active compound in a sample and reports its purity as a percentage of the label claim.

  • Reports measured amount versus label claim (mg, mg/mL, or % w/w).
  • Identifies under-dosing and over-dosing.
  • Ideal for peptides, small molecules, and finished products.

Method

High-Performance Liquid Chromatography (HPLC-UV/DAD)

Turnaround

2-4 business days

Purity & Impurity Profile

$180 per sample

Quantifies the main compound and detects related substances or impurities present in the sample.

  • Reports total purity percentage.
  • Lists detected impurities above the reporting threshold.
  • Recommended for raw material qualification.

Method

HPLC with area-percent impurity quantification

Turnaround

3-5 business days

Multi-Compound Blend Analysis

$145 per compound

Quantifies each active ingredient in blended or multi-component products.

  • Reports individual concentrations for each active.
  • Ideal for blends and combination products.
  • Volume-based pricing for large panels.

Method

HPLC with multi-analyte calibration

Turnaround

4-6 business days

Identity

Identity Confirmation (LC-MS)

$170 per compound

Confirms the molecular identity of a compound by matching its mass and fragmentation pattern.

  • Verifies that the sample contains the labeled substance.
  • Detects substitutions and mislabeled products.
  • Provides molecular weight confirmation.

Method

Liquid Chromatography-Mass Spectrometry (LC-MS)

Turnaround

3-5 business days

Microbiology

Sterility Testing

$290 per sample

Determines whether a sample is free from viable microorganisms.

  • Required for injectable and sterile products.
  • Detects bacterial and fungal contamination.
  • Pass/Fail result with incubation records.

Method

Membrane filtration / direct inoculation (USP <71>)

Turnaround

14 business days

Bacterial Endotoxin (LAL)

$180 per sample

Detects and quantifies bacterial endotoxins that can cause adverse reactions.

  • Reports endotoxin units per mL or per mg (EU/mL, EU/mg).
  • Critical for parenteral and injectable products.
  • Compared against acceptance limits.

Method

Limulus Amebocyte Lysate (LAL) kinetic assay

Turnaround

5-7 business days

Contaminants

Heavy Metals Screening (ICP-MS)

$105 per sample

Screens for toxic heavy metals such as lead, arsenic, cadmium, and mercury.

  • Quantifies metals down to parts-per-billion (ppb).
  • Compared against USP <232>/<233> limits.
  • Recommended for consumables and raw materials.

Method

Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

Turnaround

5-7 business days

Residual Solvents (GC)

$170 per sample

Detects leftover manufacturing solvents that may remain in the final product.

  • Identifies Class 1, 2, and 3 solvents.
  • Reports concentration in ppm.
  • Compared against ICH Q3C limits.

Method

Gas Chromatography (GC-FID/MS headspace)

Turnaround

5-7 business days

Need a custom or high-volume panel?

We offer volume pricing and custom method development. Contact us and we will build a testing plan for your needs.

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