PurePoint Analytical

Testing Methods

Rigorous methods, plainly explained

Every panel below lists the instrumentation we use and how much sample material it requires, so there are no surprises when you ship.

Purity Analysis (HPLC/UV)

HPLC with UV-Vis Detection

High-performance liquid chromatography with UV detection to determine purity relative to any impurities or degradation products.

Runs from your submitted vial
2–3 days turnaround

Net Content / Quantity Check

Gravimetric + HPLC Quantitation

Confirms the true quantity present in a sample against the labeled amount, accounting for residual solvents or moisture.

Runs from your submitted vial
2–3 days turnaround

Identity Confirmation (LC-MS)

LC-MS (ESI+)

Liquid chromatography coupled with mass spectrometry to confirm molecular identity against expected molecular weight.

Runs from your submitted vial
2–3 days turnaround

Endotoxin Analysis

Kinetic Chromogenic LAL, USP <85>

Quantitative bacterial endotoxin testing reported in EU/mL against defined acceptance limits.

Runs from your submitted vial
2–3 days turnaround

Heavy Metal Analysis

ICP-OES, USP <232>/<233>

Quantitative elemental analysis for lead, mercury, arsenic, cadmium, and other regulated elemental impurities.

Runs from your submitted vial
3–4 days turnaround

Rapid Sterility Screen

Membrane Filtration + Chromogenic Detection

Fast preliminary indicator of microbial burden (aerobic, anaerobic, yeast, and mold). Not a substitute for full compendial sterility testing.

Runs from your submitted vial
2–3 days turnaround

14-Day Sterility Screening

Automated microbial detection, aerobic + anaerobic

Preliminary rapid results after 2 days of monitoring, with the COA updated upon completion of the full 14-day incubation.

Runs from your submitted vial
3–15 days turnaround

Fentanyl Presence Analysis

Targeted LC-MS/MS Screening

Targeted screening for fentanyl and common fentanyl analogs. Reported as detected or not detected against an established cutoff.

Runs from your submitted vial
2–3 days turnaround

pH Analysis

Potentiometric pH Measurement

Measures the pH of a reconstituted solution.

Runs from your submitted vial
2 days turnaround

Benzyl Alcohol Content

HPLC with UV-Vis Detection

Quantifies the benzyl alcohol preservative concentration in bacteriostatic water by HPLC, reported against the labeled percentage.

Runs from your submitted vial
2–3 days turnaround

Reconstitution & Solubility Check

Visual Clarity + HPLC Recovery

Confirms your peptide goes fully into solution. We reconstitute with your specified diluent at the target concentration and report time to full dissolution, visual clarity and particulate inspection, percent recovery of dissolved peptide by HPLC, and the pH of the reconstituted solution.

Runs from your submitted vial
2–3 days turnaround

Microbial Enumeration

Plate Count, USP <61>/<62>

Quantitative microbial enumeration: total aerobic microbial count (TAMC) and total yeast and mold count (TYMC), reported as CFU against defined acceptance limits per USP <61> and <62>. A quantitative count, distinct from the pass/fail Rapid Sterility Screen.

Dedicated vial, sampled aseptically
5–7 days turnaround

Every COA includes both purity and identity

We never issue a purity number without identity confirmation — a purity result alone is an incomplete answer.

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