Peptide Testing for Compounding Pharmacies

Independent identity, purity, endotoxin, and contaminant testing for 503A and 503B pharmacies. Audit-ready COAs in 5–7 business days.

Quick Answer

Why do compounding pharmacies need third-party peptide testing?

Compounding pharmacies use third-party peptide testing to verify supplier Certificates of Analysis, document USP-style identity and purity for each lot, screen for endotoxin and heavy metals on injectable preparations, and maintain a defensible quality record for state board and FDA inspections. ACS Peptide Testing Labs provides HPLC purity, mass spectrometry identity, LAL endotoxin, and ICP-MS contaminant testing from a single US-based facility, with results returned in 5–7 business days.

•Independent verification of supplier COAs
•Lot-by-lot identity and purity documentation
•LAL endotoxin testing for injectable lots
•ICP-MS heavy metal screening (Pb, Hg, As, Cd)
•Audit-ready electronic Certificate of Analysis

What We Test for Pharmacies

Identity Confirmation

Mass spectrometry confirms each peptide matches its labeled sequence and molecular weight before compounding.

Purity by HPLC

Reversed-phase HPLC quantifies main-peak purity and characterizes deletion sequences and synthesis impurities.

LAL Endotoxin

Quantitative endotoxin testing in EU/mg for injectable peptide preparations.

Heavy Metals (ICP-MS)

Trace screening for lead, mercury, arsenic, and cadmium at parts-per-billion sensitivity.

Residual Solvents

GC-MS detection of TFA, DMF, DCM, and acetonitrile remaining from synthesis.

Lot Release Testing

Recurring programs for ongoing lot-by-lot release with predictable turnaround.

Why Pharmacies Choose ACS

US-based, single facility

All testing runs at our Florida lab. No samples shipped overseas, no chain-of-custody gaps.

Inspection-ready documentation

COAs include methods, instrument data, acceptance criteria, and analyst signature for state board and FDA review.

Bulk and recurring pricing

Volume pricing for ongoing release programs, with predictable monthly invoicing.

Direct chemist contact

Talk to the analyst running your sample. No call-center, no offshore handoff.

Pharmacy FAQ

At minimum: identity confirmation by mass spectrometry, purity by HPLC, endotoxin by LAL, and heavy metal screening by ICP-MS. Many pharmacies also add residual solvent testing (GC-MS) and water content for sterile injectable lots.

Yes. Our COAs include peptide name and sequence, lot number, test methods, acceptance criteria, individual results, instrument data, and analyst signature, formatted for board of pharmacy and FDA inspection records.

Yes. We can issue Certificates of Analysis addressed to your pharmacy or to the contract sponsor of record. Discuss white-label or co-branded reporting with our team when you request a quote.

Standard turnaround is 5–7 business days from sample receipt.

Yes. We support both 503A traditional compounding pharmacies and 503B outsourcing facilities, with bulk pricing for ongoing programs and recurring lot release testing.