Compounding pharmacies

Identity, purity and content of the API on receipt; potency, sterility and endotoxin on the finished preparation.

API on receipt

  • Identity: retention time and UV spectrum against a reference standard, intact mass on request.
  • Purity and related substances by HPLC-UV.
  • Content in mg per vial or percent w/w.
  • Counter-ion and water content for net peptide content.

Finished sterile preparations

  • Potency against the labeled strength.
  • Sterility, USP 71, 14-day incubation.
  • Bacterial endotoxin, USP 85, EU per vial or per mL.
  • Particulate matter, USP 788, on request.

Non-sterile preparations

  • Potency.
  • Bioburden, USP 61.

Beyond-use dating

  • Stability pulls at the time points your protocol sets.

Tests and prices

$250

Purity, content, identity. 1 vial.

$550

Silver plus endotoxin and sterility. 3 vials.

$700

Gold plus heavy metals and fentanyl screen. 4 vials.

Quoted

Intact mass, sequence, mapping, impurity ID, stability, validation.

Sample and shipping

  • API: 1 vial or 50 mg.
  • Sterile preparations: separate containers for chemistry and microbiology.
  • Method suitability for USP 71 on the first submission of a new formulation.
  • Ship overnight with a cold pack for reconstituted or liquid preparations. Include the formula record for any chemistry test.

Reports

  • COA per sample: test, method, specification, result, date, reviewer.
  • Accreditation status stated per test.
  • Raw data and chromatograms on request. Verification page for every COA on verifiedbyvanguard.com.

Order

Order online or email the formulation and the tests required for a quote. Account terms available for recurring submissions.