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What are USP Standards?

The U.S. Pharmacopeia (USP) is a nonprofit organization aimed at helping to improve human health worldwide through the creation of standards that ensure the “quality, safety, and benefit of medicines and foods.” Additionally, the USP publishes drug product and ingredient...

by | Mar 3, 2023

USP standards

The (USP) is a nonprofit organization aimed at helping to improve human health worldwide through the creation of standards that ensure the “quality, safety, and benefit of medicines and foods.”

The U.S. Pharmacopeia (USP) is a nonprofit organization aimed at helping to improve human health worldwide through the creation of standards that ensure the “quality, safety, and benefit of medicines and foods.” Additionally, the USP publishes drug product and ingredient information annually.

Drug and drug products subject to USP standards include products intended for both humans and animals. Additionally, USP sets standards relating to dietary supplements and food ingredients. The standards created by USP are used by regulatory agencies and product manufacturers to ensure products are of the highest quality, strength and consistency.

USP has developed more than 3,500 reference standards specific to drug substances, antimicrobial drugs, food ingredients, supplements, and more to reinforce quality medicine and improve public health.

USP is always drafting new standards. Current standards under review include those relating to carotene pigments important for photosynthesis, alosetron hydrochloride tablets, bendamustine compounds, and the glaucoma medication bimatoprost.

Contract Laboratory has helped many companies and organizations find laboratories to test their product according to USP standards, like the following:

  • Pharmaceutical analytical chemistry laboratory needed for Certificate of Analysis COA testing to USP Standards for Chlorhexidine Digluconate gel to confirm results that it is within 90%-110% concentration for the medicine
  • A large chemical company needed an analytical chemistry laboratory for the identification of sulfur species in liquid samples. Analysis of our sample by XRF shows the presence of sulfur but our GC instruments don’t detect any sulfur. We use a GC equipped with a PFPD and a non-polar capillary column
  • Pharmaceutical analytical chemistry laboratory needed for USP Testing to USP 39 Volume 3 monograph for Mangafodipir TriSodium Test for Excess Manganese and Fodipir using Photometric titration at wavelength 620 nm
  • A pharmaceutical analytical chemistry laboratory is needed for USP testing of thyroid powder according to the USP Monograph
  • A cosmetics analytical chemistry laboratory is needed for formulation investigation into a precipitate forming in a water-based liquid finished product. The precipitate is suspected to be inorganic as it will not dissolve in Methanol, Propanol, Hexane and Chloroform
  • Pharmaceutical analytical chemistry laboratory needed for United States Pharmacopeia (USP) 27 testing for extractables and light transmission.
  • LONG-TERM TESTING A Bioanalytical laboratory is needed for conducting the bioassay required for Vasopressin as per USP 29 Identification Test B
  • FDA registered and GMP analytical laboratory needed for USP assay analysis and method verification of Azithromycin for Oral Suspension according to the most recent USP method by amperometric electrochemical detector.
  • and more!

Save yourself time and money by letting us here at Contract Laboratory help! Submit your test request by calling 1-855-377-6821 or online!

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