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USP Monographs

The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP’s standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years. USP Monographs are standards that specify the quality attributes of thousands of ingredients, raw materials excipients and finished products sold in the United States. These standards are recognized as official by the United States Food and Drug Administration. An example of a USP Monograph is Aspirin.

The nine quality attributes that must be certified by qualified laboratories such as Gibraltar Laboratories are listed below

USP Aspirin

C9H8O4 180.16

  1. Identification—
  2. Loss on drying 731
  3. Readily carbonizable substances 271
  4. Residue on ignition 281:
  5. Chloride 221—
  6. Sulfate
  7. Heavy metals
  8. Limit of free salicylic acid
  9. Assay
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About Daniel

Dr. Daniel Prince is president of Gibraltar Laboratories Inc. He has led the Company’s expansion and growth since 1987. View all posts by Daniel

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