April 9, 2018
The USP has been working on changing the guidelines for testing heavy metals for several years. More specifically, the USP chapter to change will be <231> . The new USP chapters that will be effective are <232> and <233>. The...
See BlogFebruary 28, 2018
Established in 1970, the Environmental Protection Agency (EPA) is purposed to protect human health and the environment. One of the responsibilities of the EPA is to provide guidance on how to evaluate products in the marketplace with claims. One of...
See BlogFebruary 5, 2018
With an incubation period of at least 14 days, it’s no secret that the current compendial sterility tests are too long for a variety of industries and product types. The USP expert panel identifies four main stakeholders when discussing the need for...
See BlogSeptember 7, 2017
On September 6, 2017 the Food and Drug administration (FDA) final rule banning a list of 29 consumer antiseptic wash ingredients officially became in effect. This rule strictly bans the usage of certain ingredients commonly used in the manufacturing of...
See BlogJune 7, 2017
In June of 1936 the United States Pharmacopeia (USP) implemented the sterility test to better ensure the sterility of parenteral drug products. The test utilized one type of media and applied only to sterile liquids. Since then slight modifications have...
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