In general, A&C will produce products meeting the appropriate compendia and wherever possible a Multi-Compendial material will be made available. This could include USP-NF, EP, JP, or JPE. The expectations and requirements of these compendia require that the materials are manufactured under Good Manufacturing Practices (GMPs). Testing non-GMP material to the compendia’s specification does not make it a Pharmacopeial Grade material. GMPs must be followed and evaluated to truly manufacture a Pharmacopeial Grade material.
So what happens if the Pharmacopeia doesn’t have a monograph? The Pharmacopoeias recognize they do not have a monograph for every Excipient used in formulations. They are working on strategies to include more materials, but these are time-consuming endeavors. FDA expects that materials chosen for use are in the Inactive Ingredient Database (IID). Therefore, there are situations requiring the use of materials that there is no Pharmacopeial Monograph available. In this case A&C will work to establish an A&C Pharma Grade material.
A&C Pharma Grade is available to assist customers in compliance with regulatory compliance. The time-frame to develop these products is 6-18 months depending on the complexity and availability of validated methodology. A&C Pharma Grade materials will provide you the control needed because all of A&C’s Pharma Grade materials are manufactured under GMPs in Montreal, Quebec. Examples of these type of products include, Levulinic Acid, Toluene, Cyclohexane, 5 N HCL.
Please contact A&C if you have a product that will require A&C’s assistance.