Item no.
USP-CM-788-01
Unit
Each
Shipment details
No Dangerous Good
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Description
Particle determination for sterile injectable products has been required for more than 30 years, however, recent improvements in standard methods for sensitive protein products have brought changes and additional background information to the Compendial guidance. This course will discuss the current, USP <788> Particulate Matter in Infections and <1788> Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions, requirements for sub-visible particle determination. In addition, a discussion on the new USP General Chapter <787>Subvisible Particulate Matter in Therapeutic Protein Injections for particle determination in protein formulations and the informational USP Chapter <1787> Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections which provides background and rationale for sub-10µm characterization. A portion of the course will focus on visible particle determination and the two new Compendial chapters on the topic, USP <790> Visible Particulates in Injections and <1790> Visual Inspection of Injections
Miscellaneous
Certificate of Analysis (specimen)
Reference Material CoA specimen: for the current lot, please contact your customer service representative at info@labmix24.com
Product data sheet
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US Pharmacopeia Standards set a global benchmark, enabling efficient, reliable, and cost-effective development and quality control of pharmaceuticals.
Official USP Reference Standards are highly characterized physical specimens intended for quality control use when conducting assays and tests for medicines as described in the USP-NF. When you conduct tests and assays required by the USP-NF using the USP reference standards specified, the results can be considered conclusive.
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- USP Reference Standards
- USP Pharmaceutical Analytical Impurities
- USP Training and educational programs