Item no.
USP-EXC-WS-07
Unit
Each
Shipment details
No Dangerous Good
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Description
Formal risk assessment is a natural progression of the FDA 21st Century Quality Initiative.<br> Formal risk management approaches are being used in Abbreviated New Drug Application (ANDA) review to ensure that all high-risk areas receive appropriate scrutiny to ensure the availability of high-quality generics.<br> Mitigation of high-risk areas may necessitate stringent controls of critical material attributes of excipients.<br> Formal risk management will also streamline the review of lower-risk areas to ensure review timelines under the reauthorized FDA Generic Drug User Fee Amendments. (Webcast 33 minutes)
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
View all available product details e.g. description, analytes/parameters, CAS Number, concentrations/values, sales unit/product format, method, source, transport information
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.
As a USP-Authorized Distributor, we offer the following products and services:
- USP Reference Standards
- USP Pharmaceutical Analytical Impurities
- USP Training and educational programs