Item no.
USP-EXC-WS-08
Unit
Each
Shipment details
No Dangerous Good
Back to your search result
Description
Excipients in generic drug products are evaluated from clinical and nonclinical perspectives to ensure that they do not alter the safety profile of the formulation as compared to the Reference Listed Drug.<br> FDA Pharmacology/Toxicology Review of the proposed level of an excipient includes an evaluation of toxicology data to support the dose, route of administration, duration of exposure and patient population (Webcast 34 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