• RT Pharma’s PRSs offer the users substantial economic savings with their large quantities (2-20x that of Pharmacopeial Reference Standards) and low pricing. The use of PRSs increases laboratory efficiency by allowing laboratories to focus on value producing activities, rather than on routine qualification processes.


  • RT Pharma PRSs are typically qualified to the United States Pharmacopeia, European Pharmacopeia and British Pharmacopeia and are re-qualified as new lots are released by a Pharmacopeial entity.



The use of Secondary Reference Standards are Recognized by Regulatory Authorities.



US FDA

Guidance for Industry; Analytical Procedures and Methods Validation; Chemistry, Manufacturing, and Controls Documentation; Draft Guidance:
“A reference standard (i.e., primary standard) may be obtained from the USP/NF or other official sources (e.g., CBER, 21 CFR 610.20). A working standard (i.e., in-house or secondary standard) is a standard that is qualified against and used instead of the reference standard.”

USP

USP30-NF25: General Chapter <1010> Analytical Data-Interpretation and Treatment:
“Use of Reference Standards: Where the use of USP Reference Standards is specified, the USP Reference Standard, or a secondary standard traceable to the USP Reference Standard, is used.”

EP

European Pharmacopoiea 5th Edition 2007: Chapter 5.12. REFERENCE STANDARDS:
“Secondary standard. A standard established by comparison with a primary standard. The secondary standard is established by comparison with the primary standard to which it is traceable. An official primary standard is used wherever possible for establishment of secondary standards.”