Secondary Reference Standard Qualification. Resolution used to determine assay performance or impurity method qualification. A reference standard i e primary standard may be obtained from the usp nf or other official sources e g cber 21 cfr 610 0.
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A secondary standard is established and employed to reduce the use of the primary standard which requires more extensive characterization and evaluation and may be available only in a limited quantity. 5 0 definition of terms sop for working standard qualification. Resolution used to determine assay performance or impurity method qualification.
A working standard i e in house or secondary standard is a standard that is qualified against and used instead of the reference standard 3 united states pharmacopeia general chapter 1010.
A reference standard i e primary standard may be obtained from the usp nf or other official sources e g cber 21 cfr 610 0. Such working standards are assigned a limited validity depending on stability of the material and before expiry fresh working standards should be prepared for future use. This information can help analysts determine essential parameters for qualification. Reference standard is pharmacopoeial standard material bpcrs usprs or from any other pharmacopeia that is intended for use in specified chemical and physical tests in which its properties are compared with properties of samples under examination and is.
