How do you qualify a reference standard?
How do you qualify a reference standard?
The reference standard should be of the highest purity possible; the drug substance may require further purification to become a reference standard (additional purification steps used for a drug substance should be fully described and included in any regulatory filing).
What is inhouse reference standard?
In-House Interim Reference Standard: Appropriately characterized material prepared from representative clinical or production lot(s) used for quality control purposes during the development stage of a product.
Which standard is known as reference standard?
A reference standard is a prerequisite to measuring potency. To measure potency, a sample of unknown potency must be compared to a standard of known potency, so that the potency ratio can be calculated.
What are reference standards in pharma?
A pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.
What are reference standards USP?
A USP Reference Standard (also known as a physical standard) is a known quantity of a drug substance or ingredient, developed in alignment with the specifications outlined in the USP–NF.
What is reference standard and working standard?
“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). A working standard (i.e., in-house or secondary standard) is a standard that is qualified against and used instead of the reference standard.”
How do you store reference standards?
A good practice is to always store your reference standards, including those at room temperature, away from light. Some additional precautions to avoid light exposure are to work under yellow light and to use red-tinted glassware when preparing dilutions.
