What does USP 467 mean?
residual solvents
(Current chapter title is (467) Organic Volatile Impurities) For pharmacopeial purposes, residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products.
What is a Class 3 solvent?
Class 3 solvents: Solvents with low toxic potential. Solvents with low toxic potential to man; no health-based exposure limit is needed. Class 3 solvents have PDEs of 50 mg or more per day.
What are the Class 1 solvents?
Class 1 includes the solvents considered to be the most toxic, such that their use should be avoided in the production of pharmaceutical products. These chemicals are: benzene, carbon tetrachloride, 1,2-dichloroethane, 1,1-dichloroethene and 1,1,1-trichloroethane (the latter owing to its environmental impact).
How many classes of residual solvent are there?
Residual Class 2 solvents are below the Option 1 limit and residual Class 3 solvents are below 0.5% each. Only Class 3 solvents are LTBP. Loss on drying (LOD) is not greater than 0.5%. If only Class 3 solvents are LTBP and LOD is more than 0.5%, they should be identified and quantified.
What is general chapter in USP?
‘Applicable general chapters’ refers to the general chapters numbered below 1,000 in USP–NF that are made applicable to an article through reference in General Notices, a monograph, or another applicable general chapter numbered below 1,000. General chapters numbered above <1,000> in USP–NF are typically informational.
What are organic volatile impurities?
Organic volatile impurities (OVIs), commonly referred to as residual solvents, are organic volatile chemicals used or produced in the manufacturing of drug substances and excipients, or in the preparation of drug products.
What is residual solvent in GC?
Residual solvents in pharmaceuticals are defined here as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. The solvents are not completely removed by practical manufacturing techniques.
Is acetone a Class 3 solvent?
Acetone itself would be considered a Class 3 residual solvent if found in any other solvent.
How do you calculate ppm in residual solvents?
PPM ) = 3.3 × T C S / N where, TC = Concentration of solvent. S = Average signal of solvent in the test solution.
Which USP chapters are mandatory?
The text says that a General Chapter with a number below <1000> is mandatory, whereas General Chapters with numbers above <1000> are considered interpretations and thus do not represent official standards and binding requirements.