Loading…
Product type
Residual solvent standards are reference materials used in the pharmaceutical industry to ensure compliance with regulatory guidelines regarding solvent residues in drug products. These standards are typically composed of known quantities of specific solvents, which can include organic solvents like ethanol, methanol, and acetonitrile. They are essential for validating analytical methods and ensuring that the levels of solvents in pharmaceuticals are within acceptable limits as defined by regulatory bodies such as the FDA and ICH.
| Purity | Typically greater than 95% |
| Form | Liquid |
| Storage conditions | Cool, dry place, away from light |
| Packaging | Vials or bottles, typically 10 mL to 100 mL |
| Shelf life | Usually 1 to 3 years |
When selecting residual solvent standards, buyers should consider the specific solvents they need to test for and ensure the standards are appropriate for their analytical methods. It's important to specify the required purity levels, packaging sizes, and any necessary certifications or compliance with regulatory standards. Buyers should also inquire about shelf life and storage conditions to ensure the standards remain effective throughout their use.
Get quotes for Residual Solvent Standards
Tell us your requirement — quantity, specs and timeline — and our team sources verified manufacturers and brings you the best quote.
They are used to validate analytical methods and ensure compliance with solvent residue limits in pharmaceuticals.
They should be stored in a cool, dry place, away from light.
The shelf life is usually between 1 to 3 years.
Typically, they have a purity greater than 95%.
They are usually available in liquid form.
They are commonly packaged in vials or bottles, with sizes ranging from 10 mL to 100 mL.