Many pharmaceutical companies use chromatography to analyze their products. Chromatography is easy to perform, and provides accurate, repeatable data. However, to determine repeatability, U.S. Pharmacopoeia developed a validation process. USP validation for HPLC methods is detailed in the “Analytical Performance Parameters” (USP {225}). The typical analytical characteristics used in method validation include: accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, and ruggedness. SIELC has developed the Legacy column, which can be used in many USP Validated methods.
SIELC Column | USP Specification |
Legacy L1
|
Octadecyl silane chemically bonded to porous silica or ceramic particles (1.5 to 10µm)
|
Legacy L3 | Porous silica microparticals 1.5 to 10µm in diameter |
Legacy L7 | Octyl silane (C8) chemically bonded to porous silica particle- 1.5 to 10µm in diameter |
Legacy L8 | An essentially mono-molecular layer of aminopropylsilane chemically bonded to totally porous silica gel support, 3-10µm diameter
|
Legacy L10 | Nitrile groups chemically bonded to porous silica particles 3 to 10µm in diameter
|
Legacy L11 | Phenyl groups chemically bonded to porous silica particles 1.5 to 10µm in diameter
|
Legacy L14 | Silica gel, 5 to 10µm in diameter, having a chemically bonded, strongly basic quaternary ammonium anion exchanger (SAX) coating.
|
Legacy L16 | Dimethylsilane (C2) chemically bonded to totally porous silica particles- 5 to 10µm. |
Legacy L26 | Butyl silane (C4) chemically bonded to porous silica particle- 3 to 10µm. |
Legacy L28 | A multi-functional support which consists of a high purity, 100A, spherical silica substrate that has been bonded with anionic (amine) functionality in addition to conventional reversed-phase C8 functionality. |
Legacy L44 | A multi-functional support, which consists of high purity, 60A, spherical silica substrate that has been bonded with a cationic exchanger, sulfonic acid functionality in addition to a convention reversed-phase C8 functionality |