Many pharmaceutical companies use chromatography to analyze their products. Chromatography is easy to perform, and provides accurate, repeatable data. To provide repeatability, U.S. Pharmacopeia 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.
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Sielc Column
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USP Specification
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Legacy L1
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Octadecyl silane chemically bonded to porous silica or ceramic particles (1.5 to 10µm)
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Legacy L3
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Porous silica microparticals 1.5 to 10µm in diameter
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Legacy L7
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Octyl silane (C8) chemically bonded to porous silica particle- 1.5 to 10µm in diameter
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Legacy L8
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An essentially monomolecular layer of aminopropylsilane chemically bonded to totally porous silica gel support, 3-10µm diameter
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Legacy L10
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Nitrile groups chemically bonded to porous silica particles 3 to 10µm in diameter
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Legacy L11
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Phenyl groups chemically bonded to porous silica particles 1.5 to 10µm in diameter
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Legacy L14
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Silica gel, 5 to 10µm in diameter, having a chemically bonded, strongly basic quaternary ammonium anion exchanger (SAX) coating.
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Legacy L16
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Dimethylsilane (C2) chemically bonded to totally porous silica particles- 5 to 10µm.
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Legacy L26
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Butyl silane (C4) chemically bonded to porous silica particle- 3 to 10µm.
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Legacy L28
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A multifunctional 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.
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Legacy L44
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A multifunctional 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
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