USP-Säulen Liste
Die United States Pharmacopeia (USP) und das National Formulary (NF) haben eine Sammlung empfohlener HPLC-Methoden und -Säulen. Hier finden Sie die Übersicht passender Shodex-Säulen.
L1
Octadecyl silane chemically bonded to porous or nonporous silica or ceramic microparticles, 1.5 to 10 μm in diameter, or a monolithic rod.
L17
Strong cation-exchange resin consisting of sulfonated cross-linked styrene-divinylbenzene copolymer in the hydrogen form, 6 to 12 μm in diameter.
L19
Strong cation-exchange resin consisting of sulfonated cross-linked styrene-divinylbenzene copolymer in the calcium form, 5-15 μm in diameter.
L20
Dihydroxypropane groups chemically bonded to porous silica or hybrid particles, 1.5-10 μm in diameter, or a monolithic silica rod.
L21
A rigid, spherical styrenedivinylbenzene copolymer, 3 to 30 μm in diameter.
L22
A cation-exchange resin made of porous polystyrene gel with sulfonic acid groups, 5-15 μm in diameter.
L23
An anion-exchange resin made of porous polymethacrylate or polyacrylate gel with quartenary ammonium groups, 7-12 μm in size.
L25
Packing having the capacity to separate compounds with a molecular weight range from 100-5000 (as determined by polyethylene oxide), applied to neutral, anionic, and cationic water-soluble polymers. A polymethacrylate resin base, cross-linked with polyhydroxylated ether (surface contained some residual carboxyl functional groups) was found suitable.
L33
Packing having the capacity to separate dextrans by molecular size over a range of 4,000 to 500,000 Da. It is spherical, silica-based, and processed to provide pH stability.
L34
Strong cation-exchange resin consisting of sulfonated cross-linked styrene-divinylbenzene copolymer in the lead form, 7 to 9 μm in diameter.
L37
Packing having the capacity to separate proteins by molecular size over a range of 2,000 to 40,000 Da. It is a polymethacrylate gel.
L38
A methacrylate-based size-exclusion packing for water-soluble samples.
L39
A hydrophilic polyhydroxymethacrylate gel of totally porous spherical resin.
L45
Beta cyclodextrin, R,S-hydroxypropyl ether derivative, bonded to porous silica particles, 3-10 μm in diameter.
L58
Strong cation-exchange resin consisting of sulfonated cross-linked styrene-divinylbenzene copolymer in the sodium form, about 6 to 30 μm in diameter.
L59
Packing for the size-exclusion separations of proteins (separation by molecular weight) over the range of 5 to 7000 kDa. The packing is a spherical 1.5- to 10-μm, silica or hybrid packing with a hydrophilic coating.
L67
Porous vinyl alcohol copolymer with a C18 alkyl group attached to the hydroxyl group of the polymer, 2 to 10 μm in diameter.
L76
Silica based, weak cation-exchange material, 5 μm in diameter. Substrate is surface polymerized polybutadiene-maleic acid to provide carboxylic acid functionalities. Capacity not less than 29 μEq/column.
L82
Polyamine chemically bonded to cross-linked polyvinyl alcohol polymer, 5 μm in diameter.
L89
Packing having the capacity to separate compounds with a molecular weight range from 100 to 3000 (as determined by polyethylene oxide), applied to neutral and anionic water-soluble polymers. A polymethacrylate resin base, cross-linked with polyhydroxylate ether (surface contains some residual cationic functional groups).
L125
Polyvinyl alcohol polymer gel weak cation-exchange packing material, 3-7 μm porous particles. The surface is polymerized with polybutadiene-maleic acid to provide carboxylic acid functionalities. The capacity is NLT 1 mEq/column.
Zulässige HPLC-Anpassungen für USP-Methoden
Basierend auf: United States Pharmacopeia 42 - National Formulary 37 (USP 42-NF 37), 1. Juni 2019
Die USP wird mindestens zweimal jährlich aktualisiert.
Allgemeines Kapitel zur Chromatographie <621> enthält eine Liste der zulässigen Anpassungen an chromatographischen Systemen, die vorgenommen werden können, um die Anforderungen an die Systemeignung zu erfüllen. Die Anwendenden sollten jedoch die Eignung der Methode unter den neuen Bedingungen durch Bewertung der relevanten analytischen Leistungsmerkmale überprüfen, die möglicherweise von der Änderung betroffen sind (eine vollständige Neuvalidierung ist nicht erforderlich).
Column Length (L)
Isocratic:
Column length (L) to particle size (dp) ratio (L/dp) can be adjusted between -25% and +50% (or theoretical plate number N -25% and +50%)
Gradient:
Changes not allowed
Particle Size (dp)
Isocratic:
Column length (L) to particle size (dp) ratio (L/dp) can be adjusted between -25% and +50% (or theoretical plate number N -25% and +50%)
Gradient:
Changes not allowed
Column Internal Diameter (dc)
Isocratic:
Can be adjusted so long as linear velocity is maintained
Gradient:
Changes not allowed
Flow Rate (F)
Isocratic:
±50% or
F2 = F1 × [(dc22 × dp1)/(dc12 × dp2)]
Gradient:
Changes not allowed
Column Temperature
Isocratic:
±10°C
Gradient:
±10°C
Mobile Phase Composition
Isocratic:
For minor component ±30% relative, or ±10% absolute whichever is smaller
Gradient:
Not recommended
Mobile Phase pH
Isocratic:
±0.2 pH units
Gradient:
±0.2 pH units
Buffer Salt Concentration
Isocratic:
±10%
(if the permitted pH range is met)
Gradient:
±10%
(if the permitted pH range is met)
Injection Volume
Isocratic:
Can be adjusted as far as it is consistent with accepted
precision, linearity, and detection limits
Gradient:
Can be adjusted as far as it is consistent with accepted precision, linearity, and detection limits
Detector UV Wavelength
Isocratic:
Changes not allowed
Gradient:
Changes not allowed
Guard Column
Isocratic:
Same stationary phase as column;
guard ID ≤ column ID;
guard length ≤ 15% column length
Gradient:
Same stationary phase as column;
guard ID ≤ column ID;
guard length ≤15 % column length
Stationary Phase
Isocratic:
Changes not allowed
Gradient:
Changes not allowed