USP column list
 

The United States Pharmacopeia (USP) has a collection of recommended HPLC methods and columns. Here you find the overview of suitable Shodex columns (according to version USP 44-NF39).

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.

L71

A rigid, spherical polymetacrylate, 4 to 6 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).

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

Allowable HPLC Adjustments for USP methods

 

Based on: United States Pharmacopeia 42 - National Formulary 37 (USP 42-NF 37), June 1, 2019

The USP is updated at least twice a year.

 

Chromatography General Chapter <621> contains a list of allowable adjustments to chromatographic systems, that may be made to meet system suitability requirements. However, the user should verify the suitability of the method under the new conditions by assessing the relevant analytical performance characteristics potentially affected by the change (full re-validation not required).

Please also refer to: www.usp.org/help/scientific-support