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HPLC Column Selection according to Ph. EUR.
The European Pharmacopoeia (Ph. Eur.), also known as the European Pharmacopoeia, sets standards and requirements for medicines and pharmaceutical products in Europe and is the reference work for quality control. It serves to harmonize national regulations for the manufacture and distribution of medicines and other pharmaceutical products.
Ph. Eur. and HPLC Columns
The requirements for column material, particle size, surface chemistry, and other important parameters affecting separation performance are specified. The specific tests and procedures for the characterization and testing of HPLC columns are described in the respective chapters of the pharmacopoeia.
HPLC columns that comply with the standards of the European Pharmacopoeia are used in various pharmaceutical applications, including drug analysis, purity determination, identification of impurities, and quantitative analysis in drug development and manufacturing.
The following list contains HPLC columns suitable for pharmacopoeial requirements. Please contact us with any questions - we are happy to help our customers find the suitable HPLC column.
Overview of HPLC Columns according to Pharmacopoeia Ph. EUR.
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Pharmaceutical Substance with Monograph Number |
Reagent Code Number |
Recommended Column Type |
Suitable Columns |
Column Dimensions | Description |
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1171700 |
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Silica gel AD for separation of chiral components, RP 5µm. Coated with substituted amylose. |
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1161300 |
ChiraDex, 5µm, Hibar RT 250 x 4,6mm |
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Silica gel BC for separation of chiral components, RP 5µm. Coated with ß-Cyclodextrin. |
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1192400 |
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Silica gel CR+ for separation of chiral components. RP. Coated with crown ether. |
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1176900 |
Silica gel. Alkylated, silanized RP with endcapping. Chemically modified by introduction of alkyl groups to be suitable for strongly aqueous mobile phases. |
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Silica gel AD for separation of chiral components, RP 5µm. Coated with substituted amylose. |
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1109800 |
Very fine silica gel (10µm) whose surface is chemically modified by introduction of amylose groups. RP. |
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1188400 |
HALO AQ-C18, 90 Å |
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Very fine silica gel with bonded octadecylsilyl groups, suitable for use with strongly aqueous mobile phases, including 100% aqueous phases. |
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1194200 |
GL-Sciences InertSustain Cyano |
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Very fine silica gel, pretreated by growing and hydrolysing most of the surface siloxane bridges before grafting the cyanopropylsilyl groups. |
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1168100 |
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Very fine silica gel, whose surface is chemically modified by introduction of diisobutyloctadecylsilyl groups. |
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1077200 |
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Very fine, surface-modified silica gel with hydrophilic properties. |
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1174500 |
GL-Sciences InertSustain Cyano |
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Very fine silica gel, the surface of which is chemically modified by the introduction of cyanopropylsilyl groups. Cyanopropylsilylated, post-silanized RP. |
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1115400 |
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Very fine silica gel, the surface of which is chemically modified by the introduction of octadecylsilyl groups. Octadecylsilylated, post-silanized RP. |
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1154500 |
Validation Kit Chromolith |
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Monolithic rods made of highly porous (over 80%), metal-free quartz with bimodal pore structure and a surface chemically modified by the introduction of octadecylsilyl groups. |
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1177900 |
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Silica gel for chromatography, octadecylsilyl, with embedded polar groups, with end-caps; the particles are based on a mixture of silica modified on the surface by bonding octadecylsilyl groups chemically and silica modified with a reagent that yields a surface with chains containing embedded polar groups. |
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1165100 |
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Very fine silica gel, the surface of which is chemically modified by the introduction of polar groups and terminal octadecyl groups. |
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1190500 |
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Synthetic, spherical, ethane-1,2-diyl-bridged hybrid particles containing both inorganic (silica) and organic (organosiloxane) components and whose surface is chemically modified by the introduction of octadecylsilyl groups. |
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1193900 |
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Silica gel with spherical silica dioxide particles consisting of a non-porous, solid silica dioxide core surrounded by a thin, porous, octadecylsilylated silica dioxide layer. |
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1196700 |
Kromasil EternityXT-10-C18 |
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Very fine silica gel, the surface of which is chemically modified by the introduction of octadecylsilyl groups, which are resistant to bases up to a pH of 11. |
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1155200 |
ZORBAX StableBond SB-C8, 80Å |
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Highly pure, very fine silica gel, the surface of which is chemically modified by the introduction of octylsilyl groups and sterically protected by attachment of branched hydrocarbons to the silanes. |
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1200900 |
GL Sciences InertSustain C8 |
InertSustain C8 100Å |
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Very fine silica gel, the surface of which is chemically modified by the introduction of densely linked octylsilyl groups. |
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1153900 |
GL Sciences InertSustain |
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Very fine silica gel, the surface of which is chemically modified by the introduction of phenylhexylsilyl groups. |
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1170600 |
GL Sciences InertSustain |
InertSustain Phenylhexyl 100Å |
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Silica gel for chromatography, phenylhexylsilylated, reconditioned R. Very fine silica gel, the surface of which is chemically modified by the introduction of phenylhexylsilyl groups. |
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1198900 |
ACE Ultracore 2,5 |
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Silica gel with spherical silica dioxide particles consisting of a non-porous, solid silica dioxide core surrounded by a thin, porous, phenylhexylsilylated silica dioxide layer. |
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1075700 |
ZORBAX StableBond SB-C8, 80Å, 5 µm |
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Silica gel for chromatography, phenylsilylated, R1 spherical silica; pore size: 80 Å; surface area: 180 m2/g; C load: 5.5%. |
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1154900 |
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Very fine silica gel, the surface of which is chemically modified by the introduction of phenyl groups. To minimize interactions with basic compounds, it is carefully end-capped, covering most of the remaining silanol groups. |
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1197900 |
GL Sciences InertSustain Phenyl |
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Very fine silica gel, largely freed from siloxane bridges on the surface by washing and hydrolysis prior to introduction of phenylsilyl groups, and chemically modified by introduction of phenyl groups. |
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1200700 |
XTerra Phenyl 3.5µm |
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Synthetic, spherical, ethan-1,2-diyl-bridged hybrid particles containing both inorganic (silicon dioxide) and organic (organosiloxane) components, and chemically modified by introduction of phenylsilyl groups on the surface. |
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1174600 |
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Very fine silica gel, the surface of which is chemically modified by introduction of propoxyphenyl groups. |
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1170700 |
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Very fine silica gel, the surface of which is chemically modified by introduction of propylsilyl groups. |
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1077800 |
Silica gel anion exchanger, RP. Very fine silica gel whose surface is chemically modified by introduction of quaternary ammonium groups. |
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1161400 |
EC 250/4,6 NUCLEOSIL 100-5 SA |
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Silica gel for exclusion chromatography. Very fine silica gel (10µm) with a hydrophilic surface. The average pore size is about 30nm. The substance, which can be used in aqueous solutions with a pH between 2 and 8 and in organic solvents, is for the separation of proteins with a relative molecular mass of 1,000 to 300,000. |
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1077900 |
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Silica gel for exclusion chromatography. Very fine silica gel (10µm) with a hydrophilic surface. The average pore size is about 30nm. The substance, which can be used in aqueous solutions with a pH between 2 and 8 and in organic solvents, is for the separation of proteins with a relative molecular mass of 1,000 to 300,000. |
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1110300 |
Daicel Chiralcel OD |
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Silica gel-cellulose derivative for separation of chiral components. |
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1144200 |
Polymer, silicon organic, amorphous, octadecylsilylated R. Synthetic, spherical hybrid particles containing both inorganic (silicon dioxide) and organic (organosiloxane) components. The surface is modified by introduction of 3-fold bonded octadecylsilyl groups. |
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1164900 |
Xbridge C18 250 mm |
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Synthetic, spherical hybrid particles containing both inorganic (silicon dioxide) and organic (organosiloxane) components and chemically modified surface by introduction of octadecylsilyl groups. |
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1191500 |
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Vinyl polymer, aminoalkylated RP Spherical particles (5µm) of a vinyl alcohol copolymer whose surface is chemically modified by introduction of aminoalkyl groups. |
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1155400 |
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Vinyl polymer, octadecylated RP. Spherical particles (5µm) of a vinyl alcohol copolymer whose surface is chemically modified by introduction of octadecyl groups bonded to the hydroxyl groups. |
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1121600 |
Asahipak ODP-50 4E, 250 Å |
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Vinyl polymer, octadecylsilylated RP. Spherical particles of a vinyl alcohol copolymer (5µm), to which octadecylsilane is bound. |
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1131000 |
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Ion exchanger. Exchange resin with sulfonic acid groups fixed to a framework of polystyrene crosslinked with divinylbenzene. |
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1156800 |
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Strong cation exchanger resin in protonated form with sulfonic acid groups fixed to a framework of polystyrene crosslinked with divinylbenzene. |
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1016700 |
Carbomix H-NP5, 8% Crosslinkage, |
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Cation exchanger resin in protonated form. The resin is in the form of beads. The exchanger contains sulfonic acid groups fixed to a framework of polystyrene crosslinked with 8% divinylbenzene. |
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1104600 |
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Cation exchanger, calcium salt, strongly acidic RP. Exchange resin with sulfonic acid groups fixed to a polymer framework consisting of polystyrene crosslinked with 5% divinylbenzene. |
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1176100 |
SUGAR KS-801, Na+, 6 µm, 8 x 300 mm |
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Cation exchanger, sodium salt, strongly acidic RP. Exchange resin with sulfonic acid groups fixed to a polymer framework consisting of polystyrene crosslinked with divinylbenzene. |
Permissible Deviations according to Ph. Eur.
The Ph. Eur. allows deviations in the dimensions of HPLC columns in the respective methods. This provides the user of classical HPLC with generous flexibility to optimize the method for their conditions without requiring revalidation of the entire method.
If adjustments to the parameters are made within the permissible limits, demonstrating system suitability is sufficient, and revalidation of the modified method is not required. The primary aim of an adjustment is generally to optimize a method to meet system suitability requirements.
According to current regulations (Ph. Eur. General Chapter 2.2.46), the following modifications are permissible:
| Property | Gradient Elution | Isocratic Elution |
|---|---|---|
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Column Length |
± 70 % |
± 70 % |
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Particle Size |
no adjustment allowed |
Reduction by max. 50%; enlargement not allowed |
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Inner Diameter |
± 25 % |
± 25 % |
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Flow Rate |
adjustment possible with change in column dimensions |
± 50% (exceedance allowed if column dimensions are changed) |
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Column Temperature |
± 5 °C (if working temperature specified and nothing else prescribed) |
± 10 °C (if working temperature specified and nothing else prescribed) |
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Injection Volume |
Reduction possible (provided detection and repeatability of the peak(s) to be determined are satisfactory); larger injection volume not allowed |
Reduction possible (provided detection and repeatability of the peak(s) to be determined are satisfactory), larger injection volume not allowed |
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pH Value of the Mobile Phase |
no adjustment allowed |
± 0.2 pH units, unless otherwise prescribed; |
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Salt Concentration of Buffer |
no adjustment allowed |
± 10 % |
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Composition of Mobile Phase |
Minor changes under following conditions:
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<± 30 % (rel.) or ± 2 % (abs.) for quantity of least abundant component; no other component may be changed by more than 10 % (abs.) |