New detectors continue to be developed in attempts to overcome the deficiencies of those being used. It is spherical, silica-based, and processed to provide pH stability. L48Sulfonated, cross-linked polystyrene with an outer layer of submicron, porous, anion-exchange microbeads, 15 m in diameter. Multi-wavelength detectors measure absorbance at two or more wavelengths simultaneously. There is no change to the calculation, and Empower currently reports USP Tailing (Figure 4). G14Polyethylene glycol (av. In partition chromatography the substances to be separated are partitioned between two immiscible liquids, one of which, the immobile phase, is adsorbed on a, The sample to be chromatographed is usually introduced into the chromatographic system in one of two ways: (a) a solution of the sample in a small volume of the mobile phase is added to the top of the column; or, (b) a solution of the sample in a small volume of the immobile phase is mixed with the. The bottom of the chamber is covered with the prescribed solvent system. mol. The apparatus for direct quantitative measurement on the plate is a densitometer that is composed of a mechanical device to move the plate or the measuring device along the. L27Porous silica particles, 30 to 50 m in diameter. However, many isomeric compounds cannot be separated. The ratio is made by dividing the total width by twice the front width. about 15,000). Supports and liquid phases are listed in the section. G12Phenyldiethanolamine succinate polyester. Allow the plates to remain undisturbed for 5 minutes, then transfer the square plates, layer side up, to the storage rack, and dry at 105, The adsorbent (such as activated alumina or silica gel, calcined diatomaceous silica, or chromatographic purified siliceous earth) as a dry solid or as a slurry is packed into a glass or quartz chromatographic tube. The paper section(s) predetermined to contain the isolated drug(s) may be cut out and eluted by an appropriate solvent, and the solutions may be made up to a known volume and quantitatively analyzed by appropriate chemical or instrumental techniques. The types of chromatography useful in qualitative and quantitative analysis that are employed in the USP procedures are column, gas, paper, thin-layer, (including high-performance thin-layer chromatography), and pressurized liquid chromatography (commonly called high-pressure or high-performance liquid chromatography). Data also may be collected on simple recorders for manual measurement or on stand-alone integrators, which range in complexity from those providing a printout of peak areas to those providing chromatograms with peak areas and peak heights calculated and data stored for possible subsequent reprocessing. 2. Acceptance criteria and analytical procedures used to estimate identified or unidentified impurities can be based on analytical assumptions (e.g., equivalent detector response). At higher pressures an injection valve is essential. G15Polyethylene glycol (av. 1 0 obj << /Producer (Acrobat Distiller 4.0 for Windows) /Creator (Microsoft Word 8.0) /ModDate (D:20000525143132-05'00') /Author (Patricia) /Subject (Evaluating System Suitability - CE, GC, LC and A/D ChemStation - Revisio\ ns: A.03.0x-->A.08.0x) /Title (Evaluating System Suitability - CE, GC, LC and A/D ChemStation - Revisio\ ns: A.03.0x-->A.08.0x) /CreationDate (D:20000525143057) >> endobj 2 0 obj << /Type /Pages /Kids [ 86 0 R 115 0 R 85 0 R ] /Count 17 >> endobj 4 0 obj << /Type /Catalog /Pages 2 0 R /OpenAction [ 5 0 R /XYZ null null null ] /PageMode /UseNone /PageLabels << /Nums [ -2 << /S /D /St -1 >> ] >> >> endobj 5 0 obj << /Type /Page /Parent 86 0 R /Resources 6 0 R /Contents 11 0 R /MediaBox [ 0 0 612 792 ] /CropBox [ 0 0 612 792 ] /Rotate 0 >> endobj 6 0 obj << /ProcSet [ /PDF /Text /ImageC /ImageI ] /Font << /TT2 8 0 R /TT4 12 0 R /TT6 15 0 R >> /XObject << /Im1 17 0 R >> /ExtGState << /GS1 18 0 R >> /ColorSpace << /Cs5 7 0 R /Cs9 9 0 R >> >> endobj 7 0 obj [ /CalRGB << /WhitePoint [ 0.9505 1 1.089 ] /Gamma [ 2.22221 2.22221 2.22221 ] /Matrix [ 0.4124 0.2126 0.0193 0.3576 0.71519 0.1192 0.1805 0.0722 0.9505 ] >> ] endobj 8 0 obj << /Type /Font /Subtype /TrueType /FirstChar 32 /LastChar 121 /Widths [ 222 0 0 0 0 0 0 0 0 0 0 0 222 222 222 222 407 407 407 0 407 0 0 407 0 0 222 0 0 0 0 0 0 463 0 426 0 0 0 0 481 204 0 0 0 648 519 0 426 0 0 0 407 0 0 685 0 0 0 0 0 0 0 0 0 371 389 333 389 371 241 389 389 167 0 371 167 611 389 389 389 0 259 315 259 389 352 611 0 371 ] /Encoding /WinAnsiEncoding /BaseFont /UniversLightCondensed /FontDescriptor 10 0 R >> endobj 9 0 obj [ /Indexed 7 0 R 255 16 0 R ] endobj 10 0 obj << /Type /FontDescriptor /Ascent 912 /CapHeight 0 /Descent -250 /Flags 32 /FontBBox [ -105 -250 857 912 ] /FontName /UniversLightCondensed /ItalicAngle 0 /StemV 0 >> endobj 11 0 obj << /Length 1169 /Filter /FlateDecode >> stream of Ivacaftor Injection No. L16Dimethylsilane chemically bonded to porous silica particles, 5 to 10 m in diameter. The effects of variability can be minimized by addition of an internal standard, a noninterfering compound present at the same concentration in test and standard solutions. G31Nonylphenoxypoly(ethyleneoxy)ethanol (av. For a perfectly Gaussian peak, the front half-width will be exactly half the entire peak width, so the tailing factor will be 1.0. . G442% low molecular weight petrolatum hydrocarbon grease and 1% solution of potassium hydroxide. Suitability requirements Standard solution: Solution of USP Zolpidem Tartrate Tailing factor: NMT 3.0 for zolpidem RS in Medium containing (L/500) mg/mL, where L is When As < 1.0, the peak is . Separation Science offers free learning from the experts covering methods, applications, webinars, eSeminars, videos, tutorials for users of liquid chromatography, gas chromatography, mass spectrometry, sample preparation and related analytical techniques. Silylating agents are widely used for this purpose and are readily available. A USP tailing factor (TF) of <2 Most scientists are reluctant to make any changes in the USP methods because they may have to re-validate the method (costly and time consuming procedure) . The wavelength accuracy of a variable-wavelength detector equipped with a monochromator should be checked by the procedure recommended by its manufacturer; if the observed wavelengths differ by more than 3 nm from the correct values, recalibration of the instrument is indicated. G48Highly polar, partially cross-linked cyanopolysiloxane. Resolution: One of the most important parameters. S1CA support prepared from crushed firebrick and calcined or burned with a clay binder above 900, S2Styrene-divinylbenzene copolymer having a nominal surface area of less than 50 m, S3Copolymer of ethylvinylbenzene and divinylbenzene having a nominal surface area of 500 to 600 m, S4Styrene-divinylbenzene copolymer with aromatic O and N groups, having a nominal surface area of 400 to 600 m. S540- to 60-mesh, high-molecular weight tetrafluorethylene polymer. retention time measured from time of injection to time of elution of peak maximum. G47Polyethylene glycol (av. Where the internal standard is chemically similar to the substance being determined, there is also compensation for minor variations in column and detector characteristics. mol. L19Strong cation-exchange resin consisting of sulfonated cross-linked styrene-divinylbenzene copolymer in the calcium form, about 9 m in diameter. As resolved compounds emerge separately from the column, they pass through a differential detector, which responds to the amount of each compound present. As peak asymmetry increases, integration, and hence precision, becomes less reliable. Fluorometric detectors are sensitive to compounds that are inherently fluorescent or that can be converted to fluorescent derivatives either by chemical transformation of the compound or by coupling with fluorescent reagents at specific functional groups. The subsequent flow of solvent moves the drug down the column in the manner described. HPLC systems are calibrated by plotting peak responses in comparison with known concentrations of a reference standard, using either an external or an internal standardization procedure. An innovative, straightforward, precise, accurate, reproducible, and efficient simultaneous equation method, or Vierordt's technique, was successfully developed for predicting Miconazole and. An alternative for the calculation of Plate Count is to create a Custom Field. - Tailing factor: NMT 2.5 - Relative standard deviation: NMT 2.0% Analysis: Calculate the percentage of the labeled amount of amoxicillin (C16H19N3O5S) in the portion of tablets for oral suspension taken: Result = (rU/rS) (CS/CU) P F 100 - Acceptance criteria: 90.0-110.0% Disintegration The new calculation uses peak widths at half height. L50Multifunction resin with reversed-phase retention and strong anion-exchange functionalities. The type of detector to be used depends upon the nature of the compounds to be analyzed and is specified in the individual monograph. In practice, separations frequently result from a combination of adsorption and partitioning effects. L43Pentafluorophenyl groups chemically bonded to silica particles by a propyl spacer, 5 to 10 m in diameter. What is USP tailing factor? Acceptance Criteria: Relative standard deviation for six replicate injections should be NMT 2%, a tailing factor NMT 2.0, and Theoretical plate count NLT 1000. To promote uniformity of interpretation, the following symbols and definitions are employed where applicable in presenting formulas in the individual monographs. For two-dimensional chromatography, dry the plates after the first development, and carry out a second development in a direction perpendicular to that of the first development. L11Phenyl groups chemically bonded to porous silica particles, 5 to 10 m in diameter. The elution time is a characteristic of an individual compound; and the instrument response, measured as peak area or peak height, is a function of the amount present. The drug principles are quantitatively removed from the solution and are adsorbed in a narrow transverse band at the top of the column. Columns may be heated to give more efficient separations, but only rarely are they used at temperatures above 60. System suitability must be demonstrated throughout the run by injection of an appropriate control preparation at appropriate intervals. G750% 3-Cyanopropyl-50% phenylmethylsilicone. Replicate injections of a standard preparation used in the assay or other standard solution are compared to ascertain whether requirements for precision are met. In some cases, values less than unity may be observed. S>1: Tailing peak S=1: Peak with Gaussian distribution (symmetry) S<1: Leading peak L37Packing having the capacity to separate proteins by molecular size over a range of 2,000 to 40,000 Da. Liquid stationary phases are available in packed or capillary columns. Analytical Method Validation as per ICH vs USP May. The tailing factor is determined by drawing a perpendicular line from the peak centre to the baseline of the peak. The capacity required influences the choice of solid support. L28A multifunctional support, which consists of a high purity, 100, L29Gamma alumina, reverse-phase, low carbon percentage by weight, alumina-based polybutadiene spherical particles, 5 m in diameter with a pore volume of 80. 14, 2017 71 likes 20,860 views Download Now Download to read offline Healthcare How analytical method validation differs between ICH and USP. wt. Peak areas are generally used but may be less accurate if peak interference occurs. These detectors are selective, sensitive, and reliable, but require conducting mobile phases free of dissolved oxygen and reducible metal ions. When As >1.0,thepeak is tailing. A high molecular weight compound of polyethylene glycol with a diepoxide linker. Baseline Noise: A Summary of Noise - Tip300, USP Chapter 621 for Chromatography: USP Requirements - Tip302. Clear plastic tubing made of a material such as nylon, which is inert to most solvents and transparent to short-wavelength UV light, may be packed with adsorbent and used as a chromatographic column. The. Then the peak width and the front half-width are measured for the peak at 5% of the height of the peak. In partition chromatography, the partition coefficient, and hence the separation, can be changed by addition of another component to the mobile phase. reproduce the necessary conditions and obtain results within the proposed acceptance criteria. The suitability test is accepted when the RSD values of these parameters are less than 2% (USP, 2009). Eclipse Business Media Ltd, Regd in England, No. Width at Tangent is no longer used for any calculation. G49Proprietary derivatized phenyl groups on a polysiloxane backbone. A major source of error is irreproducibility in the amount of sample injected, notably when manual injections are made with a syringe. wt. There are two main methods for defining peak tailing: Tailing factor (Tf) - widely used in the pharmaceutical industry. L38A methacrylate-based size-exclusion packing for water-soluble samples. Replicate injections of a standard preparation used in the assay or other standard solution are compared to ascertain whether requirements for precision are met. G1925% Phenyl-25% cyanopropyl-50% methylsilicone. . The distinguishing features of gas chromatography are a gaseous mobile phase and a solid or immobilized liquid stationary phase. 943 - 946. Whenever there is a significant change in equipment or in a critical reagent, suitability testing should be performed before the injection of samples. Assays require quantitative comparison of one chromatogram with another. L7Octylsilane chemically bonded to totally porous silica particles, 3 to 10 m in diameter. L62C30 silane bonded phase on a fully porous spherical silica, 3 to 15 m in diameter. L35A zirconium-stabilized spherical silica packing with a hydrophilic (diol-type) molecular monolayer bonded phase having a pore size of 150. L34Strong cation-exchange resin consisting of sulfonated cross-linked styrene-divinylbenzene copolymer in the lead form, about 9 m in diameter. They are used to verify that the. The USP requires that unless otherwise specified by a method: - if a relative standard deviation of <2% is required then five replicate injections should be For packed columns, the carrier gas flow rate is usually expressed in mL per minute at atmospheric pressure and room temperature. A flowing chromatogram, which is extensively used, is obtained by a procedure in which solvents are allowed to flow through the column until the separated drug appears in the effluent solution, known as the eluate. The drug may be determined in the eluate by titration or by a spectrophotometric or colorimetric method, or the solvent may be evaporated, leaving the drug in more or less pure form. L23An anion-exchange resin made of porous polymethacrylate or polyacrylate gel with quaternary ammonium groups, about 10 m in size. Specifically, in this tip, we look at the changes to the calculationsthat affect Empower. 127 You should also describe aspects of the analytical procedures that require special attention. Subscribe to our eNewsletter with daily, weekly or monthly updates: Food, Environmental, (Bio)Pharmaceutical, Bioclinical, Liquid Chromatography, Gas Chromatography and Mass Spectrometry. The tailing factor in HPLC is also known as the symmetry factor. mol. A polymethacrylate resin base, cross-linked with polyhydroxylated ether (surface contained some residual carboxyl functional groups) was found suitable. All rights reserved. The Current EP 6.0 guidance is defined in Section 2.2.46, Analytical Training Solutions Online Courses, https://www.linkedin.com/showcase/separation-science-/. Derivatize with the prescribed reagent, if necessary, and record the reflectance or fluorescence in the chromatograms obtained. G39Polyethylene glycol (av. Each sample application contains approximately the same quantity by weight of material to be chromatographed. Draw the spreader smoothly over the plates toward the raised end of the aligning tray, and remove the spreader when it is on the end plate next to the raised end of the aligning tray. The control preparation can be a standard preparation or a solution containing a known amount of analyte and any additional materials useful in the control of the analytical system, such as excipients or impurities. 2 USP: The United States Pharmacopeia, XX. STEP 4 Polymeric stationary phases coated on the support are more durable. L24A semi-rigid hydrophilic gel consisting of vinyl polymers with numerous hydroxyl groups on the matrix surface, 32 to 63 m in diameter. Flow rate: 1.5 mL/min Acceptance criteria: Meet the requirements Injection size: 10 L System suitability IMPURITIES Samples: Standard solution ORGANIC IMPURITIES Suitability requirements Solution A, Solution B, Mobile phase, System suitabil-Tailing factor: NMT 2.0 ity solution, Sample solution, and Chromatographic No sample analysis is acceptable unless the requirements of system suitability have been met. The sensitivity increases with the number and atomic weight of the halogen atoms. A high molecular weight compound of a polyethylene glycol and a diepoxide that is esterified with terephthalic acid. L2Octadecyl silane chemically bonded to silica gel of a controlled surface porosity that has been bonded to a solid spherical core, 30 to 50 m in diameter. Fixed, variable, and multi-wavelength detectors are widely available. STEP 1 L53Weak cation-exchange resin consisting of ethylvinylbenzene, 55% cross-linked with divinylbenzene copolymer, 3 to 15 m diameter. It exhibits an extremely high response to compounds containing halogens and nitro groups but little response to hydrocarbons. Peak areas and peak heights are usually proportional to the quantity of compound eluting. Reagents used with special types of detectors (e.g., electrochemical, mass spectrometer) may require the establishment of additional tolerances for potential interfering species. L14Silica gel having a chemically bonded, strongly basic quaternary ammonium anion-exchange coating, 5 to 10 m in diameter. L52A strong cation exchange resin made of porous silica with sulfopropyl groups, 5 to 10 m in diameter. When an analyte enters the detector with the carrier gas, the difference in thermal conductivity of the gas stream (carrier and sample components) relative to that of a reference flow of carrier gas alone is measured. mol. The thermal conductivity detector employs a heated wire placed in the carrier gas stream. Reliable quantitative results are obtained by external calibration if automatic injectors or autosamplers are used. Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques. For capillary columns, linear flow velocity is often used instead of flow rate. mol. (Wash away all traces of adsorbent from the spreader immediately after use.) Fixed wavelength detectors operate at a single wavelength, typically 254 nm, emitted by a low-pressure mercury lamp. The spotted chromatographic sheet is suspended in the chamber by use of the antisiphon rod, which holds the upper end of the sheet in the solvent trough. Selective elution of the components of a mixture can be achieved by successively changing the mobile phase to one that provides a more favorable partition coefficient, or by changing the pH of the immobile phase. 10. If a fluorescent adsorbent is used, the column may be marked under UV light in preparation for slicing. Remember that any Custom Field should be validated before putting it into routine use (Figure 3). System suitability Medium, Apparatus, and Times: Proceed as directed Sample: Standard solution for Test 1. of 3000 to 3700). These changes are being made to harmonize the calculations with the European Pharmacopoeia (EP) and the Japanese Pharmacopoeia (JP). The U.S. Pharmacopeia (USP) has also recommended measuring tailing factor (T) as the back-to-front ratio of a bisected peak measured at 5% of height. 3.5 Tailing factor T This is a measure for the asymmetry of the peak. This can be done with either the Pro or QuickStart interface. Since the natural water content of the paper, or selective imbibition of a hydrophilic component of the liquid phase by the paper fibers, may be regarded as a stationary phase, a partitioning mechanism may contribute significantly to the separation. Complete the application of adsorbents using plaster of Paris binder within 2 minutes of the addition of the water, because thereafter the mixture begins to harden. This can be done with either the Pro or QuickStart interface. Likewise, relative resolution will be calculated using peak widths at half height. The FDA's "Guidance for Reviewers" of HPLC methods. Unless otherwise directed in the monograph, system suitability parameters are determined from the analyte peak. Particles are usually 3 to 10 m in diameter, but sizes may range up to 50 m or more for preparative columns. Partitioning is the predominant mechanism of separation in gasliquid chromatography, paper chromatography, in forms of column chromatography and in thin-layer chromatography designated as liquid-liquid separation. If syringe injection, which is irreproducible at the high pressures involved, must be used, better quantitative results are obtained by the internal calibration procedure where a known amount of a noninterfering compound, the internal standard, is added to the test and reference standard solutions, and the ratios of peak responses of drug and internal standard are compared. A modified procedure for adding the mixture to the column is sometimes employed. Because of normal variations in equipment, supplies, and techniques, a system suitability test is required to ensure that a given operating system may be generally applicable. Tailing factor: It should meet the requirements of the individual monograph and can be calculated by following formula: T = W 0.05 2F W0.05 = Peak width at 5% high F = Leading edge of the peak Theoretical Plates: The number of Theoretical Plate represents the column efficiency. about 1500). of 950 to 1050). Place the plate in the chamber, ensuring that the plate is as vertical as possible and that the spots or bands are above the surface of the mobile phase, and close the chamber. USP Tailing and Symmetry Factor per both the EP and JP. G3220% Phenylmethyl-80% dimethylpolysiloxane. A stability-indicating HPLC technique . Specific and pertinent chemical, spectroscopic, or physicochemical identification of the eluted component combined with chromatographic identity is the most valid criterion of identification. Chromatographic purity tests for drug raw materials are sometimes based on the determination of peaks due to impurities, expressed as a percentage of the area due to the drug peak. Columns used for analytical separations usually have internal diameters of 2 to 5 mm; larger diameter columns are used for preparative chromatography. . wt. Those used for analysis typically are porous polymers or solid supports with liquid phase loadings of about 5% (w/w). L17Strong cation-exchange resin consisting of sulfonated cross-linked styrene-divinylbenzene copolymer in the hydrogen form, 7 to 11 m in diameter. Empower currently reports relative resolution using peak widths at half height for USP, EP, and JP. S10A highly polar cross-linked copolymer of acrylonitrite and divinylbenzene. In ascending chromatography, the lower edge of the sheet (or strip) is dipped into the mobile phase to permit the mobile phase to rise on the chromatographic sheet by capillary action. Unless otherwise directed in the monograph, system suitability parameters are determined from the analyte peak. 254 Evaluating System Suitability General Definitions General Definitions Void Volume where: d = diameter of column [cm] = constant, ratio of circumference to diameter of a circle 0 and to determine the number of theoretical plates. In conventional liquid-liquid partition chromatography, the degree of partition of a given compound between the two liquid phases is expressed by its partition or distribution coefficient. Replicate injections of the standard preparation required to demonstrate adequate system precision may be made before the injection of samples or may be interspersed among sample injections. L46Polystyrene/divinylbenzene substrate agglomerated with quaternary amine functionalized latex beads, about 10 m in diameter. Revision, pp. It is represented in equation (5) based on the measurements shown in Fig. Enter the email address you signed up with and we'll email you a reset link. R.A. van Iterson Drenthe College Emmen Holland for www.standardbase.com . The LCMS-MS chromatograms of ABT and DCF are given in Fig. The use of temperature-programmable column ovens takes advantage of this dependence to achieve efficient separation of compounds differing widely in vapor pressure. width of peak measured by extrapolating the relatively straight sides to the baseline. L40Cellulose tris-3,5-dimethylphenylcarbamate coated porous silica particles, 5 to 20 m in diameter. wt. The pH of the mobile phase, temperature, ion type, ionic concentration, and organic modifiers affect the equilibrium, and these variables can be adjusted to obtain the desired degree of separation. hb```y,k@( System suitability tests are an integral part of gas and liquid chromatographic methods. Empower currently reports EP Plate Count and JP Plate Count, both of which use peak width at half height (Figure 3). Specific requirements for chromatographic procedures for drug substances and dosage forms, including adsorbent and developing solvents, are given in the individual monographs. Packed columns, made of glass or metal, are 1 to 3 m in length with internal diameters of 2 to 4 mm. Unless otherwise specified in the individual monograph, flow rates for packed columns are about 30 to 60 mL per minute. Peak asymmetry = B/A, and peak tailing factor = (A + B)/2A. In size-exclusion chromatography, columns are packed with a porous stationary phase. If the substance to be identified and the authentic specimen are identical, all chromatograms agree in color and. If the separated compounds are colored or if they fluoresce under UV light, the adsorbent column may be extruded and, by transverse cuts, the appropriate segments may then be isolated. EP Plate Count and JP Plate Count use peak width at half height. . L12A strong anion-exchange packing made by chemically bonding a quaternary amine to a solid silica spherical core, 30 to 50 m in diameter. In paper chromatography the adsorbent is a sheet of paper of suitable texture and thickness. Unless otherwise specified in the individual monograph, data from five replicate injections of the analyte are used to calculate the relative standard deviation, These tests are performed by collecting data from replicate injections of standard or other solutions as specified in the individual monograph. After this equilibrium has been established, the injector automatically introduces a fixed amount of the headspace in the sample container into the gas chromatograph. L49A reversed-phase packing made by coating a thin layer of polybutadiene onto spherical porous zirconia particles, 3 to 10 m in diameter. Is there a generally accepted pharmaceutical cGMP industry standard for the limits on system suitability criteria? High-capacity columns, with liquid phase loadings of about 20% (w/w), are used for large test specimens and for the determination of low molecular weight compounds such as water. Figure 2. Other separation principles include ion exchange, ion-pair formation, size exclusion, hydrophobic interaction, and chiral recognition. For maximum flexibility in quantitative work, this range should be about three orders of magnitude. Refractive index detectors are used to detect non-UV absorbing compounds, but they are less sensitive than UV detectors. Usually 30 g of adsorbent and 60 mL of water are sufficient for five 20- 20-cm plates. Arrange the plate or plates on the aligning tray, place a 5- 20-cm plate adjacent to the front edge of the first square plate and another 5- 20-cm plate adjacent to the rear edge of the last square, and secure all of the plates so that they will not slip during the application of the adsorbent. The half-height multiplier changes from 5 to 20 for both USP and EP (Figure 5). The efficiency of the separation may be checked by obtaining a thin-layer chromatogram on the individual fractions. 105 106 Plate height (H) (synonym: Height equivalent to one theoretical plate (HETP)) 107 Ratio of the column length (L), in micrometers, to the plate number (N): 108 H = 109 110 111 Plate number (N) (synonym: Number of theoretical plates) Injection size: 15 L beling indicates that it meets USP Dissolution Test 2. EFFECTIVE DATE 04/29/2016. Tailing Factor will be called Symmetry Factor. Symmetry factor (S, also called "tailing factor") is a coefficient that shows the degree of peak symmetry.
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