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YMC HPLC Columns Applications Notebook

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WA30000 HPLC Columns Applications Notebook Table of Contents Click on the items below to go directly to that section of the notebook. To Start a new search, click on Table of Contents Bookmark to the left YMC™ HPLC Column Quality Assurance............................................................2 Guide to YMC™ Part Numbering System ...........................................................3 YMC™ Column Selection Guide ....................................................................4-7 HPLC Troubleshooting and Reference Guide..................................................8-14 List of Applications..................................................................................15-20 1. Vitamins .....................................................................................21 2. Carbohydrates ............................................................................32 3. Nucleic Acids .............................................................................43 4. Amino Acids, Peptides, Proteins......................................................48 5. Organic Acids, Fatty Acid Derivatives .............................................60 6. Food Additives ............................................................................62 7. Natural Products ..........................................................................68 8. Steroids......................................................................................77 9. Drugs, Metabolites .......................................................................87 10. Antibiotics.................................................................................103 11. Pesticides, Environmental .............................................................114 12. Miscellaneous ...........................................................................119 Index of Analytes.......................................................................................128 1 YMC™ HPLC Column Quality Assurance Waters Establishes Worldwide Distribution Network for YMC™ HPLC Columns Waters Corporation announces worldwide distribution of the YMC™ HPLC A Product You Can Count On analytical and preparative column lines, a highly respected series of prod- ™ ucts that Waters has distributed since 1997. In expanding the distribution YMC products must pass internal performance criteria as raw materials, of YMC™ columns globally, Waters maintains exclusive distribution rights as synthesized silica particles, after they are bonded, and finally when for the YMC™ column product line in the Americas (North America, Central they are packed into a column. By setting tight standards, testing the raw America, South America and the Caribbean Islands). materials and precise control of silica gel synthesis, low metal levels of puri- ty are achieved. Acceptance standards virtually eliminate problems with YMC...a Premium HPLC Packing Manufacturer nonspecific adsorption caused by trace contaminants in the silica gel. YMC has built its reputation on the supply of consistent, premium quality HPLC packing and columns. Control of the silica support is essential for product consistency and is of the highest priority to YMC. The silica sup- ports are then functionalized with the Company’s proprietary bonding and endcapping chemistries to yield rugged, reproducible, high performance HPLC packings. Consistent Production Methods Year to Year Once a YMC product has been provided to customers for their chro- matography, the methods used to produce that product will not be changed, as a matter of company policy. Even small changes in manu- facturing methods to “improve” a product can lead to selectivity changes in methods for which that column is applied. Because YMC controls the pro- duction of its products from silica synthesis to packed column you can be assured that a method developed on a YMC™ column will be reproducible for as long as you conduct that method. In-house manufacture gives YMC complete control over product quality and reproducibility. Proven procedures at every stage of manufacture guaran- tee consistency in silica purity, particle size, pore size, bonding and end- capping. Test chromatograms shipped with every column are merely the YMC-Pack™ Pro C18™ columns come with a detailed Certificate of final demonstration of a rigorously controlled product. Analysis for reliability and traceability. US Pharmacopeia HPLC "L1" (C18) Column Designation Subclassification Testing by Brand Name* Hydrophobicity Chelating Silanol Activity Shape Selectivity Column Brand Name (k, Ethylbenzene) (Tailing Factor (TF), Quinizarin) (k, Amitriptyline) (TF, Amitriptyline) (Bonding Density, mmol/m2) Pro C18™ 1.88 1.28 4.74 1.50 2.50 ™ Hydrosphere C18 1.52 1.34 4.40 1.94 1.90 Pro C18™ RS 3.28 1.17 7.50 1.35 3.04 ODS-AL™ 1.79 1.52 13.59 2.81 2.56 ODS-A™ 1.89 1.53 5.00 2.40 2.66 ODS-AM™ 1.94 1.52 5.11 2.40 2.75 ODS-AQ™ 1.88 1.49 5.96 2.86 2.22 J’sphere™ ODS-H80 3.32 1.31 8.80 2.93 3.18 J'sphere™ ODS-M80 1.62 1.41 4.96 2.72 1.02 J’sphere™ ODS-L80 0.95 1.43 2.94 2.78 0.92 * For use in C18 Column Brand Name selection when referencing USP Monographs which specify the characteristics/performance of the C18 Column used in the method. Choose a brand as close as possible to the referenced column values for the best chance of duplicating the analytical results of the method. 2 © 2003 Waters Corporation.Waters is a trademark of Waters Corporation. YMC ™ is a trademark of YMC ™ , Co.,Ltd Guide to YMC™ Part Numbering System Guide to YMC™ Part Numbering System The YMC™ part numbering system is designed to help identify the product length, and column inner diameter. These are followed by fitting codes for being ordered. This system: internal use by Waters. The system is set out schematically below: •embeds in the part number a description of the product that can be read by the user; Gel Code Hardware Code • standardizes the YMC™ part numbers worldwide; and, Chemistry Pore Size in Particle Particle size Length Internal Code nm Shape in µm in mm diameter in mm • simplifies computerized stocking and ordering. The table below will enable you to “read” your part numbers, and confirm Example: a semipreparative column with the part number that a part number you are about to use for ordering is exactly what you “OC12S052520WT” is in your stock. “Read” the part number as need. This should reduce ordering errors that can delay delivery of the cor- OC/12/S/05/25/20, and you can determine that this column is: rect column. Octyl 12nm (120Å) Spherical 5 µm 25 cm 20 mm I.D. (C8) pores media particles long Gel Code & Hardware Code The part numbers are composed of a gel code, which describes the pack- Please do not use this table to write your own part numbers. Certain attrib- ing in the HPLC column, and the hardware code, which describes the col- utes that are available in some stationary phases are not available umn itself. The gel and hardware codes are further divided into short codes in others. If you are unsure of a part number, please check the catalog or that describe the chemistry, pore size, particle shape, particle size, column price list, ask your technical representative directly to confirm availability. Chemistry Code Pore Size in Angstroms Particle Shape Particle Size in µm Length in mm Internal Diameter in mm ODS-A™:AA60Å: 06 Spherical: S 3 µm: 03 10 mm: 01 0.2 mm: G0 ODS-AM™:AM80Å: 08 Irregular: I 4 µm: 04 20 mm: 02 0.3 mm: H0 ODS-AQ™:AQ120Å: 12 5 µm: 05 23 mm: G3 0.5 mm: J0 ODS-AL™:AL200Å: 20 6 µm: 06 30 mm: 03 1.0 mm: 01 PolymerC18™:PC300Å: 30 5/15 µm (10P): 11 33 mm H3 2.0 mm: 02 J’sphere™ ODS-H80: JH 1000Å A0 15 µm: 15 50 mm: 05 3.0 mm: 03 J’sphere™ ODS-M80: JM Proprietary or 10/20 µm: 16 75 mm: L5 4.0 mm: 04 J’sphere™ ODS-L80: JL unspecified: 99 15/30 µm: 21 100 mm: 10 4.6 mm: 46 YMCbasic™:BA 30/50 µm: 41 150 mm: 15 6.0 mm: 06 Octyl (C8): OC 50 µm: 50 250 mm: 25 8.0 mm: 08 Phenyl: PH 75 µm: 75 300 mm: 30 10 mm: 10 Butyl (C4): BU 150 µm: A5 500 mm: 50 20 mm: 20 TMS (C1): TM 350 µm: C5 1000 mm: A0 30 mm: 30 Cyano: CN Undesignated: 99 1500 mm: A5 50 mm (1000psi): 51 Amino: NH 2000 mm: B0 50 mm (2000psi): 52 PA-gel™:PA Irregular: 70 mm (1000psi): 71 Polyamine II: PB 5/20 µm: 12 70 mm (2000psi): 72 Silica: SL 10/25 µm: 17 100 mm (1000psi): A1 PVA-Sil™:PV 10/40 µm: 25 100 mm (2000psi): A2 Diol (NP): DN 25/40 µm: 32 150 mm (1000psi): B1 Diol (SEC): DL 40/63 µm: 52 150 mm (2000psi): B2 Protein-RP™:PR 63/210 µm: A4 200 mm (1000psi): C1 Pro C4 BS Pro C8 OS Pro C18™ AS 200 mm (2000psi): C2 Cartenoid CT Pro C18RS™ RS ™ Hydrosphere C18 HS © 2003 Waters Corporation.Waters is a trademark of Waters Corporation. YMC™ is a trademark of YMC™, Co.,Ltd. 3 YMC™ Column Selection Guide Choosing an HPLC Column YMC-Pack™ High Performance HPLC Columns High Performance Silica Supports YMC™ provides an extensive selection of packed columns to address your Spherical packing for long column life: YMC™ spherical packing pro- separation needs. Numerous specialty bonded phases are available to vides high performance with long column lifetimes. Spherical particles pack solve the most difficult separation problems. more uniformly than “spheroidal” or irregular supports. The greater mechan- ical stability of the column bed eliminates premature voiding. • Extensive selection of bonded phases available in five different porosities High surface area: The ultrapure YMC™ spherical supports have very high porosity, providing increased surface area for greater retention and • Column diameters from microbore to process scale increased resolution. In preparative
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    ÎÇÊ*/Ê >iÀ £ÉÓ»Ê*ÀÌ>LiÊ À`iÀ £{Ê*/ -ÕL i>`}Ê B Active™ 2[X]XRP[0__[XRPcX^]b UÊ-Õ««ÀÌÊi>Ì ÞÊ,iëÃiÊÌÊ-ÌÀiÃÃÊ>`Ê>Ì}Õi UÊ-Õ««ÀÌÊ >ÀL Þ`À>ÌiÊiÌ>LÃÉ*ÃÃLÞÊ,i`ÕViÊ Ã ÎÉ{»Ê À`iÀ UÊ-Õ««ÀÌÊi>Ì ÞÊ iÀÛÕÃÊ-ÞÃÌiÉ`Ài>ÊÉÕiÊÕVÌ £ä*/Ê iÊ*ÕV ià UÊ-Õ««ÀÌÊi>Ì ÞÊÀiÊ >>Vi ÌiÌÊ Ý UÊ-Õ««ÀÌÊ >À`Û>ÃVÕ>ÀÊi>Ì Ê­VÕ`}ÊL`ÊViî Adbb2P]UXT[S<3 UÊ-Õ««ÀÌÊ }ÌÊ>`Êi>Ì ÞÊ` $$&($& B Active™ contains the entire spectrum of B vitamins to support a very wide range of bodily and stress-related functions. It features activated forms of vitamins B2, B6 and B12, with the addition of Benfotiamine, a patented, safe, fat-soluble, more physiologically-active form of thiamin.* BP]cP5T=<'&$& %%0eT]XSP0[STP All 360 Medicine® Formulas Meet or Exceed cGMP quality Standards 3XbRdbbX^] / iÊÜ>ÌiÀÃÕLiÊ ÊÛÌ>ÃÊ >ÛiÊÌÊLiÊ>LÃÀLi`ÊÊÌ iÊÃ>ÊÌiÃÌiÊ>`ÊÌ iÊ}ÊÌÊÌ iÊÛiÀÊÜ iÀiÊ Ì iÞÊ>ÀiÊLÌÀ>ÃvÀi`ÊÌÊÌ iÀÊ>VÌÛiÊViâÞiÊvÀðÊ>ÃÌÀÌiÃÌ>Ê>`ÉÀÊ i«>ÌVÊ«>ÀiÌÊ ÃÊiÞÊÌÊ>vviVÌÊ>LÃÀ«ÌÊ>`ÊÌ iÊ>VÌÛ>ÌÊ«ÀViÃðÊ*>Ã>Ê«ÞÀ`Ý>Êx½Ê« ë >ÌiÊ­*x*®ÊiÛiÃÊÜiÀiÊ vÕ`ÊÌÊLiÊÃ}vV>ÌÞÊÜiÀÊÌ >ÊÀ>ÊÊÓÓÊÕÌÊvÊΣʫ>ÌiÌÃÊÜÌ Ê«>Ài`ÊÛiÀÊvÕVÌ°£ ÊVÌÛiÊVÌ>ÃÊÛÌ>ÃÊ £]Ê Ó]Ê È]Ê>`Ê £ÓÊÊÌ iÀÊ« ÞÃ}V>Þ>VÌÛiÊvÀÊ>}ÊÌ iÊi>ÃiÀÊ ÌÊ >LÃÀLÊ >`Ê ºÀi>`ÞvÀÕÃi»°Ê ÀÊ iÝ>«i]Ê Ê «>ÌiÌÃÊ ÀiViÛ}Ê «ÞÀ`ÝiÊ ]Ê ÞÊ ÎÎÊ «iÀViÌÊ Àië`i`ÊÜÌ Ê>ÊVÀi>ÃiÊÊ«>Ã>Ê*x*ÆÊ ÜiÛiÀ]ÊÌ iÊiÛiÊVÀi>Ãi`ÊÊ>ÊvÊÌ iÊ«>ÌiÌÃÊÀiViÛ}Ê *x*°£ B Active™ *iÀ >«ÃÊ Ì iÊ ÃÌÊ ÌiÀiÃÌ}Ê }Ài`iÌÊ Ê Ì ÃÊ vÀÕ>Ê ÃÊ ivÌ>iÊ ­-LiâÞÌ >i "« ë >Ìi®]Ê>ÊÃ>vi]Êv>ÌÃÕLiÊ>>}ÊvÊÌ >iÊÌ >ÌÊÌÊÞÊÀ>ÃiÃÊL`Ê>`ÊÌÃÃÕiÊiÛiÃÊvÊ Ì >iÊ>ÌÊi>ÃÌÊvÛiÊÌiÃÊ } iÀÊÌ >ÊÌ iÊÜ>ÌiÀÃÕLiÊÃ>Ì]ÊLÕÌÊ>ÃÊÀi>ÃÊL>Û>>LiÊ>vÌiÀÊÌ iÊÀ>Ê >`ÃÌÀ>ÌÊÕ«ÊÌÊΰÈÊÌiÃÊ}iÀÊÌ >ÊÌ >iÊÃ>Ì°ÓÊ
  • Drug–Drug Salt Forms of Ciprofloxacin with Diflunisal and Indoprofen

    Drug–Drug Salt Forms of Ciprofloxacin with Diflunisal and Indoprofen

    CrystEngComm View Article Online COMMUNICATION View Journal | View Issue Drug–drug salt forms of ciprofloxacin with diflunisal and indoprofen† Cite this: CrystEngComm,2014,16, 7393 Partha Pratim Bag, Soumyajit Ghosh, Hamza Khan, Ramesh Devarapalli * Received 27th March 2014, and C. Malla Reddy Accepted 12th June 2014 DOI: 10.1039/c4ce00631c www.rsc.org/crystengcomm Two salt forms of a fluoroquinolone antibacterial drug, Crystal engineering approach has been effectively ciprofloxacin (CIP), with non-steroidal anti-inflammatory drugs, utilized in recent times in the synthesis of new forms particu- diflunisal (CIP/DIF) and indoprofen (CIP/INDP/H2O), were synthe- larly by exploiting supramolecular synthons. Hence the sized and characterized by PXRD, FTIR, DSC, TGA and HSM. Crystal identification of synthons that can be transferred across Creative Commons Attribution-NonCommercial 3.0 Unported Licence. structure determination allowed us to study the drug–drug different systems is important. For example, synthon trans- interactions and the piperazine-based synthon (protonated ferability in cytosine and lamivudine salts was recently dem- piperazinecarboxylate) in the two forms, which is potentially useful onstrated by Desiraju and co-workers by IR spectroscopy for the crystal engineering of new salt forms of many piperazine- studies.20a Aakeröy and co-workers successfully estab- based drugs. lished the role of synthon transferability (intermolecular amide⋯amide synthons) in the assembly and organization of Multicomponent pharmaceutical forms consisting of an bidentate acetylacetonate (acac) and acetate “paddlewheel” active pharmaceutical ingredient (API) and an inactive 20b complexes of a variety of metal(II)ions. Recently Das et al. co-former,whichisideallyagenerally recognized as safe – have reported the gelation behaviour in various diprimary This article is licensed under a 1 3 (GRAS) substance, have been well explored in recent times.
  • CLINICAL PHARMACOLOGY and BIOPHARMACEUTICS REVIEW(S) NDA 22561 Clinical Pharmacology Amendment Memo

    CLINICAL PHARMACOLOGY and BIOPHARMACEUTICS REVIEW(S) NDA 22561 Clinical Pharmacology Amendment Memo

    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022561Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) NDA 22561 Clinical Pharmacology Amendment Memo NDA Number: 22561 Submission Date: May 30, 2018 Submission Type: Standard Brand Name: Mavenclad Generic Name: Cladribine Dosage Form and Strength: Tablets, 10 mg Route of Administration: Oral Proposed Indication: Treatment of Relapsing forms of Multiple Sclerosis (RMS) Applicant: EMD Serono, Inc. OCP Review Team: Hristina Dimova, Ph.D., Angela Men, M.D., Ph.D., Mehul Mehta, Ph.D. This review is an amendment of the NDA 22561 review for Mavenclad, (cladribine in DARRTS on March 13, 2019) focusing on a new proposed Post-marketing Requirement (PMR). Background of Metabolism and in-vitro studies results: Cladribine is not a substrate of cytochrome P450 enzymes and does not show significant potential to act as inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4. Cladribine has no clinically meaningful inductive effect on CYP1A2, CYP2B6 and CYP3A4 enzymes. Transporter Systems: Cladribine is a substrate of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), equilibrative nucleoside transporter 1 (ENT1) and concentrative nucleoside transporter 3 (CNT3). New PMR: Conduct a clinical drug-drug interaction (DDI) study to evaluate the effect of cladribine on the pharmacokinetics (PK) of oral contraceptives. Include an evaluation of the effect on the components ethinyl estradiol (EE) and norelgestromin (NGMN). Rationale: No in vivo DDI study has been conducted to evaluate the effect of cladribine on systemically acting hormonal contraceptives. Currently it is unknown whether cladribine may reduce the effectiveness of hormonal contraceptives. Considering the in vitro study results described in Section 3.3.3.
  • Hazard Assessment of Glycyrrhizic Acid from Liquorice

    Hazard Assessment of Glycyrrhizic Acid from Liquorice

    VKM Report 2018: 09 Hazard assessment of glycyrrhizic acid from liquorice Opinion of the Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics of the Norwegian Scientific Committee for Food and Environment Report from the Norwegian Scientific Committee for Food and Environment (VKM) 2018: 09 Hazard assessment of glycyrrhizic acid from liquorice Opinion of Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics of the Norwegian Scientific Committee for Food and Environment 08.05.2018 ISBN: 978-82-8259-306-9 ISSN: 2535-4019 Norwegian Scientific Committee for Food and Environment (VKM) Po 4404 Nydalen N – 0403 Oslo Norway Phone: +47 21 62 28 00 Email: [email protected] vkm.no vkm.no/English Cover photo: ColourBox Suggested citation: VKM, Inger-Lise Steffensen, Gro Haarklou Mathisen, Ellen Bruzell, Berit Brunstad Granum, Jens Rohloff, Ragna Bogen Hetland (2018) Hazard assessment of glycyrrhizic acid from liquorice. Opinion of the Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics. ISBN: 978-82-8259-306-9. Norwegian Scientific Committee for Food and Environment (VKM), Oslo, Norway. VKM Report 2018: 09 Hazard assessment of glycyrrhizic acid from liquorice Preparation of the opinion The Norwegian Scientific Committee for Food and Environment (Vitenskapskomiteen for mat og miljø, VKM) appointed a project group to answer the request from the Norwegian Food Safety Authority. The project group consisted of two VKM members of the Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics and a project leader from the VKM secretariat.