The monograph below became official on May 1, 2025.
According to the United States Pharmacopeia and the National Formulary Pharmacopeial Forum (PF 47(3)*), "IMPURITIES: Limit of Urea" for "Fluorouracil Injection" should be carried out with a column filled with L39 packing material. The OHpak SB-802.5 HQ, a column filled with L39 packing material, confirmed the requirements were met.
System suitability requirementsRelative standard deviation (RSD) (Standard solution): ≤ 3.0 %
Tailing factor of urea (Standard solution): ≤ 2.0
*The version at the time of the application acquisition.
Sample: 50 μL
(Standard solution) Urea 0.5 mg/mL in eluent
- Column
- ：Shodex OHpak SB-802.5 HQ (8.0 mm I.D. x 300 mm)
- Eluent
- ：12.7 g/L of sodium nitrate with 0.1%(v/v) of triethylamine in water
- Flow rate
- ：0.8 mL/min
- Detector
- ：RI (45 ℃)
- Column temp.
- ：35 ℃
Sample Name Index
Operation Manual / Certificate of Analysis
Operation Manuals and Certificate of Analysis / Inspection Certificate for the following products can be downloaded here.
Product Name Index
Applications
- Analysis of Erythropoietin According to EP Method (LW-803)
- Analysis of Somatropin According to EP Method (LW-803)
- Analysis of Teriparatide According to EP Method (KW-802.5)
- Analysis of myo-Inositol According to EP Method (SC1011-7F)
- Analysis of Ethylcellulose Dispersion Type B According to USP-NF Method (KF-802)
- Analysis of Azithromycin According to USP-NF Method (ODP-50 4E)
- Analysis of Azithromycin for Injection According to USP-NF Method (ODP-50 4D)
- Analysis of Ascorbic Acid Injection According to USP-NF Method (DM-614)
- Analysis Alanine and Aspartic Acid According to USP-NF Method (SH1011)
- Analysis of Insulin According to USP-NF GENERAL CHAPTERS "<121.1> PHYSICOCHEMICAL ANALYTICAL PROCEDURES FOR INSULINS" (KW-802.5)
- Analysis of Exenatide Injection According to USP-NF Method (KW-802.5)
- Analysis of Epoetin According to USP-NF Method (LW-803)
- Analysis of Omega-3 Free Fatty Acids According to USP-NF Method (KF-802.5 + KF-802 + KF-801)
- Analysis of Xylitol According to USP-NF Method (SP0810)
- Analysis of Guar Gum According to USP-NF Method (SP0810)
- Analysis of Cranberry Fruit Juice According to USP-NF Method (SC1011-7F)
- Analysis of Zanamivir According to USP-NF Method (NH2P-50 4E)
- Analysis of Cefepime for Injection According to USP-NF Method (YK-421)
- Analysis of Sorbitol According to USP-NF Method (SP0810 8C)
- Analysis of Tagatose According to USP-NF Method (SC1011)
- Analysis of Dextrose According to USP-NF Method (SC1011)
- Analysis of Trehalose According to USP-NF Method (KS-801)
- Analysis of Pamidronate Disodium According to USP-NF Method (IC I-524A)
- Analysis of Betadex Sulfobutyl Ether Sodium According to USP-NF Method (SB-803 HQ)
- Analysis of Polyethylene Glycol 3350 According to USP-NF Method (2) (SB-803 HQ)
- Analysis of Polyethylene Glycol 3350 According to USP-NF Method (SB-802.5 HQ)
- Analysis of Polyethylene Glycol 3350 for Oral Solution According to USP-NF Method (SB-802.5 HQ)
- Analysis of Voriconazole According to USP-NF Method (CDBS-453)
- Analysis of Maltitol and Maltitol Solution According to USP-NF Method (SP0810 8C)
- Analysis of Maltose According to USP-NF Method (KS-801)
- Analysis of Propylene Glycol Monocaprylate According to USP-NF Method (KF-801)
- Analysis of Lamivudine According to USP-NF Method (CDBS-453)
- Analysis of Ribose According to USP-NF Method (KS-801)
- Analysis of Calcium Acetate Capsules According to USP-NF Method (YK-421)
- Analysis of Zinc Sulfate Compounded Injection According to USP-NF Method (YK-421)
- Analysis of Ibandronate Sodium According to USP-NF Method (I-524A)
- Analysis of Mannitol Compounded Injection According to USP-NF Method (SP0810)
- Analysis of Potassium Bicarbonate and Potassium Chloride Effervescent Tablets for Oral Solution According to USP-NF Method (YK-421)
- Analysis of Potassium and Sodium Bicarbonates and Citric Acid Effervescent Tablets for Oral Solution According to USP-NF Method (YK-421)
- Analysis of Glyceryl Stearate According to USP-NF Method (KF-802)
- Analysis of Glyceryl Distearate According to USP-NF Method (KF-802)
- Analysis of Glyceryl Tristearate According to USP-NF Method (KF-802)
- Analysis of Glyceryl Monooleate According to USP-NF Method (KF-802)
- Analysis of Glyceryl Monolinoleate According to USP-NF Method (KF-802)
- Analysis of Low Molecular Weight Heparin According to USP-NF GENERAL CHAPTERS ”<209> Low Molecular Weight Heparin Molecular Weight Determinations" (KW-803 + KW-802.5)
- Analysis of PMMA According to USP-NF GENERAL CHAPTERS ”<314> Molecular Weight Determination for Copolymers Containing Alkyl Methacrylate or Alkyl Acrylate" (LF-804)
- Analysis of Erythritol in According to USP-NF Method (SH1011)
- Analysis of Malic Acid According to USP-NF Method (SH1011)
- Analysis of Polydextrose According to USP-NF Method (SH1011)
- Analysis of Polydextrose According to USP-NF Method (2) (SB-804 HQ)
- Analysis of Hydrogenated Polydextrose According to USP-NF Method (SH1011)
- Analysis of Hydrogenated Polydextrose According to USP-NF Method (2) (SB-804 HQ)
- Analysis of Azithromycin Hydrate According to JP Method (ODP-50 4E)
- Analysis of Alendronate Sodium Hydrate According to JP Method (DS-413)
- Analysis of Alendronate Sodium Hydrate According to JP Method (2) (DS-413)
- Analysis of Alendronate Sodium Tablets According to JP Method (DS-613)
- Analysis of Alendronate Sodium Injection According to JP Method (DS-613)
- Analysis of Insulin Glargine (Genetical Recombination) and Insulin Glargine (Genetical Recombination) Injection According to JP Method (KW-802.5)
- Analysis of Trehalose According to JP Method (KS-801)
- Analysis of Insulin Human (Genetical Recombination) and Insulin Human (Genetical Recombination) Injection According to JP Method (KW-802.5)
- Analysis of Voglibose According to JP Method (NH2P-50 4E)
- Analysis of Maltose Hydrate According to JP Method (KS-801)
- Analysis of Miglitol According to JP Method (NH2P-50 4E)
- Analysis of Lactulose According to JP Method (SP0810)
- Analysis of Purified Sodium Hyaluronate Ophthalmic Solution According to JP Method (SB-802.5 HQ)
- Analysis of Insulin Aspart According to Pharmacopeia Method (KW-802.5)
- Analysis of Povidone According to Pharmacopeia Method (KC-811)
- Analysis of Mannitol According to Pharmacopeia Method (SC1011-7F)