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AN72914: HPAE-PAD Profiling of N-linked Oligosaccharides from Glycoproteins using Dual Eluent Generation Cartridges - Gradient for Glycans from AGP

Instrument Type: IC

Glycoprotein characterization and glycosylation profiling are important tasks in the development and production of biopharmaceutical proteins. This application note demonstrates Dual EGC capability and performance for profiling N-linked oligosaccharides released from glycoproteins using high-performance anion exchange chromatography with pulsed amperometric detection (HPAE-PAD). This record shows the separation of N-linked glycans from human acid-1 glycoprotein.

AN72914: HPAE-PAD Profiling of N-linked Oligosaccharides from Glycoproteins using Dual Eluent Generation Cartridges - Gradient for Glycans from IgG

Instrument Type: IC

Glycoprotein characterization and glycosylation profiling are important tasks in the development and production of biopharmaceutical proteins. This application note demonstrates Dual EGC capability and performance for profiling N-linked oligosaccharides released from glycoproteins using high-performance anion exchange chromatography with pulsed amperometric detection (HPAE-PAD). This record shows the separation for IgG N-linked glycans.

AB72910: Fast and Sensitive Analysis of N-Containing Bisphosphonates without Derivatization using IC-MS

Instrument Type: ICMS

Due to the very polar and strong chelating characteristics of bisphosphonates, their analysis represents a real analytical challenge. Here separation of N-containing bisphosphonates and three other bisphosphonates was achieved without derivatization. After an anion-exchange separation, the analytes were passed through an anion suppressor before detection by suppressed conductivity and single quadrupole mass spectrometry in Selected Ion Monitoring mode without the aid of a desolvation agent at any step of separation or electrospray ionization.

AN72907: Determination of Fluoride in Tooth Gel Containing Sodium Fluoride

Instrument Type: IC

Here we demonstrate that a Dionex IonPac AS15-5μm column can be used to analyze tooth gel samples for the content of fluoride. Fluoride is separated from other anions using KOH eluent generated electrolytically with a EGC III KOH cartridge and detected by suppressed conductivity. Method performance is evaluated according to the system suitability requirements described in the proposed United States Pharmacopeia (USP) monograph revision for the assay and the acceptance criterion set for sodium fluoride content in a tooth gel sample.

AN72880: Determination of Spectinomycin and Related Impurities in Spectinomycin Dihydrochloride

Instrument Type: IC

This application note demonstrates that spectinomycin dihydrochloride and related impurities can be separated with a Dionex IonPac AmG-3µm C18 column using a simple eluent method (0.1M TFA) compared to the method in the EP monograph. The separation, repeatability, and sensitivity of this method were found to meet or exceed the current EP Spectinomycin Dihydrochloride monograph performance requirements. This method is reliable and can be used for the routine monitoring of spectinomycin.

Dionex CarboPac PA1 2 mm Column Performance Test Using its QAR Method

Instrument Type: IC

Before running any samples, Thermo Scientific recommends that you first confirm the performance of the column by reproducing the lot validation report chromatogram shipped with column. Compare your results with the one reported in the quality assurance report. At least three injections should be made. This record provides an eWorkflow for executing the QAR method on an ICS-5000+ system. An ICS-6000 can be used for this application.

AU72829: HPAE-PAD Analysis of N-linked Glycans: Improving Glycan Resolution

Instrument Type: IC

This application update demonstrates improved resolution of sialylated N-glycans on Thermo Scientific™ Dionex™ CarboPac™ PA200 columns. Starting with a recently described method, changes to elution conditions were tested to improve resolution of sialylated N-glycans enzymatically released from four different glycoproteins. Separations were first evaluated on the analytical format (3 × 250 mm column). Next, the possibility that a shorter column, such as a guard column, would allow significantly improved throughput was evaluated. Finally, a narrow bore format 1 × 250 mm column was tested.

AN72792: Determination of Etimicin and Related Impurities in Etimicin Sulfate

Instrument Type: IC

This application note demonstrated that the ChP Etimicin Sulfate monograph etimicin assay method and the method for organic impurities could be successfully executed with a Dionex IonPac AmG-3µm C18 column on an ICS-5000+ system. The separation, linearity, reproducibility, and sensitivity were found to meet or exceed the current ChP Etimicin Sulfate monograph performance requirements. This method is reliable and can be used for the routine monitoring of etimicin.

AN72779: Limit of β-cyclodextrin (Betadex) in Betadex Sulfobutyl Ether Sodium

Instrument Type: IC

In this application note, we evaluated the USP monograph method. Betadex was separated on a Dionex IonPac AS11 column followed by PAD detection using the specified 3-potential waveform with a gold conventional working electrode. The method was further evaluated with the 4-potential waveform recommended for carbohydrates and a gold disposable working electrode. In this additional evaluation only the waveform was changed compared to the monograph method. Key performance parameters were evaluated including separation, system suitability, linearity, limits of detection, and precision.

AB72720: A Glycopeptide Standard for Improving Glycoprotein Hydrolysis Reaction Yield for Accurate Monosaccharide Content Determination

Instrument Type: IC

This study demonstrates use of a commercially available glycopeptide standard as a control to determine glycoprotein hydrolysis reaction efficiency. Because the monosaccharide composition of glycopeptide is known, hydrolysis efficiency under a set of conditions can be easily calculated. The monosaccharide yield for the glycopeptide was compared with that of two glycoproteins under identical conditions. This comparison revealed efficient hydrolysis using the conditions tested here. Minimally the glycopeptide standard serves as a positive control for glycoprotein monosaccharide determination.

1 mm Dionex CarboPac PA200 column Performance Test Using its QAR Method with Dual Eluent Generator Cartridge Mode

Instrument Type: IC

Before running any samples, Thermo Scientific recommends that you first confirm the performance of the column by reproducing the lot validation report chromatogram shipped with column. Compare your results with the one reported in the quality assurance report. At least three injections should be made. This record provides an eWorkflow for executing the QAR method on an ICS-6000 system using Dual EGC mode.

Dionex IonPac AS20 Column Performance Test Using its QAR Method

Instrument Type: IC

Before running any samples, Thermo Scientific recommends that you first confirm the performance of the column by reproducing the lot validation report chromatogram shipped with column. Compare your results with the one reported in the quality assurance report. This record provides an eWorkflow for executing the QAR method on an HPIC system. See column manual for detail.

AU72648: Determination of Gentamicin and Related Impurities in Gentamicin Sulfate using Simple Eluents (Part B)

Instrument Type: IC

This application update demonstrates that gentamicin sulfate and related impurities can be separated quickly compared to the method in the United States Pharmacopeia (USP) Gentamicin Sulfate monograph using a Dionex IonPac AmG-3µm C18 column with 100 mM TFA (trifluoroacetic acid) with 2% acetonitrile as the eluent . (Method B in AU 72648)). This method meets or exceeds the performance criteria for Content of Gentamicins in the USP Gentamicin Sulfate monograph.

AU72648: Determination of Gentamicin and Related Impurities in Gentamicin Sulfate using Simple Eluents (Part A)

Instrument Type: IC

This application update demonstrates that gentamicin sulfate and related impurities can be separated with a Dionex IonPac AmG-3µm C18 column using a simple eluent method (100 mM TFA (trifluoroacetic acid) and no organic solvent. (Method A in AU 72648)). This method meets or exceeds the performance criteria for Content of Gentamicins in the United States Pharmacopeia (USP) Gentamicin Sulfate monograph.

AN72647: Determination of Gentamicin and Related Impurities in Gentamicin Sulfate

Instrument Type: IC

This application note demonstrates that the USP Gentamicin Sulfate monograph Content of Gentamicins method and the USP in-process revision Gentamicin Sulfate monograph method for organic impurities method can be successfully executed with a Dionex IonPac AmG-3µm C18 column using either the 4- or 3-potential carbohydrate waveform. The separation, linearity, reproducibility, and sensitivity were found to meet or exceed the current USP/EP Gentamicin Sulfate monograph performance requirements. This method is reliable and can be used for the routine monitoring of gentamicin.

AN72680: Determination of Zinc Oxide in Sunscreen Using Ion Chromatography with Visible Absorbance Detection

Instrument Type: IC

Zinc oxide is approved by the FDA for use in sunscreens. An ion chromatography (IC) method has been proposed to replace existing titration-based assays in the monograph. The Zinc Oxide content was determined using a IC system with a cation-exchange column. The determination of zinc is achieved by the formation of anionic complexes with a eluent that contains pyridine-2,6-dicarboxylic acid (PDCA), post column derivative with 4-(2-pyridylazo)resorcinol (PAR), and absorbance detection at 530 nm. The method was validated following USP guidelines and demonstrated with different sunscreens.

AN72649: Validation of an Improved Ion Chromatography Method for the Limit of Choline Test in the USP Succinylcholine Chloride Monograph

Instrument Type: IC

Succinylcholine chloride is an approved intravenous (IV) medication used as a skeletal muscle relaxant during procedures of short duration. Choline Chloride is an impurity. An improved ion chromatography (IC) method is proposed for the limit of choline test in the USP Succinylcholine Chloride monograph. A Thermo Scientific Dionex IC system with a Thermo Scientific Dionex IonPac CS19 anion-exchange column and suppressed conductivity detection were used for the method. This application note reports the method development and evaluation.

QAR Method for the CarboPac PA20-Fast-4µm, 4x100 mm Column

Instrument Type: IC

This record describes method for reproduction of column Quality Assurance Report (QAR). Analyzing a standard sample using method conditions described in QAR is recommended in order to validate column performance prior to use. This record also includes a one-click eWorkflow for executing the QAR method on a ICS 5000+ system.

Dionex IonPac CS5A Column Performance Test Using its QAR Method

Instrument Type: IC

Before running any samples, Thermo Scientific recommends that you first confirm the performance of the column by reproducing the lot validation report chromatogram shipped with column. Compare your results with the one reported in the quality assurance report (QAR). This record provides an eWorkflow for executing the QAR method on an HPIC system. See column manual for detail. An ICS-6000 can be used for this application.

AN72580: An Improved HPAE-PAD Method for Glycoprotein Monosaccharide Determination

Instrument Type: IC

This work demonstrates an improved HPAE-PAD method using a recently introduced Thermo Scientific™ Dionex™ CarboPac™ PA20 column with 4 μm particle size to simultaneously quantify six major monosaccharides present in glycoprotein acid digests. The total run time is 20 min as compared to 32 min with the method using a 6.5 μm particle size column. The smaller particle size of this column offers higher peak efficiencies, leading to high-resolution separations and allowing a shorter column format and, ultimately, significantly shorter run times. An ICS-6000 can be used for this application.

Dionex IonPac AS12A Column Performance Test Using its QAR Method

Instrument Type: IC

Before running any samples, Thermo Scientific recommends that you first confirm the performance of the column by reproducing the lot validation report chromatogram shipped with column. Compare your results with the one reported in the quality assurance report. This record provides an eWorkflow for executing the QAR method on an HPIC system. See column manual for detail.

AN72502: Assay of Sodium Thiosulfate and Ionic Impurities in Sodium Thiosulfate Using Ion Chromatography- (Part 1-Assay)

Instrument Type: IC

Sodium thiosulfate is approved for the treatment of acute cyanide poisoning. An ion chromatography (IC) method has been proposed to replace existing titration-based assays in the Sodium Thiosulfate and its Injection monographs. Another IC method has also been proposed for determining impurities. This application note evaluates both methods following the USP guidelines (<1225>, Validation of Compendial Methods). A Dionex ICS-5000+ IC system with a IonPac AS12A column and suppressed conductivity detection were used for both method evaluations. An ICS-6000 can be used for this application.

AN72502: Assay of Sodium Thiosulfate and Ionic Impurities in Sodium Thiosulfate Using Ion Chromatography- (Part 2-Impurities)

Instrument Type: IC

Sodium thiosulfate is approved for the treatment of acute cyanide poisoning. An ion chromatography (IC) method has been proposed to replace existing titration-based assays in the Sodium Thiosulfate and its Injection monographs. Another IC method has also been proposed for determining impurities. This application note evaluates both methods following the USP guidelines (<1225>, Validation of Compendial Methods). A Dionex ICS-5000+ IC system with a Dionex IonPac AS12A column and suppressed conductivity detection were used for both method evaluations. An ICS-6000 can be used for this application.

TN72478: Instrument Configuration for Native N-linked Oligosaccharide Characterization by HPAE-PAD/MS - Gradient 3

Instrument Type: ICMS

The biopharmaceutical industry requires reliable high throughput analysis of N-linked glycans. Many of the commonly used analytical approaches are based on derivatization, which is known to introduce differential loss of sialic acid and incomplete labeling. Preparation of native glycans is not subject to these concerns. This approach starts with a fast in-solution glycoprotein digestion to obtain oligosaccharides. These native glycans are then analyzed by high-performance anion-exchange chromatography with pulsed amperometric detection coupled to MS. This record is for neutral and IgG glycans.

TN72478: Instrument Configuration for Native N-linked Oligosaccharide Characterization by HPAE-PAD/MS - Gradient 2

Instrument Type: ICMS

The biopharmaceutical industry requires reliable high throughput analysis of N-linked glycans. Many of the commonly used analytical approaches are based on derivatization, which is known to introduce differential loss of sialic acid and incomplete labeling. Preparation of native glycans is not subject to these concerns. This approach starts with a fast in-solution glycoprotein digestion to obtain oligosaccharides. These native glycans are then analyzed by high-performance anion-exchange chromatography with pulsed amperometric detection coupled to MS. This record is for charged glycans.

TN72478: Instrument Configuration for Native N-linked Oligosaccharide Characterization by HPAE-PAD/MS - Gradient 1

Instrument Type: ICMS

The biopharmaceutical industry requires reliable high throughput analysis of N-linked glycans. Many of the commonly used analytical approaches are based on derivatization, which is known to introduce differential loss of sialic acid and incomplete labeling. Preparation of native glycans is not subject to these concerns. This approach starts with a fast in-solution glycoprotein digestion to obtain oligosaccharides. These native glycans are then analyzed by high-performance anion-exchange chromatography with pulsed amperometric detection coupled to MS. This record is for IgG glycans.

TN72264: HPAE-PAD N-linked Oligosaccharide Profiling of IgG

Instrument Type: IC

This technical note reports an HPAE-PAD method to profile IgG N-linked oligosaccharides and N-linked high-mannose type oligosaccharides that are atypical for human polyclonal IgG but sometimes found on mAbs. This HPAE-PAD method is orthogonal to other oligosaccharide methods applied to IgG. More information on the development and application of the separation described in the technical note can be found in Rohrer, et al. as referenced in the document.

TN72225: Glycoprotein Monosaccharide Analysis using HPAE-PAD with Manually Prepared Eluent

Instrument Type: IC

This work describes an HPAE-PAD method for monosaccharide composition analysis using manually prepared eluent. Monosaccharide analysis using electrolytically generated eluent has been described before. Here, three commercially available proteins, IgG, fetuin, and alpha-1-acid glycoprotein, were individually subjected to two hydrolysis conditions using 1)HCl, for the amino sugars galactosamine and glucosamine, and 2)TFA, for the neutral sugars mannose, glucose, and galactose. Results for method linearity, robustness, and accuracy are presented here. An ICS-6000 can be used for this application.

AU72197 : Determination of Tobramycin Using HPAE-IPAD on a Compact IC System: 20 µM tobramycin

Instrument Type: IC

Tobramycin is an important aminoglycoside antibiotic used in ophthalmic and intravenous treatments to treat bacterial infections by blocking protein synthesis.[1] Determinations of tobramycin, kanamycin and other aminoglycoside antibiotics have been previously demonstrated by HPAE-IPAD since 2004.[2–6] This document updates Thermo Scientific™ Application Note 61 using a highpressure-capable Dionex Integrion HPIC system equipped with updated EG technology and an electrochemical detector.

AU205: Assay for Citrate and Phosphate in Pharmaceutical Formulations Using a High-Pressure Compact Ion Chromatography System

Instrument Type: IC

Using ion chromatography methods to determine citrate and phosphate in pharmaceutical formulations has been previously demonstrated, validated, and adopted by The United States Pharmacopeia (USP) in General Chapter< 345>. The monograph specified an L61 column. Here we demonstrate that a higher porosity, higher capacity, and smaller particle size L81 column with similar selectivity to L61 has much higher efficiencies, capacities, and sensitivities, and extended linear range with reduced run times.

AU206: Improved Separation of Aminobenzamide (2-AB)-Labeled N-glycans from Human α1 Acid-Glycoprotein for Analysis by HPAE-FLD

Instrument Type: IC

This application update demonstrates improved chromatographic separation achieved using a Thermo Scientific™ Dionex™ CarboPac™ PA200 column for the HPAE-FLD method described in proposed United States Pharmacopeia (USP) General Chapter <212> to separate 2-AB-labeled N-linked oligosaccharides from human α1 acid-glycoprotein. An ICS-6000 can be used for this application.

AN1148: Assay of Nitrite and Determination of Nitrate Impurity in Sodium Nitrite Using a Reagent-Free Ion Chromatography System

Instrument Type: IC

This application note reports our evaluation of the IC method for nitrite assay and nitrate determination in the proposed revision of the United States Pharmacopeia (USP) monograph for sodium nitrite using an electrolytically generated potassium carbonate/bicarbonate eluent to execute the method rather than the manually prepared sodium carbonate/sodium bicarbonate eluent described in the PF proposal.

离子色谱分离脉冲积分安培检测器测 定利培酮中的羟胺

Instrument Type: IC

利培酮(Risperidone)是比利时杨森公司1984年发 明的一种新型的苯并异嗯唑衍生物。是新一代的抗精神病药,是强有力的D2拮抗剂,可 以改善精神分裂症的阳性症状,但它引起的运动功能抑 制,以及强直性昏厥都要比经典的抗精神病药少。 羟胺用于合成利培酮原料药,羟胺对呼吸系统、皮 肤、眼部及黏膜具刺激性,吞食有害,为潜在的诱变剂, 羟胺在加热时可能发生爆炸。 目前对于羟胺的检测大多采用滴定法,分光光度法 等,实验操作复杂,灵敏度低。本实验采用离子色谱 法脉冲安培法分离测定羟胺、2-羟乙基肼、肼,分离度 好,灵敏度高,操作简便,建立了一种有效利培酮中羟 胺的方法。

达替肝素钠中硫酸根的测定

Instrument Type: IC

低分子肝素(low-molecular-weight heparin, LMWH) 是近年发展起来的新一代肝素类抗血栓药物, 其抗血栓作用优于肝素,而抗凝血作用低于肝素,且具有 皮下注射吸收良好、生物利用度高、体内半衰期长、出血 倾向小等优点,目前已广泛应用于临床。根据LMWH的来 源、生产工艺、末端结构的不同,LMWH 分为许多不同 的种类,如达替肝素钠、依诺肝素钠、那曲肝素钙、帕米 肝素钠、汀肝素钠等。达替肝素钠(Dalteparin Sodium) 是低分子肝素的一种,由亚硝酸降解肝素得到,重均分子 量5600~6400,峰位分子量6000,硫酸化程度为2.0~ 2.5/双糖单位[1]。 本实验使用高效阴离子交换色谱法测定游离硫酸根含 量,灵敏度高、选择性好、快速。

离子色谱法-紫外检测注射液中脱氧核苷酸钠

Instrument Type: IC

脱氧核苷酸钠是一种具有遗传特性的化学物质,其在 个体的生长、繁殖、遗传、变异等生理生化功能方面起着 非常重要的作用。目前常用注射用脱氧核苷酸是用脱氧核 糖核酸(DNA)为原料,经生物酶催化水解反应生成脱 氧腺苷酸(dAMP),脱氧鸟苷酸(dGMP)、脱氧胞苷 酸(dCMP)和脱氧胸苷酸(TMP)等四种脱氧核苷酸, 然后经层析分离获得高纯度四种单一脱氧核苷酸产品。医 药常使用复方制剂,组分包含脱氧糖胞嘧啶核苷酸、脱氧 核糖腺嘌呤核苷酸、脱氧核糖胸腺嘧啶核苷酸及脱氧核糖 鸟嘌呤核苷酸钠盐。用于急、慢性肝炎,白细胞减少症, 血小板减少症及再生障碍性贫血等的辅助治疗。 对于脱氧核苷酸的检测,现有药典方法推荐使用 Whatmen Partisil-5 SAX色谱柱分离[1],分离效果较差,且 硅胶基离子交换柱使用寿命短。本文则着重研究了高分子 聚合物机制的DNAPac 系列阴离子交换色谱柱用于脱氧核 苷酸的分离[2],并将之应用于多种不同品质的注射用脱氧 核苷酸钠制品的测试。

羧甲司坦中氯乙酸的测定

Instrument Type: IC

羧甲司坦 [ S-(羧甲基)-半胱氨酸 ] 是黏痰溶解药,能减 少支气管的粘液分泌,使痰的粘稠度下降而易于咳出[1]。临 床上用于慢性支气管炎,支气管哮喘等引起的痰液稠厚、 咳痰困难、肺通气功能不全。羧甲司坦是由L-半胱氨酸和 氯乙酸在氢氧化钠催化下缩合而成,目前的生产工艺不可 避免含有少量氯乙酸残留。氯乙酸有毒,半致死剂量为 76 mg/kg。有心脏毒性和血液毒性,还有可能致癌,因 此必须严格控制其含量。2010版中国药典标准提高项目 中,对羧甲司坦的氯乙酸含量提出了检测要求[2]。 羧甲司坦及其杂质的检验方法为液相色谱法,但无法 检测低含量的氯乙酸。氯乙酸的检测方法有气相色谱法和 离子色谱法。但气相色谱法需要衍生,操作麻烦。离子色 谱法则直接进样就可以达到比较高的灵敏度,因此选用离 子色谱法进行检测。

抑制型电导-离子色谱法测定左乙拉西坦中 的四丁基铵

Instrument Type: IC

文中建立了一套测定左乙拉西坦原料药中四丁基胺 的离子色谱方法,样品中基体不影响待测物质的准确分 析。待测物四丁基胺在SCS1上的峰形很对称,方法分析 速度快,操作简便,灵敏度等均可完全满足此类样品测 定的要求。

离子对色谱-脉冲安培检测小诺霉素等 氨基糖苷类抗生素

Instrument Type: IC

硫酸小诺霉素属氨基糖苷类抗生素,是中国自主研发的抗生素新药,被 中国药典2010版收载,药典所用分析方法为液相分离——蒸发光检测器检 测。但是蒸发光散射检测器在灵敏度和定量方面存在不足,我们开发了离子 对色谱分离-柱后衍生-安培检测的方法,以提高杂质的检出程度,并制定新 的定量方法。 目前欧洲药典测定庆大霉素等氨基糖苷类抗生素采用的也是离子对色谱 分离柱后加碱衍生-安培检测方法,在该方法条件下,庆大霉素的有关物质 和四种主要组分的分离度良好,检测的灵敏度大大提高。本文研究比对了检 测小诺霉素的离子对色谱条件和检测模式,进一步优化分离和衍生的色谱条 件,从分离度和灵敏度两个方面的数据来看,离子对色谱分离-柱后加碱-安 培检测方法都显示了优越性且淋洗液中盐的浓度很高,适合用全peek材料的 离子色谱来分析。

毛细管型离子色谱-脉冲安培检测枸杞多糖的单糖组成

Instrument Type: IC

本文使用毛细管离子色谱-安培检测研究了枸杞多糖 的单糖组成,对其中几种低含量单糖的浓度也可进行准 确测定。对水解使用酸种类和浓度、水解温度和时间等 前处理条件进行了考察优化,并结合离子色谱糖分析柱 对单糖的良好分离能力和脉冲安培检测的高灵敏度,可 以对枸杞多糖中单糖组分进行更全面的剖析。本文采用 的测定方法也可以广泛用于其他物质中多糖的检测,为 多糖结构研究提供更全面有效的信息。

电导检测器检测达肝素钠中亚硝酸根

Instrument Type: IC

达肝素钠的生产过程中使用了亚硝酸,而亚硝酸根是一种毒性物质,在 人体特定的环境条件下,可以合成一种很强的化学致癌物——N-亚硝基化合 物,能够诱发几乎所有内脏器官的肿瘤。因此,检测达肝素钠中残留的亚硝 酸根含量,对保证患者用药安全具有重要意义。目前欧洲药典使用离子色谱- 安培检测法测定达肝素钠中亚硝酸根含量[2],国内低分子肝素标准中使用化学 方法对亚硝酸根进行限度检查,无含量测定[3]。欧洲药典的方法未对样品进行 前处理,达肝素钠保留在色谱柱上,缩短柱寿命,且重现性较差。本文建立 了离子色谱法分离、电导检测器检测达肝素钠中的亚硝酸根含量的方法,灵 敏度高,线性、回收率、重现性好,可以延长色谱柱寿命。

离子色谱法测定帕米膦酸二钠注射液 的含量

Instrument Type: IC

本文所建立的离子色谱法测定帕米膦酸二钠注射液 的含量的方法,准确、灵敏、简便,可用于帕米膦酸二 钠注射液的质量控制,并为帕米膦酸二钠其他制剂的含 量测定提供了参考。

离子色谱法测定氯膦酸二钠及其制剂 的含量和有关物质

Instrument Type: IC

离子色谱法在检测离子型或可离子化药物方面具有很 大的优势。氯膦酸二钠在水溶液中呈弱酸性,在碱性介质 中可转变成为阴离子,因此可以用离子色谱法测定其含 量及有关物质。本研究应用抑制电导型离子色谱法同时测 定氯膦酸二钠及其制剂的有关物质和含量,方法准确、灵 敏、专属、快速,避免了复杂的样品预处理和衍生化过 程,同时测定多种组分,能更好地控制氯膦酸二钠及其制 剂的产品质量。

离子色谱-脉冲安培检测磺丁基醚-β-环糊精中的β-环糊精

Instrument Type: IC

SBE-β-CD样品基体相对简单,干扰较少,易于分 离。安培检测器可进一步提高方法的选择性。方法前处 理简单,样品水稀释后即可直接进样分析,样品谱图见图 1。方法线性良好,灵敏度高,重现性好。

Determination of Sulfate and Sulfamate in Topiramate Using a Compact Reagent-Free Ion Chromatography System

Instrument Type: IC

Determination of sulfamate and sulfate are used to monitor and confirm topiramate degradation. In application note 238 we demonstrate the use of a Reagent-Free Ion Chromatography (IC) system with a Thermo Scientific Dionex IonPac AS11 column and suppressed conductivity detection for the determination of sulfamate and sulfate in topiramate. This record shows that the method can be run using a new compact IC system: the Thermo Scientific Dionex Integrion system.

Assay for Citrate and Phosphate in Pharmaceutical Formulations Using a Compact IC System

Instrument Type: IC

Citric acid is a common ingredient found in pharmaceutical formulations. An assay for citrate and phosphate in pharmaceutical formulations using ion chromatography with a Thermo Scientific Dionex IonPac AS11 hydroxide-selective, anion-exchange column and suppressed conductivity detection was validated in Application Note 164. The method incorporates an electrolytic eluent generator to automatically produce an isocratic potassium hydroxide eluent. This record shows that the method can be run using the Thermo Scientific Dionex Integrion system.

IC Assay for Lithium, Sodium, and Calcium in Lithium Carbonate Using a Compact Ion Chromatography System

Instrument Type: IC

Lithium carbonate is used to treat a number of mental health problems associated with chemical imbalance in the brain. Sodium and calcium are possible cationic impurities in lithium carbonate preparations. This record shows a method that uses a Thermo Scientific Dionex IonPac CS16 cation-exchange column, an electrolytically generated MSA eluent, and suppressed conductivity detection to determine lithium, sodium, and calcium in lithium carbonate that was published in Application Note 1090. In this record the method is executed using an Integrion ion chromatography system.

Determination of Ammonia in Sodium Bicarbonate Using a Compact Ion Chromatography System

Instrument Type: IC

One of the main pharmaceutical uses of sodium bicarbonate is for hemodialysis. For hemodialysis-grade sodium bicarbonate, the quality and purity requirements are stringent. Ammonia is one of the impurities that is assayed in sodium bicarbonate because the presence of elevated levels of ammonia in the blood stream can have adverse effects. This record describes an ion chromatography (IC)-based method for the determination of ammonia (as ammonium) in sodium bicarbonate that was published in Application Note 1073. In this record the method was executed using an Integrion IC system.

Determination of Galactosamine Containing Organic Impurities in Heparin Using a Compact Ion Chromatography System

Instrument Type: IC

This record shows that AN233 can be run using an Integrion ion chromatography system. In AN233, the organic impurities in heparin are determined by HPAE-PAD using the Dionex CarboPac PA20 column following the USP monograph method. This method provides sensitive determination of galactosamine in acid-hydrolyzed heparin samples, enabling the identification of heparin that has been contaminated with chondroitin sulfates.

Determination of Glucosamine in Dietary Supplements Using a Compact Ion Chromatography System

Instrument Type: IC

This record shows the rapid, rugged HPAE-PAD method for determining glucosamine in dietary supplement tablets, gelatin capsules, and fortified liquids that was published in Application Note 197. In this record the method is executed on an Integrion ion chromatography system.

Determination of L-Fucose, D-Galactosamine, D-Glucosamine, D-Galactose, D-Glucose and D-Mannose Using the CarboPac PA20 Column QAR Method

Instrument Type: IC

A simple HPAE-PAD method for the direct determination of monosaccharides by Reagent Free ICS 5000+ system, requiring only deionized water to electrolytically produce a KOH eluent. The method in this record is the Quality Assurance Report (QAR) method, and therefore can be used to test the performance of a Thermo Scientific Dionex CarboPac PA20 column. An ICS-6000 can be used for this application.