供应美国NIST临床检验材料冷冻甘氨酸标准溶液SRM 3655
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Purpose: This Standard Reference Material (SRM) is intended primarily for use as a calibration standard for the measurement of enzymatically released N-linked glycans. Potential applications of SRM 3655 include the benchmarking and comparability of analytical techniques, as a material for ensuring system suitability, and for analytical method validation. This material may also be used to value-assign in-house calibrators or control materials.
Description: A unit of SRM 3655 consists of thirteen (13) aqueous solutions of glycans commonly associated with monoclonal antibody therapeutics. Each solution contains a purified free-reducing glycan at a known mass fraction. 美国NIST临床检验材料
A unit of SRM 3655 consists of thirteen 0.5 mL vials each containing approximately 0.2 mL of solution, frozen.Certified Values: The certified mass fractions and estimated uncertainties for the 13 glycans provided in Table 1 are based on the results obtained from the gravimetric preparation of the solutions along with a comprehensive purity analysis, and from the analytical results determined using liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis. A NIST certified value is a value for which NIST has the highest confidence in its accuracy in that all known or suspected sources of bias have been investigated or taken into account [1]. Values are provided in mass fraction units (micrograms per gram), and for user convenience, in amount-of-substance concentrations (micromoles per liter). The amount-of-substance concentrations were calculated from the mass fraction values using the density of water at 22 °C (0.9977 g/mL ± 0.00083 g/mL) [2] and the average, relative molecular masses and uncertainties [3] of each glycan.
The measurand is the total mass fraction of glycan. Metrological traceability is to the International System of Units (SI) derived units for mass (expressed as micrograms per gram). The uncertainties provided with the measured glycan certified mass fraction values are expanded uncertainty about the mean to cover the measurand with approximately 95 % confidence, consistent with the ISO/JCGM Guide [4]. The expanded uncertainty is calculated as U = kuc, where uc is the combined uncertainty, and k is a coverage factor corresponding to approximately 95 % confidence for the analyte [5]. For the certified values shown below, k = 2.
目的：本标准参考物质（SRM）主要用作测量酶促释放的N-连接聚糖的校准标准。SRM 3655的潜在应用包括分析技术的基准测试和可比性，作为确保系统适用性和分析方法验证的材料。该材料也可用于内部校准器或控制材料的赋值。 冷冻甘氨酸标准溶液SRM 3655
描述：SRM 3655的一个单元由十三（13）种聚糖水溶液组成，这些聚糖通常与单克隆抗体治疗剂有关。每种溶液都含有一种已知质量分数的纯化的游离还原聚糖。
SRM 3655的一个单元由13个0.5 mL小瓶组成，每个小瓶含有约0.2 mL冷冻溶液。认证值：表1中提供的13种聚糖的认证质量分数和估计不确定度基于溶液重量制备的结果以及综合纯度分析，以及根据使用液相色谱-串联质谱（LC-MS/MS）分析确定的分析结果。NIST认证值是指NIST对其准确性具有最高信心的值，因为所有已知或怀疑的偏差源都已被调查或考虑[1]。数值以质量分数单位（微克/克）提供，为了用户方便，以物质浓度的量（微摩尔/升）提供。使用22°C下的水密度（0.9977 g/mL±0.00083 g/mL）[2]和每个聚糖的平均值、相对分子质量和不确定度[3]，根据质量分数值计算物质浓度。
被测物是聚糖的总质量分数。计量可追溯性是指国际单位制（SI）衍生的质量单位（以微克/克表示）。根据ISO/JCGM指南[4]，测得的聚糖认证质量分数值提供的不确定度是关于平均值的扩展不确定度，以大约95%的置信度覆盖被测物。扩展不确定度计算为U=kuc，其中uc是组合不确定度，k是对应于分析物约95%置信度的覆盖因子[5]。对于以下所示的认证值，k=2。