NIST- SRM 3655 Glycans in Solution(Frozen)

NIST- SRM 3655  Glycans in Solution(Frozen)


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. NIST- SRM 3655

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. Glycans in Solution(Frozen)

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.


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