Pribolab - MSS1083-5Pribolab®毒黄素-55280

1.  General information

This document is designed and the certified value(s) and uncertainty(ies) are determined in accordance with ISO Guide 31^[1]and Eurachem / CITAC Guides ^[2,3].

2.1 Intended use of the RM

- for laboratory use only

- calibration of analytical instruments

2.2  Instruction for the correct use of the RM

The compound should be stored at -20℃ in a dark place. Before usage of the RM , the compound should be allowed to warm to temperature(20±3℃).The recommended minimum sub-sample amount for all kinds of application is 1mg. Certified values and uncertainties can only be guaranteed if the minimum sampling volume requirement is met.The expiry date of this RM is based on the current knowledge and holds only for proper storage conditions in the originally closed flasks/ packages.

2.3  Hazardous situation

The normal laboratory safety precautions should be observed when working with this RM.Further details for the handing of this RM are available as safety data sheet.

5. Certified values and their uncertainties

Toxoflavin
Compound	Purity
Toxoflavin	Certified value	Uncertainty
	98.8%	±1.2%
The certified value is based upon the results from several analytical techniques Expanded uncertainty U (k = 2) of the value uc according to GUM [4]

4.  Discussion of traceability

The qualitative analysis for principal component of the material is obtained by liquid chromatography-mass spectrometry (LC-MS), ultraviolet and visible spectroscopy (UV-VIS) and nuclear magnetic resonance (NMR). The certified value (purity of Toxoflavin) is based on the results of mass balance method and qNMR method. Structure related impurities are determined by liquid chromatography - tandem mass spectrometry (LC-MS/MS). Moisture content, inorganic impurities and volatile organic compounds are measured by Karl Fischer, ICP-MS and GC-FID respectively. Based on the above results, the purity certification value is given.

All weighting and dilution steps for preparation were done using calibrated equipment (microbalances, pipettes). The gravimetric preparation furthermore was performed in a standardized and certified class A flask with stated uncertainty as well as using traceable thermometers for temperature controlled preparation. The whole preparation process is therefore traceable to SI units and metrological traceability is given.

5.  Purity assessment of Toxoflavin

5.1 LC-MS/MS

The purity check using gradient LC-MS/MS of the Toxoflavin sample showed one main peak after blank subtraction.

5.2 HPLC-DAD/FLD

The purity check using LC-DAD of the Toxoflavin sample showed one main peak after blank subtraction. The peak purity of the main signal was examined by diode array spectra of the Toxoflavin peak and led to the conclusion that this peak consists only of Toxoflavin. The purity check using LC-FLD of the Toxoflavin sample showed one main peak .

6.  Further information

The purchaser must determine the suitability of this product for its particular use. Pribolab makes no warranty of any kind, express or implied, other than its products meet all quality control standards set by Pribolab. We do not guarantee that the product can be used for a special application.

Inspected by：

Quality System Specialist