Pribolab - MAS-M301-0.5Pribolab®河豚毒素 、4-EPI-河豚毒素、4,9-脱水-河豚毒素混合溶液/（浓度以批次为准）-60916

1. General information

This document is designed and the certified value(s) and uncertainty(ies) are determined in accordance with ISO Guide 31^[1].

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℃ or below 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 100 μL. 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

If sufficient quantities are ingested ,Tetrodotoxin 、4-epi Tetrodotoxin、 4,9-anhydro Tetrodotoxin can cause paralysis and even death^[2]. Only qualified personnel should handle the solution and appropriate disposal methods should be used. Heavy gloves and eye protection should be used when opening the ampoule in the event the glass shatters.

3. Certified values and their uncertainties

3.1 Calculation of uncertainty

After the concentration of the gravimetric prepared solution was confirmed by HPLC-FLD,the uncertainty of the calibrant was calculated on the basis of preparation^[4].

a   Maximum tolerance of purity was divided by

b Calculation of this u-value is based upon the uncertainty formula for the weighed amount as given in the calibration report from annual balance calibration

c  A triangular distribution(division by )was chosen for the calculation of u(cal)

d  Based on a series of ten fill and weigh experiments on a typical 200mL flask; the value was used directly as a standard deviation  

e  Based on the density of 0.9982g/cm³ at temperature T=20℃ and a maximum  temperature variation of ±3℃,of volume expansion, relative volume expansion  coefficient of acetonitrile is 1880*10^-6/℃[5],volume expansion term(rectangular distribution)was divided by

f   The three contributions are combined to give the u(V)=

Calculation of the combined uncertainty u _c and the expanded standard uncertainty U

4.Discussion of traceability

This calibrant is certified on the basis of gravimetric preparation[^4]. Thus the certified value mass concentration of Tetrodotoxin 、4-epi Tetrodotoxin、 4,9-anhydro Tetrodotoxin is based on the weighed amount of the starting material and is therefore traceable to the stated purity of the solid raw material. High purity material represents a practical realization of concentration units, through conversion of mass to molar quantity.

5. Confirmation of certified value by HPLC-FLD

The certified concentration of Tetrodotoxin 、4-epi Tetrodotoxin、 4,9-anhydro Tetrodotoxin of the gravimetric prepared solution was confirmed by HPLC-FLD against an independently prepared reference batch of Tetrodotoxin 、4-epi Tetrodotoxin、 4,9-anhydro Tetrodotoxin.

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