REFERENCE MATERIAL CERTIFICATE

Reference Material

This certificate is designed in accordance with ISO17034 and ISO Guide 31. This reference material (RM) was designed,produced andverified in accordance with ISO/IEC 17025, ISO 17034 and a registered qualitymanagement system ISO9001.

Uncertainty

The certified value(s) and uncertainty(ies) aredetermined in accordance with ISO 17034 with an 95% confidence level (k=2). Uncertaintyis based on the Total Combined Uncertainty, including uncertainties ofcharacterisation, homogeneity and stability testing. Stability values are basedon real evidence opposed to simulation.

The producer certifies that this reference materialmeets the specification stated in this certificate until the expiry date,provided it is stored unopened at the recommended temperature herein. Productwarranties for this reference material are set out in the terms and conditionsof purchase.

Intended Use

This RM is intended for use in a laboratory as acalibration and quality control standard or in method development foranalytical techniques.

Safety

Proper precautions should be observed whilehandling. See Safety Data Sheet.

Traceability

The balances used for gravimetric measurements arecalibrated with weights traceable to the national standards (DKD). Thecalibration of the balances is verified daily internally and annually by anexternal accredited calibration service. Chromatographic methods are traceableto the International System of Units (SI).

Homogeneity

Random replicate samples of the final packaged RMhave been analysed to prove homogeneity compliant with ISO 17034.

Storage

The RM should be stored in the original sealedcontainer at the indicated temperature.

Instructions for use

It is recommended to use 1 mg as the minimum samplesize and if less material is used, to increase the certified uncertainty by afactor of two for half sample and four for a quarter of sample. If storageafter opening is necessary, the RM should be tightly closed and kept from lightand moisture. If the RM was in a sealed ampoule, it should be transferred to avial with minimum head space.