Mycotoxin Reference Materials for Accurate and Reliable Analysis Results

Romer Labs offers the broadest range of mycotoxin reference materials currently available globally under the brand name Biopure. High quality calibrants are a must for accurate and reliable results in any analysis.

Biopure™ calibrants

Biopure™ calibrants are high quality mycotoxin reference materials characterized by appropriate independent methods, like HPLC, NMR and LC-MS/MS. This ensures the identity and purity of the reference materials.

Mycotoxin reference materials are accompanied by certificates, created in accordance to ISO Guide 31. This includes stating the uncertainty of the target analyte and documenting the traceability of the certified value.

Biopure™ calibrants are available in liquid “ready-to-use” and crystalline forms, and as single calibrants as well as calibrant mixtures. Customized calibrants are available upon request.

To fulfill even the most stringent criteria that ISO 17025-accredited labs require from reference materials, Romer Labs offers high quality calibrants produced under the ISO 17034 accreditation.  BiopureTM ISO 17034 (certified) reference materials are defined as reference materials characterized by metrological traceability, homogeneity data, long- and short-term stability data and a certified value including uncertainty. ISO 17034 (certified) reference materials are aligned with all relevant requirements of ISO 17025 and come with a CoA according to the ISO 17034 standard.

The stars of the Biopure™ product line are the fully labeled 13C internal standards for mass spectrometry analysis. These unique calibrants are available for all regulated mycotoxins and rely on a patented technology, proprietary to Romer Labs. 

Biopure TM Product List

 

Biopure™ quality control materials

Quality control materials (QCM) are intended for method validation purposes and for the control of the performance of an analytical method.

Romer Labs offers a range of QCM for most of the regulated mycotoxins in different contamination levels and matrices. Readily available are QCM for Deoxynivalenol, Fumonisins, Ochratoxin A and Zearalenone as well as multitoxin and blank materials.

These materials represent naturally contaminated materials with a Romer Labs in-house characterization using an ISO 17025 accredited LC-MS/MS method. Certificates of analysis are provided with each batch.

Biopure TM Product List

Equipment


Additional Equipment

Romer Labs also offers additional equipment. For some analyzes (eg. aflatoxins) by HPLC-FLD, a derivatization of the analytes is necessary. Romer Labs provides equipment like the Romer Derivatization Unit (RDU, photochemical) and the Romer Cell (electrochemical) for post-column derivatization.

Romer Labs Evap System can be used for rapid evaporation of common organic solvents.

Item No. Description
Romer® Cell
10002778 Romer® Cell
Item No. Description
Romer Evap® System
10002546 12 Port, small, 115V
10002549 12 Port, large, 115V
10002550 24 Port, small, 115V
10002553 24 Port, large, 115V
10002547 12 Port, small, 230V
10002548 12 Port, large, 230V
10002551 24 Port, small, 230V
10002552 24 Port, large, 230V

Complaint Management

There is a well-established and documented procedure for handling complaints and work that do not conform to the applicable norm within Romer Labs. A database is used to document all complaints (deriving both from internal and external sources). There, the responsibilities for root cause analyses and corrective or preventive measures are also defined and the communication process to the customer is clearly established. Among other things, the complaint procedure – in the context of our program for addressing risks and opportunities – serves as a starting point for the continual improvement of our products, processes and service.

Procedure

 

 

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