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Quality Definitions and Grades
Sigma-Aldrich Buchs Integrated Management System, IMS
Quality Management is part of IMS and based on the ISO standard 9001/2000. The documentation also covers our GMP operations, safety and environmental concerns.
Sigma-Aldrich Buchs Authorization for GMP and cGMP
Qualified employees and equipment allow customer synthesis under GMP and cGMP conditions. Due to this high quality standards Sigma-Aldrich Buchs is authorized to produce active pharmaceutical ingredients.
Sigma-Aldrich Seelze Integrated Management System, IMS
The Seelze site has been certified to DIN EN ISO 9001 since 1992. In 1999 DIN EN ISO14001 was integrated and the quality management system refocused on the process.
Product Qualities
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In addition to the explicit product specification which refers to product appearance, composition, activity, purity, impurities, suitability for application, special standards (e.g. ACS) and physical values Fluka products are comprehensively described by their purity grades and special qualities. Certain products are also supplied in compliance with official monographs.
Please click below for different product qualities.
Common Purity Grades
Application-Oriented Specifications
Qualities to Official Monographs
Common Purity Grades
All Fluka and Riedel-de Haën products have been classified in a single, consistent system of 3 purity grades:
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These categories are often supplemented by:
- application-specific designations such as p.a., BioUltra, etc.
- official designations such as ACS, DIN, etc.
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Table 1: Definition of the common Purity Grades
Definition of further Indications in the Specification Text
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| ~ |
where a numerical value is indicated in this way, fluctuations are possible. The tolerated fluctuation range can be consulted for each specific product |
| colourless |
<25 Hazen (APHA), for liquids and solutions |
| clear |
<3.5 TE (F) (NTU), for liquids and solutions |
| Percentage indicated for chromatographic methods: percent by area (unless otherwise stated). |
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Application-Oriented Specifications
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- BioUltra
This quality designation documents the suitability of a product for use in biochemistry. Properties relevant to biochemistry such as enzyme activities, absence of heavy metals or enzyme traces, protein content, etc. are explicitly specified for this purpose. Many BioChemika biochemicals are described as being suitable for a particular application by the use of additional words such as for gel electrophoresis or for molecular biology.
- BioUltra
Product supplied under this quality designation meet the highest requirements:
- homogeneous appearance without discoloration
- clear solution in the solubility test
- no residue in the filter test (Millipore® 0.45 mm membrane filter)
- defined maximum value for UV absorption at biochemically relevant wavelengths
- defined pH in aqueous solution.
BioUltra products are handled and packaged in a dust- and humidity-controlled atmosphere.
- BioUltra for Molecular Biology
These products are additionally tested for applications in molecular biology and hence for the absence of the following enzyme traces:
- DNAses, RNAses
- proteases
- phosphatases.
- p.a. (pro analysi)
Products with a guarantee certificate and/or suitable for the stated analytical application.
- p.a. plus
Analysis reagents that satisfy still higher requirements in the trace area such as absence of mercury and arsenic.
- SelectophoreTM
- Products for sensor application, special ion-selective molecules and aids for electrode production. All SelectophoreTM products satisfy the relevant application test requirements.
- TraceSelect
Products for trace analysis. Metal traces in the ppb range are specified.
- TraceSelect Ultra
Products for ultra trace analysis. The specifications for metal traces are one to two powers of 10 lower than TraceSelect.
- Certified Reference Materials
Materials tested by two independent institutes and suitable for use as primary or secondary reference standards. These products are delivered with detailed certificate.
- ChiraSelect
Reagents for derivatization of chiral molecules. The guaranteed enantiomer purity is >99.5 : 0.5%.
- Standard Fluka
Products, mainly stains for microscopy, which meet the Fluka quality standard.
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Qualities to Official Monographs
- Pharmacopoeia
Products which are specified in a pharmacopoeia, e.g. Ph. Eur., satisfy all the requirements of the relevant monograph, including the current provisions concerning solvent residues. This means that, unlike all other Fluka products, these products can be used for official applications.
- ACS
These products satisfy the specifications of the American Chemical Society
- Supplier's Own Specifications
Fluka also supplies small volumes and samples for some major chemical manufacturers. A brand name refers to the relevant specification of the original manufacturer, e.g. Wacker quality.
- Customer-Specific Specifications
The relevant specifications of customer synthesis and OEM products are discussed individually with the customer or even developed with the customer. This information is treated as strictly confidential.
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Special Qualities
- Pharmacopoeia Qualities
More than 200 products meet the analytical specification of a Pharmacopoeia, as the limits specified in the particular monograph are also applicable to our products. In addition, the residual solvents parameter is verified for these substances.
- Chromatography Qualities
The brand names CHROMASOLV® and PESTANAL® are synonymous with quality in HPLC and GC applications. Typical test parameters include for example UV transmittance in the case of CHROMASOLV® and suitability for residue analysis in the case of PESTANAL®.
- Spectroscopy Qualities
The brand name SPECTRANAL® advertises a specific quality test for use in UV/IR and NMR spectroscopy. Typical test parameters include for example suitability for IR and suitability for NMR.
- Semiconductor Grade Qualities
Products for the electronics industry. Particles and metal traces are specified. The quality gradations are:
MOS/VLSI/ULSI/SLSI
The particle and metal trace contents of the reagents decrease in the direction from MOS to SLSI.
- Karl Fischer Qualities
Reagents of the HYDRANAL® product range are tested with regard to the special requirements of Karl Fischer titration, for example a particularly low water content.
- Customer-Specific Specifications
Special product specifications can be tailored to a customer's unique requirements. These agreements are kept confidential.
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