Contract Analysis based on Regulations & Standards
Sevaral guidelines, regulations and standards are provided for reliable analysis of macromolecules. PSS provides contract analysis based on these national and international standards.
REACH Polymer Status
Under the registration, evaluation and authorization of chemicals (REACH) Regulations (EG) no. 1907/2006 the producer, manufacturer or importer of chemical substances/formulations have to register their products (> 1 ton/year) at the chemical agency. In the context of REACH, Polymers are substances, defined under article 3, No.5, as "special" substances, based on their composition and structure. The preferred method to identify whether a substance falls under the definition of a polymer is GPC/SEC.
PSS provides GPC/SEC in a variety of solvents at temperatures up to 155 °C. The analysis fee for the first sample includes calibration, validation and verification of the system according to the PSS quality conditions. For room temperature applications additional ESI-MS detection can be applied (PSS P/N 831-1001).
On request PSS provides also the peak area calculation required by REACH (Peak Area Calculation (REACH) and specific reporting (REACH discussion).
PSS provides characterization data for regulatory submissions, stability or product release testing. Calculation of the percentage of a given molar mass (eg. < 500 g/mol) from the molecular weight distribution is usually requested for product approval in many countries. Additives and stabilizers can be separated from the polymer and a quantitative determination of these compounds is possible. The analysis report lists all relevant parameters of the measurement and documents the sample preparation.
PSS uses GPC/SEC in a variety of solvents at temperatures up to 155 °C to investigate the samples. Slice lists are available on request.
The demand for the analysis of raw materials according to pharmacopeia methods has increased dramatically. Analysis according to pharmacopeia methods is a complex operation requiring access to a variety of equipment.
PSS performs GPC/SEC pharmacopeia methods according to the European Pharmacopoeia (EP), the United States Pharmacopeia (USP), the British Pharmacopoeia (BP), the Japanese Pharmacopoeia (JP) and others. PSS also utilizes customer specified and proprietary methods.
Examples for EP/USP analysis amongst many others are:
- Glycerol Testing
- Gelatin Testing
- Heparin/Enoxaparin Sodium Testing
- Chondroitin Sulfate Testing
- HES Testing
- Insulin Testing
- Dextran Testing
PSS provides ASTM, ISO and EN standard tests for the characterization of plastics and polymers.
A short list of typical applications we regularly work with includes
- ASTM D3418 / E1356
- ASTM E1131
- ASTM D2238 -92 (2004)
- ASTM D4001 - 93 (2006)
- ASTM D5227 -01 (2008)e1
- ASTM D5296 -05
- ASTM D5591 -98 (2004)
- ASTM D6042 -09
- ASTM D6953 -03
- ASTM D7210 -06
- DIN EN ISO 4288
- DIN 53122-2
- ISO 11357
- Migration test EC 282-2008