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GPCSEC METHOD DEVELOPMENTS & VALIDATIONS
GPC/SEC Method Developments
Many organizations and institutions involved in developing new synthetic polymers/copolymers or new applications for existing synthetic polymers, natural polymers, and biopolymers often face challenges when characterizing their material or product.
Examples of challenges include:
- polymer solubility
- ionic charge
- complex polymer chain microstructure
- very high molecular weight
- broad molecular weight distribution
- polymer aggregation
- polymer degradation, shelf-life, and stability
- oligomeric composition
- copolymer composition
- complex multi-component composition of final product
- unknown concentration of the target polymer
- interference of other components with the target polymer etc.
PolyAnalytik addresses the unique challenges of specific applications to develop comprehensive and reliable GPC/SEC analytical methods to measure molecular properties of newly emerging or existing applications and polymers. Methods developed for a customer are transferable to their laboratory including GPC/SEC columns, standards, and comprehensive training of analytical staff.
Our team of experts communicates with customers to obtain necessary information including sample concentration, composition, chemistry, synthetic process, manufacturing process, and applications to define project objectives. A detailed work plan is formulated with clear objectives, estimated time and cost for each section of the project.
The work plan typically includes sample description and evaluation (e.g. solubility testing and chemical analysis), sample preparation (e.g. proposed extraction/purification procedures), GPC method
development which includes determining optimal GPC conditions (e.g. mobile phase, flow rate, temperature, GPC columns, standards), and development of GPC analysis procedure for measurement of target molecular parameters (e.g. molecular weight, molecular weight distribution, intrinsic viscosity, chain conformation, copolymer composition, branching analysis, weight fraction analysis, concentration, etc.).
Many development projects include the development of extraction procedures for complex multi-component samples to analyze the targeted polymer. We have a broad range of experience dealing with
synthetic polymers and copolymer, polymer-conjugated proteins, environmental samples, food formulations, biological samples, etc. For specific examples, please visit our library of Application Notes.
The cost of method development projects vary depending on the complexity and scale of the samples/applications.
GPC/SEC Method Validations
All SEC/GPC analytical methods possess a certain degree of variation which can be nfluenced by various factors including: instrumentation (e.g. make and model of analytical instrument, specifications of different detectors), specifications of GPC column sets (e.g. dimensions, stationary phase, particle size, pore size, exclusion limit, and theoretical plate number), calibration and verification standards (NIST traceability or Pharmacopeia certification), standards and samples preparation (e.g. concentration, dissolution solvent composition, reagent grades, dissolution temperature and time, filtration), GPC conditions (e.g. mobile phase composition, reagent grades, flow rate, temperature), and analyst.
PolyAnalytik offers method validations to determine the accuracy, reproducibility, and degree of variation for molecular parameters measured using a wide range of GPC methods in different mobile phases including aqueous buffers and organic solvent/mixtures and system configurations include different type of detector used (e.g. refractive index, UV, light scattering, and viscometer).
The reproducibility and degree of variance attributed to the GPC method is examined for
targeted molecular parameters such as molecular weight (MW), molecular weight distribution (polydispersity index, PDI), intrinsic viscosity, concentration, Mark-Houwink parameters (alpha, log K), and Weight Fractions of oligomers. The lowest detectable limit of the different detectors used in the GPC method is also often assessed as part of the validation study. This is of particular interest for projects requiring accurate quantification/concentration measurements of a polymer in very dilute solutions.
