Formulating a drug product that has to be filtered and wanted to know if there is an easier method to assess the amt of CMC-Na chromatographically.
Dear Lincoln,
Please read the following text:
Size exclusion chromatography can be used to reveal slight differences in the molecular size profiles of water soluble polymers that are within the same viscosity grade. Polymers such as carboxymethyl cellulose (CMC) may have different
physical characteristics due to the variation in the molecular weight of the material. Agilent PL aquagel-OH 40 8 µm and PL aquagel-OH 60 8 µm columns are ideal for distinguishing fine variations in CMC molecular weights, because they combine low exclusion limit, high pore volume and high column efficiency (>35,000 plates/meter) for maximum resolution. In this case, two different versions of PL aquagel-OH were
connected in series to cover a molecular weight range from 104 to 107. Column calibration was achieved using pullulan standards, also from Agilent
Columns: PL aquagel-OH 60 8 μm, 300 x 7.5 mm
(Part No. PL1149-6860)
1 x PL aquagel-OH 40 8 μm, 300 x 7.5 mm
(Part No. PL1149-6840)
Eluent: 0.5 M Na2SO4
Flow Rate: 1.0 mL/min
System: PL-GPC 50 Integrated GPC/SEC System (RI)
https://www.agilent.com/cs/library/applications/5990-7771EN_excipients.pdf
For other methods which can be utilized, please see Table 5 in the following link:
https://books.google.ps/books?id=lITLBQAAQBAJ&pg=PA355&lpg=PA355&dq=LC+method+of+analyzing+CMC-Na+in+a+formulation&source=bl&ots=97Fw-x6cFJ&sig=4dLqmt0SRYaS9Wo44xWfUzJIybA&hl=en&sa=X&redir_esc=y#v=onepage&q&f=false
Alternatively, you can use one of the methods described in the Materials and Methods section (analysis of similar compounds) of the publication contained in the following link:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4303527/
Hoping this will be helpful,
Rafik
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