The GENERAL CHAPTERS of the United States Pharmacopeia and the National Formulary (USP-NF 2023 ISSUE 3*) includes "<314> Molecular Weight Determination for Copolymers Containing Alkyl Methacrylate or Alkyl Acrylate". The method for "apparent weight-average molecular weight and polydispersity" measurement is carried out with a column filled with L128 packing material and meets following requirement. The use of GPC LF-804 column was used in this application, using the above-mentioned method as a reference and confirmed the requirements were met.

System suitability requirement

1. (1)Correlation coefficient of the calibration curve (created using 7 or more polymethyl methacrylate (PMMA) standard samples with different molecular weights in the peak top molecular weight range of approximately 600 to 2,000,000 Da (g/mol)): ≥ 0.99
2. (2)Relative standard deviation of the weight average volume (determined from the calibration curve in six replicate analyzes using a system suitability solution (approximately 190,000 Da PMMA standard solution)): ≤ 10%.

*The version at the time of the application acquisition.

Sample: 20 μL
(Standard solution) 1.0 mg/mL each

1. 1.PMMA (Mp 965,000)
2. 2.PMMA (Mp 505,000)
3. 3.PMMA (Mp 224,000)
4. 4.PMMA (Mp 66,700)
5. 5.PMMA (Mp 20,100)
6. 6.PMMA (Mp 6,140)
7. 7.PMMA (Mp 2,870)

(System suitability solution) 1.0 mg/mL PMMA (Mp 211,000)

1.  

Currently, LF-804 is not included in L128.