According to the United States Pharmacopeia and the National Formulary, ”APPARENT WEIGHT-AVERAGE MOLECULAR WEIGHT AND POLYDISPERSITY" for GENERAL CHAPTERS "<314> MOLECULAR WEIGHT DETERMINATION FOR COPOLYMERS CONTAINING ALKYL METHACRYLATE OR ALKYL ACRYLATE" should be carried out with a column filled with L128 packing material. Use of two GPC LF-804 columns filled with L128 packing material in series confirmed the requirements were met.

System suitability requirementsCorrelation coefficient for the calibration curve** (Standard solutions): ≥ 0.99
Relative standard deviation (RSD) of determined weight-average molecular weights from 6 replicates (System suitability solution): ≤ 10%

*The version at the time of the application acquisition.
**Prepared using at least seven poly(methyl methacrylate) (PMMA) standards with peak molecular weights ranging from approximately 600 to 2,000,000 Da (g/mol).

Sample: 20 µL each
(Standard solutions) 1.0 mg/mL each of PMMA standards in eluent

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)

Sample: 20 µL
(System suitability solution) 1.0 mg/mL of PMMA (Mp 211,000) in eluent

1.