EFTA00596375Set 9
2010-02-178p1,168w
Method Acceptance Criteria
Appearance ♦ Visual ♦ Clear, colorless solution with no visible particulates
Identity ♦ RP-HPLC USP ♦ Retention time (Rd of the major peak in the chromatogram of the
assay preparation ... Matter ♦ USP <788> ♦ Meets requirements for small volume injections
Limit of High Molecular ♦ RP-HPLC USP ♦ NMT.1.7%
Weight Proteins
pH ♦ USP <791> ♦ 7.0 to 7.8, determined potentiometrically
Zinc ... ug/100 USP Insulin Human Units
Assay ♦ RP-HPLC USP ♦ 3.30 to 3.64 mg/mL
Potency ♦ 95.0% to 105.0% of label claim expressed in USP Insulin Human
Units/mL
Degradation Products ♦ Report
https://www.justice.gov/epstein/files/DataSet%209/EFTA00596375.pdf