1
Supplementary Table 1. Specification for molecular size distribution of seven types of human immunoglobulin products.
Type of product Peak area of monomer/dimer (%) Peak area of polymers/aggregates (%)
Ph. Eur. KMRBP Ph. Eur. KMRBP
eHuman normal immunoglobulin in glycine
≥ 90 Not specified ≤ 3 Not specified
fHuman normal immunoglobulin in maltose
≥ 90 Not specified ≤ 3 ≤ 1
Human hepatitis B immunoglobulin for intravenous administration
≥ 90 Not specified ≤ 3 ≤ 1
Human normal immunoglobulin
≥ 85 Not specified ≤ 10 ≤ 10
Human tetanus immunoglobulin
≥ 85 Not specified ≤ 10 ≤ 10
Human hepatitis B immunoglobulin
≥ 85 Not specified ≤ 10 ≤ 10
Human varicella immunoglobulin
≥ 85 Not specified ≤ 10 ≤ 10
e
Specification of peak area of polymers/aggregates of the current KMRBP includes peak area of fragments. In the present study, the results of peak area of fragments were not more than 0.103 %, so it did not affect the judgement of acceptability of specification (data not shown).
f