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Standardization and validation of molecular size distribution test for human immunoglobulin products in Korea

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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

e

Human normal immunoglobulin in glycine

≥ 90 Not specified ≤ 3 Not specified

f

Human 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

Specification of peak area of polymers/aggregates of Human normal immunoglobulin in glycine is not

specified in the KMRBP, but the specification was approved not more than 3 %.

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