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Certificate of Analysis
Product Name: Lambrolizumab Catalogue Number: GR-168009853
Batch Size: 100g Lot Number: 20230608
CAS Number: 1374853-91-4 Production Date:
Molecular Formula: C85H170N4OS Report Date: 2023-06-08
Molecular Weight: 1296.4 Expiry Date:
Storage: Room temperature, Protected from light and Sealed


Test Items Specifieation Results
Appearance Light brown to colorless liquid Conforms
Concentration 25.0±2.5mg/ml 26.5mg/ml
Non-reduced CE-SDS Main peak ≥ 90.0% 98.6%
SEC-HPLC Main peak ≥ 95.0% 99.2%
Isoelectric Point Corresponds to reference standard Conforms
Bacterial endotoxins ≤ 30EU/mg Conforms
Residual proteins of host cell ≤ 100ng/mg 1ng/mg
Exogenous residual DNA ≤ 100pg/mg 1pg/mg
Residual protein A ≤ 100ng/mg 1ng/mg
Biological Activity Compared with standard, the range of biological activity is from 80% to 125% 101.0%
Osmolality Corresponds to reference standard Conforms
Peptide mapping Corresponds to reference standard Conforms
N-terminal sequence Corresponds to reference standard Conforms
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Date: Date: Date:
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