Description
Technical Parameters
Product Brief Introduction
Product name: Insulin Glargine
CAS: 160337-95-1
MF: C22H27N3O2
MW: 365.469
Product Specification
|
Item |
Specification |
|
Appearance |
White or off-white powder |
|
Identification |
Retention time of the major peak consistent with reference standard |
|
Peptide mapping consistent with reference standard |
|
|
Loss on Drying |
≤ 8.0% |
|
Sulfated Ash |
≤ 2.0% |
|
Related Substances |
Zinc ≤ 0.8% (on dried basis) |
|
High molecular weight proteins ≤ 0.3% |
|
|
Maximum single impurity ≤ 0.4% |
|
|
Total impurities ≤ 1.0% |
|
|
Bacterial Endotoxins |
< 10 EU/mg |
|
Total Plate Count |
≤ 300cfu/g |
|
Antibiotic Residue |
No residual antibiotic activity |
|
Host-Cell-Dereived-Proteins |
≤ 10 ng/mg |
|
Host Cell DNA |
≤ 10 ng/1.5mg |
|
Single-Chain Precursor |
≤ 10 ng/mg |
