订购信息
Incelligent™ AF
Description:
Incelligent™ AF Insulin, Recombinant Human, EP, USP
Trade Name:
Incelligent
Species:
Recombinant Human Protein
Ash, %:
Sulphated Ash: ≤2% (dried basis)
Cell Culture and Diagnostic Product Type:
Insulin
Host Cell-derived Proteins:
≤10 ppm (tested in-process)
Zinc:
0.3–0.6% (dried basis)
Storage Temperature, °C:
-18 to -30
Bioidentity:
≥15 USP U/mg (Tested on one batch a quarter, thus no result will be given)
Human Insulin Related Impurities:
≤1%
Identification:
- Identification A: Complies (assay)
- Identification B: Complies (peptide mapping)
Proinsulin Content:
None–Not formed in the biosynthetic process
Assay:
- 95–105% (dried basis)
- Assay: ≥27.5 USP U/mg (dried basis)
Insulin Human Precursor:
<0.1% (tested in-process)
Insulin Human Methyl Ester:
<0.2% (tested in-process)
A21 Desamido human insulin:
≤1%
Bacterial Endotoxins:
<10 IU/mg
Shelf Life, months from mfg:
60
Loss on Drying:
≤10%
Protein Type:
High Molecular Proteins: ≤0.4%
Microbial Content, cfu/mL:
Bacterial Count: ≤300 CFU/g
Product Use:
For research and further manufacturing use only. It is not for use in humans.