NO. |
Products |
CAS No. |
Application |
Key Quality Indicator |
||||
Purity |
Isomer |
SI * |
Max * |
Moisture |
||||
1 |
Fmoc-Lys(Mtt)-OH | 167393-62-6 | Lysine side chain modification |
≥99.0% |
≤0.1% |
≤0.2% |
≤0.3% |
≤1.0% |
2 |
Fmoc-Lys(Alloc)-OH | 146982-27-6 | Lysine side chain modification |
≥99.5% |
≤0.1% |
≤0.1% |
≤0.2% |
≤1.0% |
3 |
Fmoc-Lys(ivDde)-OH | 150629-67-7 | Lysine side chain modification |
≥98.0% |
≤0.2% |
≤0.3% |
≤0.5% |
≤1.0% |
4 |
Fmoc-Lys(Mmt)-OH | 159857-60-0 | Lysine side chain modification |
≥98.0% |
≤0.2% |
≤0.3% |
≤0.5% |
≤1.0% |
5 |
Fmoc-Glu-OtBu | 84793-07-7 | LiraglutideSemaglutide |
≥99.5% |
≤0.1% |
≤0.1% |
≤0.2% |
≤1.0% |
6 |
Glu-OtBu | 45120-30-7 | LiraglutideSemaglutide |
≥99.5% |
≤0.1% |
≤0.1% |
≤0.2% |
≤1.0% |
7 |
Octadecanedioic acid | 871-70-5 | Semaglutide |
≥99.0% |
/ |
≤0.2% |
≤0.3% |
≤1.0% |
8 |
Octadecanedioic acid mono-tert-butyl ester | 843666-40-0 | Semaglutide |
≥99.0% |
/ |
≤0.2% |
≤0.3% |
≤1.0% |
9 |
tBu-OOC-C16-CO-Glu-OtBu | 1188328-39-3 | SemaglutideFragment A |
≥98.0% |
≤0.2% |
≤0.5% |
≤0.5% |
≤1.0% |
10 |
AEEA | 134978-97-5 | SemaglutideAlbuvirtide |
≥99.0% |
/ |
≤0.2% |
≤0.3% |
≤1.0% |
11 |
AEEA-OH.HCl | 134979-01-4 | SemaglutideAlbuvirtide |
≥99.0% |
/ |
≤0.2% |
≤0.3% |
≤1.0% |
12 |
Fmoc-AEEA-OH | 166108-71-0 | SemaglutideAlbuvirtide |
≥99.0% |
/ |
≤0.2% |
≤0.3% |
≤1.0% |
13 |
Boc-AEEA-OH | 108466-89-3 | Semaglutide |
≥99.0% |
/ |
≤0.2% |
≤0.3% |
≤1.0% |
14 |
AEEA-AEEA | 1143516-05-5 | Semaglutide |
≥98.0% |
≤0.2% |
≤0.5% |
≤0.5% |
≤1.0% |
15 |
Fmoc-AEEA-AEEA-OH | 560088-89-3 | SemaglutideFragment B |
≥98.0% |
≤0.2% |
≤0.5% |
≤0.5% |
≤1.0% |
16 |
Octa(OtBu)-Glu(ɑ-OtBu)-AEEA-AEEA-OH | 1118767-16-0 | SemaglutideFragment C |
≥98.0% |
≤0.2% |
≤0.5% |
≤0.5% |
≤1.0% |
17 |
tBu-OOC-C16-CO-Glu(AEEA-AEEA-NHS)-OtBu | 1118767-15-9 | SemaglutideFragment D |
≥96.0% |
≤0.5% |
≤1.0% |
≤1.0% |
≤1.0% |
18 |
Fmoc-Lys(tBu-OOC-C16-CO-Glu(AEEA-AEEA)-OtBu)-OH | 1662688-20-1 | Semaglutide Fragment E |
≥96.0% |
≤0.5% |
≤1.0% |
≤1.0% |
≤1.0% |
19 |
Boc-His(Trt)-OH | 32926-43-5 | The end is histidine |
≥99.5% |
≤0.1% |
≤0.1% |
≤0.2% |
≤4.0% |
20 |
Fmoc-Aib-OH | 94744-50-0 | Semaglutide |
≥99.5% |
/ |
≤0.1% |
≤0.2% |
≤1.0% |
21 |
Boc-His(Trt)-Aib-OH | 2061897-68-3 | Semaglutide |
≥99.0% |
≤0.1% |
≤0.2% |
≤0.3% |
≤2.0% |
22 |
Fmoc-Glu(OtBu)-Gly-OH | 866044-63-5 | GLP-1 analogue |
≥99.5% |
≤0.1% |
≤0.2% |
≤0.2% |
≤1.0% |
23 |
Boc-His(Trt)-Aib-Glu(OtBu)-Gly-OH | 1169630-31-2? | Semaglutide Fragment F |
≥98.0% |
≤0.2% |
≤0.5% |
≤0.5% |
≤1.0% |
24 |
Boc-His(Trt)-Aib-Glu(OtBu)-Gly-NHS | 1169630-40-3 | Semaglutide Fragment G |
≥96.0% |
≤0.5% |
≤1.0% |
≤1.0% |
≤1.0% |
25 |
Fmoc-Arg(pbf)-Gly-OH | 660846-80-0 | GLP-1 analogue |
≥99.5% |
≤0.1% |
≤0.2% |
≤0.2% |
≤1.0% |
26 |
Fmoc-Ala-Ala-OH | 87512-31-0 | GLP-1 analogue |
≥99.5% |
≤0.1% |
≤0.2% |
≤0.2% |
≤1.0% |
27 |
Fmoc-Thr(tBu)-Phe-OH | 1260609-75-3 ? | GLP-1 analogue |
≥99.5% |
≤0.1% |
≤0.2% |
≤0.2% |
≤1.0% |
28 |
Palmitic acid | 1957/10/3 | Liraglutide Fragment 1 |
≥99.0% |
/ |
≤0.2% |
≤0.3% |
≤1.0% |
29 |
Palm-Glu-OtBu | NA | Liraglutide Fragment 2 |
≥98.0% |
≤0.2% |
≤0.5% |
≤0.5% |
≤1.0% |
30 |
Palm-Glu(NES)-OtBu | NA | Liraglutide Fragment 3 |
≥96.0% |
≤0.5% |
≤1.0% |
≤1.0% |
≤1.0% |
31 |
Fmoc-Lys(Palm-Glu-OtBu)-OH | 1491158-62-3 | Liraglutide |
≥98.0% |
≤0.2% |
≤0.5% |
≤0.5% |
≤1.0% |
32 |
Hexadecanedioic acid | 505-54-4 | Insulin degludec |
≥99.0% |
/ |
≤0.2% |
≤0.3% |
≤1.0% |
33 |
Hexadecanedioic acid mono-tert-butyl ester | 843666-27-3 | Insulin degludec |
≥99.0% |
/ |
≤0.2% |
≤0.3% |
≤1.0% |
34 |
tBu-OOC-C14-CO-Glu-OtBu | NA | Insulin degludec Fragment I |
≥98.0% |
≤0.2% |
≤0.5% |
≤0.5% |
≤1.0% |
35 |
tBu-OOC-C14-CO-Glu(NES)-OtBu | NA | Insulin degludec Fragment II |
≥96.0% |
≤0.5% |
≤1.0% |
≤1.0% |
≤1.0% |
SI *= Specific Impurity
Max*= Max Unknown Impurity
Other Indicator:
- Acetic Acid: ≤0.02% (All Products)
- Ethyl Acetate: ≤0.5% (All Products)
- Alcohol: ≤0.5% (All Products)
Sanitization of distribution system, including loop and storage tank is performed by Pasteurization. When Pasteurization sanitization is performed, the purified water in tank is heated up to 80°C and start to circulate by distribution system. The sanitization lasts 1 hour after reaching 80°C. Sanitization is performed every quarter. The purified water system sanitization logbook was checked with no excursion highlighted.