HINDI. | Mga produkto | Cas No. | Aplikasyon | Key Quality Indicator | ||||
Kadalisayan | Isomer | SI * | Max * | Halumigmig | ||||
1 | Fmoc-Lys(Mtt)-OH | 167393-62-6 | Pagbabago sa side chain ng Lysine | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤1.0% |
2 | Fmoc-Lys(Alloc)-OH | 146982-27-6 | Pagbabago sa side chain ng Lysine | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
3 | Fmoc-Lys(ivDde)-OH | 150629-67-7 | Pagbabago sa side chain ng Lysine | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
4 | Fmoc-Lys(Mmt)-OH | 159857-60-0 | Pagbabago sa side chain ng Lysine | ≥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 | Ang dulo ay 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 | Nakakalasong asido | 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 *= Partikular na Karumihan
Max*= Max Hindi Alam na Karumihan
Iba pang Tagapagpahiwatig:
- Acetic Acid: ≤0.02% (Lahat ng Produkto)
- Ethyl Acetate: ≤0.5% (Lahat ng Produkto)
- Alkohol: ≤0.5% (Lahat ng Produkto)
Ang sanitization ng distribution system, kabilang ang loop at storage tank ay isinasagawa ng Pasteurization.Kapag isinagawa ang Pasteurization sanitization, ang purified water sa tangke ay pinainit hanggang 80°C at magsisimulang umikot sa pamamagitan ng distribution system.Ang sanitization ay tumatagal ng 1 oras pagkatapos umabot sa 80°C.Isinasagawa ang sanitization kada quarter.Ang purified water system sanitization logbook ay sinuri nang walang excursion na naka-highlight.