NO. | Productos | CAS No. | Solicitud | Indicador de calidad de clave | ||||
Pureza | Isómero | Si * | Max * | Humedad | ||||
1 | FMOC-LYS (MTT) -OH | 167393-62-6 | Modificación de la cadena lateral de lisina | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤1.0% |
2 | Fmoc-lys (alloc) -oh | 146982-27-6 | Modificación de la cadena lateral de lisina | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
3 | FMOC-LYS (IVDDE) -OH | 150629-67-7 | Modificación de la cadena lateral de lisina | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
4 | FMOC-LYS (MMT) -OH | 159857-60-0 | Modificación de la cadena lateral de lisina | ≥98.0% | ≤0.2% | ≤0.3% | ≤0.5% | ≤1.0% |
5 | Fmoc-glu-otbu | 84793-07-7 | LiraglutidaSemaglutida | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
6 | Glu-otbu | 45120-30-7 | LiraglutidaSemaglutida | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤1.0% |
7 | Ácido octadecánico | 871-70-5 | Semaglutida | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
8 | Ácido octadecanediico mono-tert-butyl éster | 843666-40-0 | Semaglutida | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
9 | TBU-OOC-C16-CO-GLU-OTBU | 1188328-39-3 | SemaglutidaFragmento a | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
10 | AEEA | 134978-97-5 | SemaglutidaAlbuvirtide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
11 | Aeea-oh.hcl | 134979-01-4 | SemaglutidaAlbuvirtide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
12 | FMOC-AEEA-OH | 166108-71-0 | SemaglutidaAlbuvirtide | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
13 | Boc-aea-oh | 108466-89-3 | Semaglutida | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
14 | Aeea-aea | 1143516-05-5 | Semaglutida | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
15 | FMOC-AEEA-AEEA-OH | 560088-89-3 | SemaglutidaFragmento B | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
16 | Octa (otbu) -gulu (ɑ-otbu) -aeea-aea-oh | 1118767-16-0 | SemaglutidaFragmento C | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
17 | tbu-ooc-c16-co-glu (aeea-aeaa-nhs) -otbu | 1118767-15-9 | SemaglutidaFragmento 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 | Fragmento semaglutida e | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
19 | Boc-his (trt) -oh | 32926-43-5 | El final es histidina | ≥99.5% | ≤0.1% | ≤0.1% | ≤0.2% | ≤4.0% |
20 | FMOC-AIB-OH | 94744-50-0 | Semaglutida | ≥99.5% | / | ≤0.1% | ≤0.2% | ≤1.0% |
21 | Boc-his (TRT) -aiB-oh | 2061897-68-3 | Semaglutida | ≥99.0% | ≤0.1% | ≤0.2% | ≤0.3% | ≤2.0% |
22 | Fmoc-glu (otbu) -gly-oh | 866044-63-5 | Análogo GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
23 | Boc-his (trt) -aib-glu (otbu) -gly-oh | 1169630-31-2? | Fragmento semaglutida f | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
24 | Boc-his (trt) -aib-glu (otbu) -gly-nhs | 1169630-40-3 | Fragmento semaglutida g | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
25 | Fmoc-arg (pbf) -gly-oh | 660846-80-0 | Análogo GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
26 | Fmoc-ala-ala-oh | 87512-31-0 | Análogo GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
27 | Fmoc-thr (tbu) -phe-oh | 1260609-75-3? | Análogo GLP-1 | ≥99.5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
28 | Ácido palmítico | 1957/10/3 | Fragmento de liraglutida 1 | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
29 | Palm-glu-otbu | NA | Fragmento de liraglutida 2 | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
30 | Palm-Glu (NES) -Otbu | NA | Fragmento de liraglutida 3 | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
31 | FMOC-LYS (PALM-GLU-OTBU) -OH | 1491158-62-3 | Liraglutida | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
32 | Ácido hexadecánico | 505-54-4 | Insulina degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
33 | Ácido hexadecanediico mono-tert-butil éster | 843666-27-3 | Insulina degludec | ≥99.0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
34 | TBU-OOC-C14-Co-Glu-OTBU | NA | Insulina degludec fragment i | ≥98.0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
35 | TBU-OOC-C14-Co-Glu (NES) -OTBU | NA | Insulina degludec Fragment II | ≥96.0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
Si *= impureza específica
Max*= max impureza desconocida
Otro indicador:
- Ácido acético: ≤0.02% (todos los productos)
- Acetato de etilo: ≤0.5% (todos los productos)
- Alcohol: ≤0.5% (todos los productos)
La desinfección del sistema de distribución, incluido el bucle y el tanque de almacenamiento, se realiza mediante pasteurización. Cuando se realiza la desinfección de la pasteurización, el agua purificada en el tanque se calienta hasta 80 ° C y comienza a circular por el sistema de distribución. La desinfección dura 1 hora después de alcanzar los 80 ° C. La desinfección se realiza cada trimestre. El libro de registro de desinfección del sistema de agua purificado se verificó sin excursión.