Aminoácido protegido con GLP-1 para la modificación de la cadena lateral
Detalle del producto
| NO. | productos | No CAS. | Solicitud | Indicador clave de calidad | ||||
| Pureza | isómero | SI * | máx. * | 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 octadecanodioico | 871-70-5 | semaglutida | ≥99,0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 8 | Éster mono-terc-butílico del ácido octadecanodioico | 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 | semaglutidaalbuvirtida | ≥99,0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 11 | AEEA-OH.HCl | 134979-01-4 | semaglutidaalbuvirtida | ≥99,0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 12 | Fmoc-AEEA-OH | 166108-71-0 | semaglutidaalbuvirtida | ≥99,0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 13 | Boc-AEEA-OH | 108466-89-3 | semaglutida | ≥99,0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 14 | AEEA-AEEA | 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)-Glu(ɑ-OtBu)-AEEA-AEEA-OH | 1118767-16-0 | semaglutidaFragmento C | ≥98,0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 17 | tBu-OOC-C16-CO-Glu(AEEA-AEEA-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 | Semaglutida Fragmento E | ≥96,0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 19 | Boc-His(Trt)-OH | 32926-43-5 | El fin es la 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 de 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 F de semaglutida | ≥98,0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 24 | Boc-His(Trt)-Aib-Glu(OtBu)-Gly-NHS | 1169630-40-3 | Fragmento G de semaglutida | ≥96,0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
| 25 | Fmoc-Arg(pbf)-Gly-OH | 660846-80-0 | Análogo de GLP-1 | ≥99,5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 26 | Fmoc-Ala-Ala-OH | 87512-31-0 | Análogo de GLP-1 | ≥99,5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 27 | Fmoc-Thr(tBu)-Phe-OH | 1260609-75-3 ? | Análogo de GLP-1 | ≥99,5% | ≤0.1% | ≤0.2% | ≤0.2% | ≤1.0% |
| 28 | Ácido palmítico | 1957/10/3 | Liraglutida Fragmento 1 | ≥99,0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 29 | Palma-Glu-OtBu | NA | Liraglutida Fragmento 2 | ≥98,0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 30 | Palma-Glu(NES)-OtBu | NA | Liraglutida Fragmento 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 hexadecanodioico | 505-54-4 | Insulina degludec | ≥99,0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 33 | Éster mono-terc-butílico del ácido hexadecanodioico | 843666-27-3 | Insulina degludec | ≥99,0% | / | ≤0.2% | ≤0.3% | ≤1.0% |
| 34 | tBu-OOC-C14-CO-Glu-OtBu | NA | Insulina degludec Fragmento I | ≥98,0% | ≤0.2% | ≤0.5% | ≤0.5% | ≤1.0% |
| 35 | tBu-OOC-C14-CO-Glu(NES)-OtBu | NA | Insulina degludec Fragmento II | ≥96,0% | ≤0.5% | ≤1.0% | ≤1.0% | ≤1.0% |
SI *= Impureza Específica
Máx.*= Máx. 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)
Desinfección
La desinfección del sistema de distribución, incluido el circuito y el tanque de almacenamiento, se realiza mediante pasteurización.Cuando se realiza la higienización por pasteurización, el agua purificada en el tanque se calienta hasta 80°C y comienza a circular por el sistema de distribución.La higienización dura 1 hora después de alcanzar los 80°C.La sanitización se realiza cada trimestre.Se revisó el libro de registro de sanitización del sistema de agua purificada y no se destacó ninguna desviación.
