BioHale® Trealose Di-hidratada

Alta pureza, baixa endotoxina Trealose Di-hidratada

Biofarmacêutica

Informação do produto

Com BioHale® Trealose Di-hidratada oferecemos o excipiente de maior pureza para a estabilização de produtos biológicos em formulações biofarmacêuticas. BioHale® Trealose Di-hidratada é um dissacarídeo formado por uma ligação 1,1-glicosídica entre duas unidades de α-glicose. É um açúcar não redutor que não é facilmente hidrolisado pelo ácido, e a ligação glicosídica não é clivada pela α-glucosidase.

BioHale® Trealose Di-hidratada é adequado para uso em uma ampla variedade de vias de administração, incluindo parenteral, inalação e oftálmica. Em particular, é comumente usada para a lioproteção e crioproteção de proteínas terapêuticas, especialmente para administração parenteral.

Outras aplicações incluem o uso como agente estabilizante durante o congelamento-descongelamento e liofilização de lipossomas; e para estabilização de células sanguíneas, bem como anticorpos monoclonais. Além de nosso portfólio de excipientes, os clientes se beneficiam de nossas soluções técnicas e suporte regulatório para desbloquear sua vantagem competitiva.

Nossos excipientes BioHale® estão conforme os requisitos regulatórios globais da indústria farmacêutica (F. Eur., USP-NF, JP, ChP) e possuem um Arquivo Mestre de Medicamentos Chinês (cDMF).

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Funcionalidade: Estabilizador
Processo recomendado: Liofilização
Formas farmacêuticas: Parenteral

Dados típicos do produto

CAS number

CAS number: 6138-23-4

Conformidade com monografias

Conformidade com monografias: Ph. Eur., USP-NF, JP, ChP

Nível de endotoxina (EU/g)

Nível de endotoxina (EU/g): ≤ 0.3

Tg (°C)

Tg (°C): ~107

Documentação

Brochura Biohale®. Ver
Página do produto Biohale Trehalose Ver
Ausência de Melamina em Pharmacel, Superstarch e Desintegrantes
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Declaração BSE BioHale (Sacarose, Trealose)
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Declaração coletiva Trealose
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Declaração de contaminantes Trealose
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COS Trealose
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País de origem Sacarose
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Declaração de impurezas genotóxicas
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Declaração OGM Trealose
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ICHQ3D Impurezas Elementares Amidos
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Declaração de ingredientes Trealose
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Questionário IPEC sobre Nitrosaminas
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Solventes residuais
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Informações de segurança Trealose
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