BioHale® Sacarose

Alta pureza, baixa endotoxina sacarose

Biofarmacêutica

Informação do produto

Com BioHale® Sacarose oferecemos o excipiente de maior pureza para a estabilização de produtos biológicos a serem usados na formulação biofarmacêutica. BioHale® Sacarose é um dissacarídeo cristalino não redutor composto por uma molécula de glicose e uma frutose unidas por meio de uma ligação glicosídica.

Comumente usada na indústria farmacêutica como estabilizante, a sacarose também pode ser amplamente utilizada como criopreservante e suplemento de mídia em uma variedade de bioprocessos baseados em células.

Além disso, a Sacarose BioHale® é preferida em aplicações onde questões de solubilidade ou viscosidade são de suprema importância. BioHale® Sacarose é bem adequada para proporcionar estabilização do estado de solução, bem como crio e lioproteção para proteínas terapêuticas como excipientes nas formulações. A sacarose geralmente pode ser considerada adequada geralmente, a menos que seja restringida por uma formulação de pH baixo.

BioHale® Sacarose pode ser usada em várias formas de administração, como por via parenteral, oral ou oftálmica. 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 em conformidade com os requisitos regulatórios globais da indústria farmacêutica (F. Eur., USP-NF, JP, ChP) e possuem um Arquivo Mestre de Medicamentos Chinês (cDMF).

Com BioHale® Sucrose, estamos atualmente apoiando a produção de vacinas contra a COVID-19 em todo o mundo. Leia mais: A DFE Pharma orgulhosamente apoia fornecimento de vacinas conta a COVID-19 no Paquistão

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Funcionalidade: Estabilizador
Processo recomendado: Liofilização
Formas farmacêuticas: Parenteral

Dados típicos do produto

: Plant, isolated from sugar beet

CAS number

CAS number: 57-50-1

Conformidade com monografias

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

Nível de endotoxina (EU/g)

Nível de endotoxina (EU/g): ≤ 0.25

Tg (°C)

Tg (°C): ~61

Documentação

Brochura Biohale®. Ver
Página do produto Biohale Sucrose Ver
Ausência de Melamina em Pharmacel, Superstarch e Desintegrantes
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Declaração de ausência de Aromas, Corantes, Adoçantes, Conservantes e Glicóis
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Declaração BSE BioHale (Sacarose, Trealose)
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Declaração coletiva Sacarose (alérgenos, látex etc)
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Compliance packaging
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Contaminantes Sacarose
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COS Sacarose
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País de origem Sacarose
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País de origem Sacarose
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Declaração de impurezas genotóxicas
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Declaração OGM Sacarose
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ICHQ3D impurezas elementares
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Declaração de ingredientes Sacarose
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Questionário IPEC sobre Nitrosaminas
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Nano materiais
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Ausência de exigência de US DMF
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Ausência de uso de PFC, DEHP, DINP e BPA
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Ausência de substâncias perigosas
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Declaração de estabilidade BioHale Sacarose
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Declaração de solventes residuais BioHale Sacarose
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Informações de segurança Sacarose
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BioHale® Sacarose

Informação do produto

Dados típicos do produto

CAS number

Conformidade com monografias

Nível de endotoxina (EU/g)

Tg (°C)

Documentação

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