SuperTab® 21AN

Lactose anidra

Altamente compactável permitindo a recompactação

Adequada para drogas sensíveis à umidade

Dose Sólida Oral

Informação do produto

SuperTab® 21AN é uma lactose anidra altamente consistente. A estrutura característica contém aglomerados de microcristais de β-lactose predominantemente anidra.

Por ser uma lactose anidra possui baixo teor de umidade. Essa propriedade torna SuperTab® 21AN uma escolha popular nas formulações com IFAs sensíveis à umidade. Os baixos níveis únicos de água cristalina tornam eficiente o uso de SuperTab® 21AN com tecnologias PAT.

Tipos de Produto: Lactose anidra
Funcionalidade: Enchimento-aglutinante, Diluente, Fichário
Processo recomendado: Compressão direta, Granulação seca, Processamento contínuo
Formas farmacêuticas: Comprimidos, Cápsula (Dose Oral Sólida)

Dados típicos do produto

X10: 15
X50: 170
X90: 340

Densidade aparente (g/L)

Densidade aparente (g/L): 722

Hausner ratio (-)

Hausner ratio (-): 1.25

Documentação

Lactose Farmacêutica ALBA
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Brochura de Oral Dose Sólida Ver
Halal DFE Pharma NH
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Declaração GMO de Lactose
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ICHQ3D Impurezas Elementares Lactose EU e NZ
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Declaração de Ingrediente de Lactose
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MSDS Lactose Anidra
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MSDS Lactose Monohidratada
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DFE Leaflet OSD Supertab 21AN Ver
Especificação de produto SuperTab 21AN
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Fluxograma de proceso de Lactose Anidra
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Lactose livre de enfermidade de mão e boca
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Declaração de segurança viral de Lactose
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Declaração cGMP
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Declaração BSE de Lactose e Inalação
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Livre de irradiação
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Contaminantes e Residuos de Lactose
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Declaração de dioxina de Lactose
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Declaração de local de fabricação
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Integridade de dados
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Certificado de Suitability
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Declaração Látex free
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Impurezas Genotoxicas
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Compliance packaging
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Declaração REACH
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Declaração de planejamento de continuidade de negócios
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Origem do leite
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Ausência de Melamina
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Solventes Residuais Lactose
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Declaração de prazo de validade lactose
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Re-compaction properties of lactose and mcc Ver
Impact of excipient and blend properties on feeding consistency for continuous manufacturing Ver
Roller compaction of anhydrous lactose and mcc Ver

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