Pharmatose® 200M

Lactose mono-hidratada altamente consistente

Boas propriedades de compactação,

Ofertas de vários locais de produção

Dose Sólida Oral

Informação do produto

Pharmatose® e Lactochem® são as marcas da DFE Pharma para graus de mono-hidratos brancos puros e altamente cristalinos, moídos. A lactose é mecanicamente moída em diferentes graus de tamanhos de partículas, permitindo que as empresas farmacêuticas escolham o grau que melhor se adapta às necessidades de sua formulação. Devido à natureza fina e área de superfície relativamente alta, a lactose moída compacta bem. Esse tipo de lactose é normalmente usado em comprimidos, cápsulas e esferonização por extrusão.

Tipos de Produto: Lactose moída
Funcionalidade: Enchimento-aglutinante, Diluente, Fichário
Processo recomendado: Granulação úmida, Esferonização por extrusão, Processamento contínuo
Formas farmacêuticas: Comprimidos, Cápsula (Dose Oral Sólida)

Dados típicos do produto

X10: 5
X50: 40
X90: 120

Densidade aparente (g/L)

Densidade aparente (g/L): 589

Hausner ratio (-)

Hausner ratio (-): 1.46

Documentação

Brochura de Dose Oral Sólida
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Folheto Dose Oral Sólida - Lactose Moída Ver
Alba Lactose Farmacêutica
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Contaminantes de Pharmatose, Respitose e Supertab (UE)
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FSSC 22000 FrieslandCampina DMV Veghel
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Declaração de OGM da lactose Ver
Declaração de Ingrediente de Lactose
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FISPQ da Lactose mono-hidratada
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Informação nutricional da lactose
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Solvente residual da lactose
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Declaração de prazo de validade da lactose
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Product Specification Pharmatose 200M EU Ver

Process Flow Sheet Pharmatose 200M EU Ver
Process Flow Sheet (PFS) Milled lactose Ver

GMP+ FrieslandCampina DMV B.V. Veghel Ver
ISO 14001 FrieslandCampina DMV Veghel Ver
ISO 9001 FrieslandCampina DMV Veghel Ver
ICHQ3D Elemental Impurities Lactose EU and NZ Ver
Free from Foot and Mouth Disease lactose Ver
World anti-doping code Ver
Non dangerous substance Ver
cGMP Statement Ver
BSE Statement Lactose & Inhalation Ver
Irradiation free Ver
Contaminants and residues lactose Ver
Change management Ver
Dioxin statement lactose Ver
Production site statement Ver
Data Integrity Ver
Certificate of suitability Ver
Latex free statement Ver
Genotoxic impurities Ver
Compliance packaging Ver
REACH statement Ver
Statement of business continuity planning Ver
Origin of Milk Ver
Absence of Melamine Lactose Ver

Wet granulation of milled lactose Ver
Re-compaction properties of lactose and mcc Ver
Impact of excipient and blend properties on feeding consistency for continuous manufacturing Ver

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Pharmatose® 200M

Informação do produto

Embalagem

Validade

Local de produção

Dados típicos do produto

Densidade aparente (g/L)

Hausner ratio (-)

Documentação

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