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Documentos clave

1.04163

SAFC

Cloruro de sodio

granulated, EMPROVE® EXPERT, Ph. Eur., BP, ChP, JP, USP

Fabricación farmacéutica

Sinónimos:

Halita, sal de roca, NaCl

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About This Item

Fórmula lineal:
NaCl
Número de CAS:
Peso molecular:
58.44
Beilstein/REAXYS Number:
3534976
MDL number:
UNSPSC Code:
12352302

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grade

GMO free
Halal
Kosher

Quality Level

agency

BP
ChP
JP
Ph. Eur.
USP

product line

EMPROVE® EXPERT

form

granular

mp

801 °C (lit.)

application(s)

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical
solid formulation

storage temp.

2-30°C

SMILES string

[Na+].[Cl-]

InChI

1S/ClH.Na/h1H;/q;+1/p-1

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Este artículo
1.16224PHR13211613804
agency

BP, JP, USP, ChP, Ph. Eur.

agency

BP, JP, Ph. Eur., USP

agency

traceable to USP 1613804

agency

-

form

granular

form

solid

form

-

form

-

product line

EMPROVE® EXPERT

product line

EMPROVE® EXPERT

product line

-

product line

-

grade

GMO free

grade

-

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard

mp

801 °C (lit.)

mp

801 °C (lit.)

mp

801 °C (lit.)

mp

801 °C (lit.)

General description

Standard bulk materials often show a tendency for caking, clumping and dust formation which results in laborious weighing and manual de-caking processes with a negative impact on manufacturing efficiency. Due to its granulated form, Sodium chloride granulated is free-flowing and easy to handle. Its greatly reduced caking behavior facilitates processability, speeds up manufacturing processes and increases operator safety.
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Sodium chloride is a mineral salt with broad range of applications in pharmaceutical formulations. It is typically used as an osmotic agent in liquid dosage forms e.g. for preparation of isotonic formulations, as bulking or coating agent for solid dosage forms, as well as for semi-solid dosage forms like creams.
Due to its low microbial and endotoxin limits, Sodium chloride granulated Emprove® Expert is especially suitable for high-risk applications.

Packaging

1.04163.0001 / 3x1kg / PE Bottle
1.04163.1000 / 1kg / PE Bottle
1.04163.9026 / 25kg / PE Bag in PE Drum
1.04163.9500 / 500kg / Big Bag

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

related product

Referencia del producto
Descripción
Precios

Storage Class

13 - Non Combustible Solids

wgk_germany

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable


  • ¿Qué es el programa Emprove®?

    El programa Emprove® es un sistema que proporciona documentación completa y exhaustiva de nuestros filtros y componentes de un solo uso, materias primas farmacéuticas y materiales de partida.

    Material Qualification Dossier

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    Material Qualification Dossier

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    Quality Management Dossier (Open Access)

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    Operational Excellence Dossier

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    Operational Excellence Dossier

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    Más información sobre las ventajas que le puede proporcionar una suscripción al programa Emprove®
    ¿Por qué no están disponibles estos documentos?
    Los expedientes Emprove® contienen información destinada a respaldar el proceso de registro y las actividades de evaluación del riesgo de los productores farmacéuticos y contienen información confidencial. contacte con nosotros si desea tener acceso.

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    Artículos

    Handling bulk powders at a large scale in the pharmaceutical, biopharmaceutical, and bioprocessing setting is challenging. Compared to powders, granulated materials experience far less caking, have better flowability, and are easier to handle, even after long-term storage.

    Handling bulk powders at a large scale in the pharmaceutical, biopharmaceutical, and bioprocessing setting is challenging. Compared to powders, granulated materials experience far less caking, have better flowability, and are easier to handle, even after long-term storage.

    Handling bulk powders at a large scale in the pharmaceutical, biopharmaceutical, and bioprocessing setting is challenging. Compared to powders, granulated materials experience far less caking, have better flowability, and are easier to handle, even after long-term storage.

    Handling bulk powders at a large scale in the pharmaceutical, biopharmaceutical, and bioprocessing setting is challenging. Compared to powders, granulated materials experience far less caking, have better flowability, and are easier to handle, even after long-term storage.

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