Merck
All Photos(3)

1.37020

SAFC

Sodium hydroxide

pellets suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,NF

Synonym(s):
‘Caustic soda’
Linear Formula:
NaOH
CAS Number:
Molecular Weight:
40.00
Número MDL:
Número índice de la CE:
215-185-5

Nivel de calidad

500

Agency

BP
JP
NF
Ph. Eur.

densidad de vapor

>1 (vs air)

presión de vapor

<18 mmHg ( 20 °C)
3 mmHg ( 37 °C)

línea de producto

EMPROVE® Bio

ensayo

≥98.0-100.5% (total alkilinity calculated as NaOH)

formulario

solid

pH

>14 (20 °C, 100 g/L in H2O)

mp

318 °C (lit.)

solubilidad

water: 1090 g/L at 20 °C

densidad

2.13 g/cm3 at 20 °C

trazas de anión

carbonate (as Na2CO3): ≤0.5%
chloride (Cl-): ≤0.015%
phosphate (PO43-): ≤0.001%
silicate (as SiO2): ≤0.01%
sulfate (SO42-): ≤0.010%

trazas de catión

Al: ≤0.001%
As: ≤0.0003%
Ca: ≤0.005%
Cu: ≤0.0005%
Fe: ≤0.0010%
Hg: ≤0.00001%
K: ≤0.05%
Mg: ≤0.002%
Ni: ≤0.001%
Pb: ≤0.00005%
Zn: ≤0.0025%
heavy metals (as Ag): ≤0.002%
heavy metals (as Pb): ≤0.0005%

application(s)

biopharma process and formulation
liquid formulation
parenterals
pharmaceutical

temp. de almacenamiento

15-25°C

SMILES string

[OH-].[Na+]

InChI

1S/Na.H2O/h;1H2/q+1;/p-1

InChI key

HEMHJVSKTPXQMS-UHFFFAOYSA-M

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Descripción general

We offer a range of high quality critical raw materials, solvents and reagents plus the documentation and expertise to meet stringent regulatory requirements. In addition to our comprehensive portfolio, we also offer custom manufacturing services to meet your exact needs. 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.

Aplicación

Sodium hydroxide pellets are used in cleaning in place (CIP) applications as well as for pH-adjustment. Sodium hydroxide pellets Emprove® Essential is manufactured according to GMP guidelines and is suitable for pharmaceutical and biopharmaceutical processes.

Información legal

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

pictogramas

Corrosion

Palabra de señalización

Danger

Frases de peligro

Clasificaciones de peligro

Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1A

Código de clase de almacenamiento

8B - Non-combustible, corrosive hazardous materials

WGK

WGK 1

Punto de inflamabilidad F

Not applicable

Punto de inflamabilidad C

Not applicable

Certificate of Analysis

Enter Lot Number to search for Certificate of Analysis (COA).

Certificate of Quality

Enter Lot Number to search for Certificate of Quality (COQ).

What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials.

Material Qualification Dossier

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Quality Management Dossier

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Operational Excellence Dossier

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Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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