Merck
All Photos(3)

1.06482

SAFC

Sodium hydroxide pellets

EMPROVE® ESSENTIAL, Ph. Eur., BP, FCC, JP, NF, E 524

Synonym(s):
Sodium hydroxide, Soda caustic, ‘Caustic soda’
Linear Formula:
NaOH
CAS Number:
Molecular Weight:
40.00
MDL number:
E Number:
E524
EC Index Number:
215-185-5

Agency

BP
JP
NF
Ph. Eur.

Quality Level

reg. compliance

FCC

vapor density

>1 (vs air)

vapor pressure

<18 mmHg ( 20 °C)
3 mmHg ( 37 °C)

product line

EMPROVE® ESSENTIAL

assay

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

form

solid

quality

E 524

technique(s)

HPLC: suitable

pH

>14 (20 °C, 100 g/L in H2O)

mp

318 °C (lit.)

solubility

1090 g/L

density

2.13 g/cm3 at 20 °C

anion traces

carbonate (as Na2CO3): ≤0.5%
chloride (Cl-): ≤0.015%
phosphate (PO43-): ≤0.002%
silicate (as SiO2): ≤0.01%
sulfate (SO42-): ≤0.010%

cation traces

Al: ≤0.001%
As: ≤0.0003%
Cu: ≤0.0005%
Fe: ≤0.0010%
Hg: ≤0.00001%
K: ≤0.1%
Pb: ≤0.00005%
Zn: ≤0.0025%
heavy metals (as Pb): ≤0.0005%

application(s)

liquid formulation
ophthalmics
pharma/biopharma processes
pharmaceutical

storage temp.

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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General description

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.

Application

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.

Legal Information

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

Pictograms

Corrosion

Signal Word

Danger

Hazard Statements

Hazard Classifications

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

Storage Class Code

8B - Non-combustible, corrosive hazardous materials

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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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