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Safety Information

1.37020

SAFC

Sodium hydroxide

pellets, EMPROVE® EXPERT, Ph. Eur., BP, ChP, NF, JP

Pharma Manufacturing

Synonym(s):

‘Caustic soda’

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About This Item

Linear Formula:
NaOH
CAS Number:
Molecular Weight:
40.00
MDL number:
UNSPSC Code:
12352305
EC Index Number:
215-185-5

Agency

BP
ChP
JP
NF
Ph. Eur.

Quality Level

vapor density

>1 (vs air)

vapor pressure

<18 mmHg ( 20 °C)
3 mmHg ( 37 °C)

description

suitable for the biopharmaceutical production

product line

EMPROVE® EXPERT

Assay

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

form

pellets
solid

pH

>14 (20 °C, 100 g/L in H2O)

mp

318 °C (lit.)

solubility

water: 1090 g/L at 20 °C

density

2.13 g/cm3 at 20 °C

anion traces

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

cation traces

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)

liquid formulation
parenterals
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


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

ISHL Indicated Name

Substances Subject to be Indicated Names

ISHL Notified Names

Substances Subject to be Notified Names

JAN Code

CO1E1370206025:
1370209013:
1370205000BWT:
1370201000:
1370209050:
1370209012:
1370200000:
1370205000:
1370206025:
1370209025:


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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