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Safety Information

1.06482

SAFC

Sodium hydroxide

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

Pharma Manufacturing

Synonym(s):

Sodium hydroxide, Soda caustic, ‘Caustic soda’

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About This Item

Linear Formula:
NaOH
CAS Number:
1310-73-2
Molecular Weight:
40.00
MDL number:
MFCD00003548
UNSPSC Code:
12352305
E Number:
E524
EC Index Number:
215-185-5

product name

Sodium hydroxide pellets, EMPROVE® ESSENTIAL, Ph. Eur., BP, FCC, ChP, NF, JP, E 524

Agency

BP
ChP
JP
NF
Ph. Eur.

Quality Level

500

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
GHS05

Signal Word

Danger

Hazard Statements

H290,H314

Hazard Classifications

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

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

危险化学品

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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