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

Synonym(s):  Sodium hydroxide, Soda caustic, ‘Caustic soda’

CAT Number: BC-221465

CAS Number: 1310-73-2                     Molecular Weight:  40.00         

Linear Formula: NaOH

DESCRIPTION

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 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  Essential is manufactured according to GMP guidelines and is suitable for pharmaceutical and biopharmaceutical processes.

 

Description

PROPERTIES

Agency                                 BP

                                                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                       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

SAFETY INFORMATION

Pictograms

Corrosion
GHS05

Signal Word

Danger

Hazard Statements

H290 – H314

Precautionary Statements

P234 – P260 – P280 – P303 + P361 + P353 – P304 + P340 + P310 – P305 + P351 + P338

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

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