1.06482

Sodium hydroxide

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

• Synonim(y): Sodium hydroxide, Soda caustic, Caustic soda
• Wzór liniowy: NaOH
• Numer CAS: 1310-73-2
• Masa cząsteczkowa: 40.00
• UNSPSC Code: 12352305
• E Number: E524
• EC Index Number: 215-185-5
• MDL number: MFCD00003548

Właściwości

• Nazwa produktu: Sodium hydroxide pellets, EMPROVE^® ESSENTIAL, Ph. Eur., BP, FCC, ChP, NF, JP, E 524
• Quality Level: 500
• agency: BP, ChP, JP, NF, Ph. Eur.
• 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 (PO₄^3-): ≤0.002%, silicate (as SiO₂): ≤0.01%, sulfate (SO₄^2-): ≤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

Opis

General description

Every bio-manufacturing process involves buffer preparation, pH adjustment, and cleaning. All our respective GMP (IPEC/EXCiPACT) products are manufactured under Excipient GMP conditions and feature low bioburden levels, backed by our Emprove^® Program for exceptional quality and documentation support.

As a result, you can integrate our products directly into your biopharmaceutical production process. In addition to our comprehensive portfolio, we also offer custom manufacturing services to meet your exact needs.

Application

Sodium hydroxide pellets can be used:

• As a raw material to prepare various buffer solutions and reagents required for purification, cell culture and formulation steps.
• To adjust the pH of process solutions and final formulation.
• As a reagent for cleaning the equipment and piping in bioprocessing facilities to protect equipment and prevent cross-contamination.
• Its strong alkalinity effectively removes organic residues, proteins, and other contaminants from process equipment.

Features and Benefits

• Comprehensive, up-to-date documentation to navigate regulatory challenges, manage risks, and improve processes.
• Suitable for moderate-risk applications.
• Emprove^® products are designed to facilitate compliance with global regulations (e.g., ICH Q7, EU GMP, USP, EP).
• Detailed supply chain and manufacturing information helps ensure traceability and continuity, which is critical for GMP manufacturing.

Legal Information

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

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Informacja o środkach bezpieczeństwa

• pictograms: GHS05
• signalword: Danger
• hcodes: H290,H314
• pcodes: P234 - P260 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338
• Hazard Classifications: Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1A
• flash_point_f: Not applicable
• flash_point_c: Not applicable
• Klasa składowania: 8B - Non-combustible corrosive hazardous materials