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A propos de cet article
Quality Level
agency
BP, ChP, JP, NF, Ph. Eur.
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
concentration
(0.5 N NaOH)
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)
cleaning in place
liquid formulation
parenterals
pharma/biopharma processes
storage temp.
15-25°C
SMILES string
[OH-].[Na+]
InChI
1S/Na.H2O/h;1H2/q+1;/p-1
InChI key
HEMHJVSKTPXQMS-UHFFFAOYSA-M
General description
Application
Features and Benefits
- Comprehensive, up-to-date documentation you need to navigate regulatory challenges, manage risks, and improve processes.
- Suitable for higher-risk applications where the lowest microbiological and endotoxin levels are of utmost importance.
- 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
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signalword
Danger
hcodes
Hazard Classifications
Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1A
Classe de stockage
8B - Non-combustible corrosive hazardous materials
flash_point_f
Not applicable
flash_point_c
Not applicable
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