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关于此项目
产品名称
氢氧化钠颗粒, EMPROVE® ESSENTIAL, Ph. Eur., BP, FCC, ChP, JP, NF, E 524
Quality Segment
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 (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%
SMILES string
[OH-].[Na+]
application(s)
liquid formulation
ophthalmics
pharma/biopharma processes
pharmaceutical
storage temp.
15-25°C
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 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
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signalword
Danger
hcodes
Hazard Classifications
Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1A
flash_point_f
Not applicable
flash_point_c
Not applicable
存储类别
8B - Non-combustible corrosive hazardous materials
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