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1.37020

氢氧化钠

Name: 氢氧化钠
Brand: MM

pellets, EMPROVE^® EXPERT, Ph. Eur., BP, ChP, NF, JP

别名:

‘苛性钠’

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关于此项目

线性分子式:

NaOH

化学文摘社编号:

1310-73-2

分子量:

40.00

UNSPSC Code:

12352305

EC Index Number:

215-185-5

MDL number:

MFCD00003548

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属性

Quality Segment

500

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 (PO₄^3-): ≤0.001%, silicate (as SiO₂): ≤0.01%, sulfate (SO₄^2-): ≤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

说明

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 cell culture, purification, and formulation steps.
In viral inactivation steps due to its strong denaturing properties.
In cleaning in place (CIP) applications as well as for pH adjustment.

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

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

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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

存储类别

8B - Non-combustible corrosive hazardous materials

flash_point_f

Not applicable

flash_point_c