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1.06400

SAFC

Sodium chloride

EMPROVE® ESSENTIAL, Ph. Eur., BP, USP

Pharma Manufacturing

Synonym(s):

Halite, NaCl

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About This Item

Linear Formula:
NaCl
CAS Number:
7647-14-5
Molecular Weight:
58.44
Beilstein:
3534976
MDL number:
MFCD00003477
UNSPSC Code:
12352302
EC Index Number:
231-598-3
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Agency

BP
Ph. Eur.
USP

Quality Level

500

vapor pressure

1.3 hPa ( 865 °C)

description

https://emprovesuite.com/

product line

EMPROVE® ESSENTIAL

form

solid

pH

4.5-7.0 (20 °C, 100 g/L in H2O)

bp

1461 °C/1013 hPa

mp

801 °C (lit.)

solubility

358 g/L

density

2.17 g/cm3 at 20 °C

application(s)

liquid formulation
ophthalmics
pharmaceutical

storage temp.

2-30°C

SMILES string

[Na+].[Cl-]

InChI

1S/ClH.Na/h1H;/q;+1/p-1

InChI key

FAPWRFPIFSIZLT-UHFFFAOYSA-M

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General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
As part of our EMPROVE® 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 chloride is a mineral salt with broad range of applications in pharmaceutical formulations. It is typically used as an osmotic agent in liquid dosage forms e.g. for preparation of isotonic formulations, as bulking or coating agent for solid dosage forms, as well as for semi-solid dosage forms like creams.

Legal Information

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

Storage Class Code

13 - Non Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials. Four document types are included with an Emprove® Program subscription:

Material Qualification Dossier

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Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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Successfully Navigate the Regulatory Landscape for Chemicals and Single-Use Consumables

This page summarizes key considerations related to regulatory expectations for biomanufacturing including chemicals and polymeric materials. For chemicals, topics include nitrosamines and elemental impurities, and for polymeric materials such as filters and single-use assemblies, the focus is qualification and extractable and leachable testing.

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