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Key Documents

Safety Information

1.37017

SAFC

Sodium chloride

EMPROVE® EXPERT, Ph. Eur., BP, ChP, JP, USP

Pharma Manufacturing

Synonym(s):

Halite, NaCl

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About This Item

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

Agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

vapor pressure

1.3 hPa ( 865 °C)

product line

EMPROVE® EXPERT

form

solid

feature

RNase and DNase free

pH

4.5-7.0 (20 °C, 100 g/L in H2O)

bp

1461 °C/1013 hPa

mp

801 °C (lit.)

density

2.17 g/cm3 at 20 °C

application(s)

liquid formulation
ophthalmics
parenterals
pharma/biopharma processes
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.
Due to its low microbial and endotoxin limits, Sodium chloride Emprove® Expert is especially suitable for high-risk applications.

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


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

1370170005:
1370170403:
1370170001:
1370174025:
MX11370175000:
1370175000BWT:
1370171000:
1370179029:
1370179012:
US11370175001:
1370176025BWT:
1370175000:
1370179051:
1370171000BWT:
1370179100:
MX11370179999:
1370173010:
1370179029BWT:
1.37017.5001:
1.37017.9012:
1370179999:
1370174100:
CO1E1370179500:
1370176025:
CO1E1370179029:
1.37017.9028:
1370170000:
1370174010:
US11370179028:
1370179500:


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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