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Safety Information

1.06441

SAFC

Sodium fluoride

EMPROVE® API Ph Eur,BP,USP

Pharma Manufacturing

Synonym(s):

Sodium fluoride

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About This Item

Empirical Formula (Hill Notation):
FNa
CAS Number:
7681-49-4
Molecular Weight:
41.99
MDL number:
MFCD00003524
UNSPSC Code:
12352302
EC Index Number:
231-667-8

Agency

BP
Ph. Eur.
USP

Quality Level

600

vapor pressure

1 hPa ( 1077 °C)

product line

EMPROVE® API

form

crystals

potency

148.5 mg/kg LD50, oral (Rat)

pH

10.2 (20 °C, 40 g/L in H2O)

mp

996 °C

density

2.8 g/cm3 at 20 °C

application(s)

liquid formulation
pharmaceutical
semi-solid formulation
solid formulation

storage temp.

2-25°C

SMILES string

[Na+].[F-]

InChI

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

InChI key

PUZPDOWCWNUUKD-UHFFFAOYSA-M

Related Categories

General description

We provide industry-leading production know-how and comprehensive regulatory support for high-quality APIs, backed by nearly 200 years of experience. From a complete portfolio of innovative folates to custom synthesis, our customized and scalable solutions meet your specific production needs. 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 fluoride is used in mouth hygiene, as a trace element for fluoride source in clinical nutrition and in dietary supplements. Sodium fluoride Emprove® API is manufactured according to ICH Q7 guidelines. A CEP and US-DMF are available.

Legal Information

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

Pictograms

Skull and crossbones
GHS06

Signal Word

Danger

Hazard Statements

H301,H315,H319

Hazard Classifications

Acute Tox. 3 Oral - Eye Irrit. 2 - Skin Irrit. 2

Supplementary Hazards

EUH032

Storage Class Code

6.1D - Non-combustible acute toxic Cat.3 / toxic hazardous materials or hazardous materials causing chronic effects

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.

PDSCL

Deleterious substance

PRTR

Class I Designated Chemical Substances

ISHL Indicated Name

Substances Subject to be Indicated Names

ISHL Notified Names

Substances Subject to be Notified Names

JAN Code

MX11064411000:
1064419025:
1064410001:
1064411003:
1064419023:
1064410000:
1064411000:

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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