1.06441

Sodium fluoride

EMPROVE^® API Ph Eur,BP,USP

• Synonym(s): Sodium fluoride
• Empirical Formula (Hill Notation): FNa
• CAS Number: 7681-49-4
• Molecular Weight: 41.99
• MDL number: MFCD00003524
• EC Index Number: 231-667-8

Properties

• 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
• InChI: 1S/FH.Na/h1H;/q;+1/p-1
• InChI key: PUZPDOWCWNUUKD-UHFFFAOYSA-M

Description

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

Safety Information

• Pictograms: GHS06
• Signal Word: Danger
• Hazard Statements: H301 - H315 - H319
• Precautionary Statements: P264 - P280 - P301 + P310 - P302 + P352 - P305 + P351 + P338 - P332 + P313
• 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