1.00164

Boric acid

cryst., EMPROVE^® API, Ph. Eur., BP, NF

• Synonym(s): Orthoboric acid, Trihydroxidoboron
• Linear Formula: H₃BO₃
• CAS Number: 10043-35-3
• Molecular Weight: 61.83
• MDL number: MFCD00011337
• EC Index Number: 233-139-2

Properties

• Agency: BP; NF; Ph. Eur.
• Quality Level: 600
• vapor pressure: 2.6 mmHg ( 20 °C)
• product line: EMPROVE^® API
• Assay: 99.5-100.5% (alkalimetric)
• form: solid
• potency: 2660 mg/kg LD₅₀, oral (Rat); >2000 mg/kg LD₅₀, skin (Rat)
• pH: 3.8-4.8 (20 °C, 33 g/L in H₂O)
• mp: 160 °C (dec.) (lit.)
• solubility: 49.2 g/L
• density: 1.489 g/cm³ at 23 °C
• bulk density: 400‑600 kg/m³
• anion traces: sulfate (SO₄^2-): ≤0.04%
• cation traces: As: ≤0.0001%; heavy metals (as Pb): ≤0.0015%
• application(s): liquid formulation; ophthalmics; parenterals; pharmaceutical; semi-solid formulation
• storage temp.: 2-25°C
• SMILES string: OB(O)O
• InChI: 1S/BH3O3/c2-1(3)4/h2-4H
• InChI key: KGBXLFKZBHKPEV-UHFFFAOYSA-N

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

Boric acid as an active ingredient is used in ophthalmic drugs, as antiseptic for cuts and burns, as well as antibacterial for dermatological treatments such as acne and athlete foot. Boric acid Emprove^® API is manufactured according to ICH Q7 guidelines. A CEP and an 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: GHS08
• Signal Word: Danger
• Hazard Statements: H360FD
• Precautionary Statements: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Repr. 1B
• 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