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Safety Information

1.00164

SAFC

Boric acid

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

Pharma Manufacturing

Synonym(s):

Orthoboric acid, Trihydroxidoboron

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About This Item

Linear Formula:
H3BO3
CAS Number:
10043-35-3
Molecular Weight:
61.83
MDL number:
MFCD00011337
UNSPSC Code:
12352106
EC Index Number:
233-139-2

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 (SO42-): ≤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

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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

Pictograms

Health hazard
GHS08

Signal Word

Danger

Hazard Statements

H360FD

Hazard Classifications

Repr. 1B

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

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Certificates of Analysis (COA)

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