1.00713

Sulfuric acid

95-98%, EMPROVE^® ESSENTIAL, Ph. Eur., BP, JPE, NF

• Synonym(s): Sulfuric acid
• Linear Formula: H₂SO₄
• CAS Number: 7664-93-9
• Molecular Weight: 98.08
• EC Index Number: 231-639-5
• UNSPSC Code: 12352301
• Beilstein/REAXYS Number: 2037554
• MDL number: MFCD00064589

Properties

• Quality Level: 500
• agency: BP, JPE, NF, Ph. Eur., suitable for EPA 1613
• vapor density: <0.3 (25 °C, vs air)
• vapor pressure: 0.0001 hPa ( 20 °C), 1 mmHg ( 146 °C)
• product line: EMPROVE^® ESSENTIAL
• assay: 95-98% (alkalimetric)
• form: liquid
• concentration: 95-98%
• technique(s): API processing | salt formation: suitable
• pH: 0.3 (25 °C, 49 g/L in H₂O)

Description

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

Sulfuric acid can be used as acidifying agent in a variety of pharmaceutical formulations and processes.

Analysis Note

Adjustment of limit values for Pb and V:

• Pb (lead) old: ≤ 0.0005% new: ≤ 0.000050% (30% Opt.1Limit: 0.000015%)
• V (vanadium)* old: ≤ 0.0002% new ≤ 0.00010% (30% Opt.1 limit: 0.00003%)

The cations are harmonised with the limit values of ICH Q3D, the batch values are set to 30% of the Option 1 limit in each case.

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: GHS05
• signalword: Danger
• hcodes: H290,H314
• pcodes: P234 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338 - P363
• Hazard Classifications: Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1A
• Storage Class: 8B - Non-combustible corrosive hazardous materials
• wgk: WGK 1
• flash_point_f: Not applicable
• flash_point_c: Not applicable