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1.00713

Sulfuric acid

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

Synonym(s):

Sulfuric acid

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About This Item

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
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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)

bp

~290 °C (lit.)

mp

-20 °C

density

1.840 g/mL at 25 °C (lit.)

anion traces

chloride (Cl-): ≤0.0002%, nitrate (NO3-): ≤0.00010%

cation traces

As: ≤0.000010%, Fe: ≤0.0002%, NH4+: ≤0.0005%, Pb: ≤0.0005%, V: ≤0.0002%, heavy metals (as Pb): ≤0.0005%

application(s)

liquid formulation
ophthalmics
pharmaceutical
semi-solid formulation

storage temp.

2-30°C

SMILES string

OS(O)(=O)=O

InChI

1S/H2O4S/c1-5(2,3)4/h(H2,1,2,3,4)

InChI key

QAOWNCQODCNURD-UHFFFAOYSA-N

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

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pictograms

Corrosion
GHS05

signalword

Danger

hcodes

H290,H314

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

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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