Benzene Sulfonic Acid

Benzene Sulphonic Acid is an off-white to white waxy crystalline solid which has low endotoxins making it suitable for parenteral applications. Its uses are majorly in pharmaceutical applications including as a buffering agent, pH modifier, stabilizing agent as well as an intermediate in the preparation of API. The quality assessment process of benzene sulphonic acid at Finar includes nitrosamine and elemental impurity risk assessment along with many other parameters. All our products are manufactured under the most stringent environment, health and safety standards. We comply with the Highest Quality Standards and are an ISO 9001:2015, 14001:2015, ISO 45001:2018, ISO/IEC 17025:2017, EXCiPACT and GMP certified company.

HP, CDMF, USDMF

Applications

Benzene Sulphonic Acid is widely used in the pharmaceutical industry. Following is a list of key applications.

  • Buffering agent
  • pH Modifier
  • Stabilizing agent
  • Intermediate in preparation of API

General Information

Pharmacopeia Status : In-house product

CAS No. : 98-11-3

EC No. : 202-638-7

Appearance/Description : Off-white to white waxy crystalline solid

Molecular Formula : C6H6O3S

Molecular Mass : 158.18 g/mol

Marketed Formulation

  • Cisatracurium Besilate injection
  • Atracurium Besilate injection and more...

Quality and Regulatory Support

  • GMP and ISO certification
  • EXCiPACT certification
  • Nitrosamine impurity risk assessment
  • Elemental impurity risk assessment
  • Residual solvent declaration
  • Genotoxic impurity declaration
  • Vendor questionnaire and site audit
  • CMC documentation
  • Regulatory queries

Key Product Attributes

  • Manufacturing and packing under GMP environment
  • Low Endotoxin suitable for parenteral application
  • Control of TAMC & TYMC
  • Control of pathogens
  • Control of sub-visible particles
  • Control of elemental impurities as per ICH Q3D
  • Control of residual solvent

Pack Mode

100 gm and 500 gm in HDPE containers

DMF (Drug Master File)

  • USDMF registered product (DMF # 30281)
  • CDMF registered product (CDE # F20180001463)

Product Specifications (In-house)

Particulars Limit
Description Off-white to white waxy crystalline solid
Solubility Soluble in water & alcohol
Identification by IR To comply the test
Melting point 59°C - 61°C
Chloride (Cl) Not more than 0.05%
Moisture 1.0% max
Assay (HPLC) Min. 98.0% (Anhydrous basis)
Residue on ignition 0.1% max
Organic impurities; Diphenyl sulfone Not more than 2.0%
Organic impurities; Total impurities Not more than 2.0%
Iron (Fe) 0.002% max
Arsenic (As) 0.15ppm max
Lead (Pb) 0.5ppm max
Mercury (Hg) 0.15ppm max
Cadmium (Cd) 0.2ppm max
Total aerobic microbial count 100 cfu/gm max
Total combined yeast and molds count 10 cfu/gm max
E.coli Absent/gm
Salmonella Absent/10 gm
Staphylococcus aureus Absent/gm
Pseud. aeruginosa Absent/gm
Bile-tolerant gram negative bacteria Absent/gm
Bacterial endotoxins 2.5 EU/mg max
Cyclohexane as residual solvent 2000ppm max
Benzene 2ppm max

Stability and Storage Conditions

Keep container tightly closed in a cool (between 15°C–25°C), dry and well-ventilated place. Store under inert gas.

Safety and Handling Information

Wear personal protective equipment/face protection. Do not get in eyes, skin or on clothing. Use only under a chemical fume hood. Do not inhale or ingest. If swallowed, seek immediate medical assistance.

COA Product Catalogues Product Search Parenteral Applications
COA Product Catalogues Product Search Parenteral Applications