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 Actylis 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.
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
Quality and Regulatory Support
Key Product Attributes
Pack Mode
100 gm and 500 gm in HDPE containers
DMF (Drug Master File)
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.
