Methane Sulphonic Acid is a clear liquid that can be colourless, pale yellow or pale brown. It has low endotoxin making it suitable for parenteral applications. It has many uses in the pharmaceutical industry including as a buffering agent, pH modifier and stabilising agent. It is also used as an intermediate in the preparation of API’s. 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
Methane Sulphonic Acid is widely used in the pharmaceutical industry.
General Information
Pharmacopeia Status : In-house product
CAS No. : 75-75-2
EC No. : 200-898-6
Appearance/Description : Clear colourless to pale yellow, pale brown or pale brownish yellow clear liquid
Molecular Formula : CH4O3S
Molecular Mass : 96.10 g/mol
Marketed Formulation
Quality and Regulatory Support
Key Product Attributes
Pack Mode
DMF (Drug Master File)
Product Specifications (In-house)
Particulars | Limit |
---|---|
Description | Clear colourless to pale yellow, pale brown or pale brownish yellow clear liquid |
Solubility | Miscible with water, slightly soluble in toluene, practically insoluble in hexane |
Identification A (By IR) | IR absorption spectrum of the test preparation should exhibit the maxima only at the same wave number as that of the standard preparation of Methane Sulphonic Acid |
Assay | 98.0% - 102.0% |
Sulphate (SO4) | 50ppm max |
Chloride (Cl) | 10ppm max |
Residue on ignition | 0.1% max |
Density, 20°C | 1.478 - 1.482 |
Cadmium (Cd) | 0.2ppm max |
Lead (Pb) | 0.5ppm max |
Arsenic (As) | 1.5ppm max |
Mercury (Hg) | 3.0ppm max |
Bacterial endotoxins test | 0.5 EU/mg max |
Total aerobic microbial count | 100 CFU/ml max |
Total combined yeast and molds count | 100 CFU/ml max |
Stability and Storage Conditions
Store in a segregated and approved area which is cool and well-ventilated. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition.
Safety and Handling Information
Keep container dry. Do not ingest or inhale the gas / fumes or vapour. Do not add water to the product. In case of insufficient ventilation always wear suitable respiratory equipment. If ingested, seek medical advice immediately. Avoid contact with skin and eyes.