IndiRAM Raman Spectrometer for identification of Excipients in Pharmaceutical Drugs
In the realm of pharmaceuticals, two critical components come together to create effective and safe medications: the Active Pharmaceutical Ingredient (API) and excipients. While the API is the primary substance responsible for the therapeutic effect, excipients on the other hand, are inert substances that are combined with the API to create a final drug product that is stable, effective, and manufacturable.
For a typical muscle relaxant, the list of ingredients will include names like Ibuprofen, Paracetamol, and Chlorzoxazone. These are APIs, however, the excipient details are often not listed on the packaging since they are inactive. The excipients become very critical when the Central Drugs Standard Control Organization (CDSCO), India's regulatory body for pharmaceutical drugs, conducted a study on excipients and determined that some of them, although supposedly inactive, may still have a known action or effect in some circumstances. Accordingly, CDSCO is mulling mandating the mention of excipients on the strip of medicine for its safe use. Thus, it is extremely important to know excipients, not just the APIs.
This is where the IndiRAM™ Raman Spectrometer comes into play. At TechnoS Instruments, we have conducted an extensive study of various pharmaceutical drugs and compiled a comprehensive library of common excipients found in these medications. The IndiRAM™ Raman Spectrometer is a potent tool for the quick identification of excipients, aiding CDSCO in its efforts to mandate excipient listings and effectively enforce new regulations.
For the pharmaceutical industry, the IndiRAM™ Raman Spectrometer offers a quick and reliable method for identifying excipients in manufactured drugs, ensuring compliance with CDSCO rules in a timely manner. Developed by IIT Alumni scientists, this Made-in-India spectrometer meets world standards, empowering the Indian pharmaceutical industry to swiftly adapt to potential regulatory changes.
In our study, the IndiRAM™ Raman Spectrometer has successfully identified several widely used excipients, such as
- Stearic Acid, widely used as an emulsifier or lubricating agent,
- Sodium Methyl Paraben, an antimicrobial preservative and
- Sodium Methyl Paraben, also an antimicrobial preservative.
Beyond identifying excipients, the IndiRAM™ Raman Spectrometer can also rapidly and accurately identify various APIs. This capability makes it an invaluable tool throughout the drug production process, from the entry of APIs and excipients into the production chain to the final packaging of drugs for distribution. The integration of Raman spectroscopy into pharmaceutical quality control processes represents a significant advancement in ensuring drug safety and compliance. The IndiRAM™ Raman Spectrometer stands out as a critical instrument in this effort, providing precise and efficient identification of both excipients and APIs. As regulatory bodies like CDSCO consider new requirements for excipient disclosure, tools like the IndiRAM™ Raman Spectrometer will play a vital role in supporting the pharmaceutical industry's commitment to transparency and quality.
