Active Pharmaceutical Ingredient (API)

Facilities Active Pharmaceutical Ingredient

At NSRT’s API department, our highly experienced and skilled scientists are well equipped to synthesise any API or impurities from milligram to kilogram scale using state-of-the-art facility and technologies. NSRT is one of the few R&D centres in India, capable of handling, synthesizing and storing controlled substances (narcotic & psychotropic substances). Supported by a secure IT infrastructure, e-labNotes (online data entry) and online access to scientific literature, our teams rapidly convert ideas into successful experiments and solutions.

We can offer the following services to our customers:

  • Multifunctional Reactors with SACADA system (20, 50, 100 L)
  • Heating / Cooling capability from (-50°C to +200°C)
  • Crystallizer
  • Neutsche Filter
  • Centrifuge
  • Autoclaves
  • Mobile Scrubber
  • Jacketed reactor (5 & 20 L)
  • Continuous Flow Reactor
  • Rotavopor(20 L)
  • Vacuum Tray Dryer

Customized Development & Optimization Services

Our scientists have the skill and experience to meet a wide range of outsourcing needs from the custom synthesis and scale-up of an existing route, to identification and development of new patent non-infringing manufacturing routes from scratch. We have successfully performed classical chemical reactions such as –oxidations, reductions, protection, deprotection, substitution/elimination reactions, aldol condensation, Diels-Alder cycloaddition, Friedel-Crafts acylation, Grignard reaction, Horner-Wadsworth-Emmons reaction, Knoevenagel condensation, Michael addition, Wittig reaction, etc. In addition, we also specialise in the use of chiral-, metal-, organo-, bio- &nano-catalysts enabling us to perform asymmetric synthesisand reactions at a faster rate with milder conditions.

  • Impurity control is one of the most important tasks in a process scale up. At NSRT, we have developed various approaches to controlling impurities at different stages – material control, process control, end-product testing.
  • At the heart of our development, we ensure the development of cost-effective synthesis routes by employing Quality by design (QbD) approach and an emphasis on Green chemistry.

Impurity Synthesis

Identifying and describing the impurities that are present in the API is important for safety reasons. Generally, unknown impurities have a more stringent limit for regulatory submissions. By identifying these unknown impurities, the limits could be relaxed, the origin of the impurity can be established, thereby improving the process controls and the API’s impurity profile. At NSRT, we can help you isolate, identify and synthesize and provide a well characterized and certified impurities present in the API.

Continuous Flow Reactor

“Flow chemistry” is the process of performing chemical reactions by using continuously flowing liquid/gases through a tube, rather than a batch production. Reactive components are pumped together at a mixing junction and flowed down a temperature-controlled pipe or tube. This provides some major advantages such as faster reactions, cleaner products, safer reactions and easy scale-up.

Some of the benefits of Flow chemistry are:

  • Better mixing, enhanced heat and mass transfer
  • Better conditions control
  • Better reproducibility
  • Easier automation
  • Easier conditions screening & optimization
  • Safer operation
  • Quality control
  • Less waste

Our Specialization

Our Services