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Supported by:Department of Scientific and Industrial Research (DSIR), Government of India, and the Council of Scientific and Industrial Research (CSIR).

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Product Characterization
Development of standard testing procedure, batch release specification and in-process quality control SOP. All pharmacopoeial tests, excipient compatibility, stability, photostability, CQA, CPP, STP, BRS, MSDS development.

The facility offers

  • High-end spectroscopy (IR, NMR, mass)
  • Microscopy (scanning/ transmission, atomic force, confocal, fluorescence, optical),
  • Chromatography (LC-MS/MS, GC-FID/MS, HPLC)
  • Differential Scanning Calorimetry
  • Per-monograph testing for batch release
  • Development of Standard Analytical Protocol (SAP/STP) for NCEs
  • Raw Material Testing (see case study)
  • IPQC protocol development and validation
  • Solid state characterization.
  • Metal analysis by AS.
  • Development of Product Monograph
  • Excipient compatibility, stability, photostability, CQA, CPP, STP, BRS, MSDS development
View Form 37

Case Study: Glycerin I.P.

  • Glycerin IP is required as inactive ingredient in several formulations. Also, retail-packaged by many MSME as OTC humectant.
  • MSME client in Lucknow was offered bulk quantity of Glycerin IP at competitive price.
  • We carried out Raw Material Characterization on request
  • Per-monograph testing (titration) indicated borderline compliance with IP.
  • FT-IR and GC showed impurity of ethylene glycol
  • Client decided not to procure from that vendor due to risk of NSQ material unless IR and GC is done for each batch of RM