The Analytical Division at Sipra is by far the best equipped laboratory in the country with capabilities to perform most of the pharmacopoeial tests,  deploying the leading equipment from world leaders. The work process is driven by robust quality management system and  operates through LIMS package, which tracks the entire laboratory work flow and data flow including specifications, raw data, test reports, quality system formats etc.  and  provides role based controlled access to all the users from its central server and a single source of data storage.


  Organic impurities & inorganic impurities are estimated at the
    levels ranging from PPM to sub PPT levels using high sensitive
    techniques like mass spectroscopy.
  Process impurities are estimated using HPLC and Ion
    Chromatography systems
  Crystallinity and Polymorphism studies are conducted using
    XRD, DSC etc. at as low as 0.1%
  Isomers are separated and quantified using Chiral HPLC
  Toxic residues are estimated with the aid of GC-MS/MS


  Method development & validations for various techniques like
    chromatography, mass spectroscopy, particle size, X-ray
    diffraction etc.
  Validations for related substance, assay, residual solvents,
    dissolution profile, trace metals, particle size distribution,
    microbiological tests, Bacterial endotoxins.
  HPLC systems with UV, flourescence detectors, RI detectors,
    conductivity detectors and PDA detectors


  Powder particles (0.5 to 2000 microns) are characterized using laser
    diffraction, light obscuration and microscopic techniques.
  Liquid Borne particulate Matter (2.0 microns to 400 microns)
    is measured as per BP, USP and IP
  Specific Surface Area and porosity by BET method


  Microbial limit tests and sterility (Equinox closed system),
    RT – PCR studies.
  Bacterial endotoxin tests using gel clot and kinetic techniques.
  Preservative efficacy testing and Antibiotic and vitamin assays.
  Air borne particle count & Microbial validation of environment by
    settling plate method


  As per IP, USP, BP, EP, JP
  Exceipient analysis
  Heavy metals by ICP-MS/ AAS including rare earth elements and
    catalyst residues


  NMR, Mass, FTIR, HATR, DSC, TGA
  XRD, CHNSO (Elemental Analysis)