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)