Analytical Development ::
This department has been accredited with the standard ISO/IEC 17025:1999 for its facilities by NABL. It is engaged in pre-formulation, stability and degradation studies on bulk drugs, preparation of the Drug Master File and Dossiers for registration in India and other countries.
Analytical Development at Torrent R&D Center is fully capable of handling various tasks and provides specific services to various departments of the centre (Medicinal Chemistry, Pharmaceutics, Pre-Clinical Safety Evaluation, Clinical Research & Biotechnology), Torrent Pharmaceuticals (Q.A/Q.C) and Group Companies (Torrel Cosmetics).
Analytical Development has the following capabilities::
- Analytical method development and their validation (for precision, accuracy, selectivity or specificity, linearity & range limit of detection, limit of quantization, ruggedness).
- Development / preparation of complete specifications for raw materials (Bulk drugs), finished products, intermediates, excepients, not mentioned in any pharmacopoeia
- Inclusion of in-house tests for strict control of pharmacopoeial materials and products
- Stability study of bulk drugs and formulations as per ICH guidelines under variety of conditions applicable
- Study of effect of solvent, alkalies, acids, excipients on the stability of bulk drugs and formulations
- Preformulations study of bulk drugs
- Routine services to various groups
- Kinetics and mechanism of degradation of bulk drugs and formulations
- Structure elucidation and characterisation of degradation products by UV, IR, Chromatography, DSC, Elemental analysis, Mass and NMR
- Characterization of polymorphs using differential scanning calorimetry and FT raman light scattering spectroscopy
- Analysis of active ingredient(s) and metabolite(s) from biological fluids for bioavailability / bioequivalence study
Analytical Development Laboratory has recently (August 2002) been accredited with the standard ISO/IEC 17025:1999 for its facilities by National Accreditation Board for Testing and Calibration Laboratories (NABL), an autonomous body under the aegis of Department of Science & Technology, Govt.of India.
NABL is a signatory to ILAC (International Laboratory Accreditation Cooperation) arrangements as well as APLAC (Asia Pacific Laboratory Accreditation Cooperation) Mutual Recognition Arrangements (MRA), is based on mutual evaluation and acceptance of other MRA partner laboratory accreditation systems.
Such International arrangements would facilitate acceptance of testing and calibration of Analytical Development Laboratory of Torrent R&D Center with countries to which are represented by MRA partners.
Analytical Development has provided necessary data for domestic and international registration of products. It has also given analytical support to Torrel Cosmetics and Torrent Gujarat Biotech Limited. Some of the important molecules are listed below:
- Amlodipine besylate
- Cerivastatin sodium
- Clopidogrel bisulfate
- Isosorbide mononitrate
- Losartan potassium
- Mosapride citrate
- Rosiglitazone maleate
- Sertraline hydrochloride
- Sibutramine hydrochloride monohydrate
- Sildenafil Citrate
- Sodium Stiboglyconate
- Valproic acid
- Venlafaxine hydrochloride
- Zolpidem hemitartrate
Methods Developed ::