Research

Analytical Method Development

Various analytical methods for formulations, raw materials, API's and intermediates have been developed at SDPARC. Instrumental methods developed include, Proguanil Hydrochloride, Forskolin, Guggulsterone, Many dissolutions methods have been developed and validated at the centre. Methods for estimating residual solvents and organic volatile impurities are also developed and validated at the centre.

Impurity Profile

Impurity profiling, method developments and validation of methods developed for impurities are the other regular activities of SDPARC. Impurity identification by GC followed by the validation of method developed as per ICH guidelines is carried out on regular basis.

  • Organic Impurities
  • Residual Solvents
  • Inorganic Impurities

Forced degradation Studies

SDPARC designs & performs forced degradation studies of pharmaceutical products.

Validation of analytical methods

SDPARC designs the analytical method validation protocols depending on the regulatory body to which the submission is to be made. Our team of experts has developed many methods like residual solvent analysis by GC, analysis of related substance by HPLC and GC, assay method validation, etc.

Dossier

Development of Dossiers, based on customer requirement of the customers is regularely done at SDPARC. Dossiers shall be developed based on the registering countries. The analytical, Stability, Toxicity and Validation work assosciated with Dossiers are performed inhouse.

DMF

Drug Master Files based on european common Technical Document (e-CTD) are developed at SDPARC. The Characterisation, Validation and Stability studies are performed in house. SDPARC has experience to developed both restricted and applicant part of DMF like cetrizine dihydrochloride, mebendazole, albendazole, metoclopramide hydrochloride, Nalidixic acid, Furesamide etc.

Structure Characterization

Structure Characterization is the essential part of Drug Master File, SDPARC has well experienced scientist having good knowledge of structure elucidation.