Services


SDPARC offers precise, prompts, reliable and cost-effective analysis and research solutions in,

  • Pharmaceutical Analysis


  • Raw material testing
  • Intermediate testing
  • Finished product testing
  • Stability studies
  • Microbiology

  • Pharmaceutical Product development


  • Pharmaceutical Formulation Development.
  • Intermediate testing
  • Analytical Method development and Validation

  • Quality Assurance


  • Process optimization and SOP writing

Process optimization is a ongoing process, which can benefit industries in making the manufacturing more economic and less time consuming. SDPARC can intervene in to different process optimization activities and complete the requirements on a contractual basis.

Standard Operating Procedures for Laboratories and Manufacturing units can be developed in order to meet the requirement of regulatory authorities and to establish the GMP/GLP at different levels.



Analytical Research


Impurity analysis


Impurities are estimated using HPLC, Gas Chromatography, FT-IR and Atomic Absorption Spectroscopy.

Analytical method development and validation


Method development & validations for techniques like HPLC and Gas Chromatography. Validations for Related Substance, Assay, Residual Solvents, Dissolution profile, Trace Metals and Microbiological Tests.

Microbiology


Microbial limit tests and Sterility,
Microbial Assays
Validation of the methods
Sterility tests
BET studies
MIC studies
Microbiological pathology
Clinical microbiology

API, Intermediate and raw material analysis


NMR, Mass, FTIR, DSC, TGA XRD, Elemental Analysis, Chemical analysis, Stability studies

Ayurvedic product analysis


Raw material testing, Finished product testing, Assay, Metal analysis, Total ash, Disintegration of tablets, Water and alcohol soluble extracts, Identification by TLC

Preclinical studies


All studies are carried out according to ISO, OECD and GLP guidelines

CPCSEA Approval


SDPARC has registered itself with the Committee for the Purpose of Control and supervision of Experiments on Animals (CPCSEA) under the Ministry of Environment and Forests Government of India, vide 1743/PO/c/14/CPCSEA.

Toxicity studies


Abnormal toxicity
Acute toxicity
Sub acute toxicity
Eye and skin irritation studies
LD 50
NOAEL
Pyrogen tests

Bioassay


Human Chorionic Gonadotropins (hCG)
Menotropins (HMG)
Urofolitropin (FSH)
Corticotropin (ACTh)


Bio-compatibility


In vitro testing, Medical devices compatibility studies
Bio-efficacy studies, Pharmacological and pharmacokinetic studies

Research on animal based experiments is a strong domain of SDPARC. Various in vivo and isolated organ experiments can be performed at the centre. The parameters like IC50, EC50, and Cmax can be established in different efficacy studies.

Toxicity studies


Acute toxicity


Sub acute toxicity


SDPARC has established state of art acute and sub acute toxicity laboratory to evaluate LD50 value as well as oral/ parenteral/inhalation, Non Observed Adverse Effect Level (NOAEL). The centre has a separate team of qualified and dedicated scientists working on different animal experimentations. Further in vitro screening and enzyme inhibition studies have been thrust areas of research in CRO. In vitro screening for cytotoxicity is well established at our laboratory and has been used as a preliminary interpretation tool for NOAEL, antibacterial and anticancer agents.