Infrastructure

  • Location that boasts of being on the Prime Location of Ahmedabad and easily approached by customers
  • Clean Room Paneling with Classified Area
  • All Instruments with 21 CFR complainant software
  • All Instruments on Uninterruptible Power Supply (UPS)
  • Fume hood for chemical usage6. Enterprise resource planning (ERP) for laboratory working with audit trail
  • Fire safety installed

Instrument

Most advanced technology is one of the key drivers of Global. All equipment are 21 CFR part 11 compliant and maintaining operational integrity.

  • High performance liquid chromatography (UHPLC - With PDA detector)
  • High performance liquid chromatography (HPLC - With PDA detector)
  • Gas Chromatography (With FID & TCD Detector)
  • GC Head Space (HS 20-Shimadzu make)
  • Inductively coupled plasma optical emission spectrometry (ICP OES)
  • Fourier transform infrared spectroscopy (With Diamond ATR)
  • Ultra violet- Visible spectroscopy (UV with 0.1cm-5cm Cuvettes facility)
  • Dissolution Appartus
  • pH Meter
  • Oven
  • Vacuum Oven
  • Muffle Furnace
  • Hot plate with stirrer
  • Karl-Fisher
  • Auto Titrator
  • Centrifuge
  • Water-bath
  • UV Cabinet
  • Refrigerator (with 2°- 8°C & -20°C)
  • UPS (15KVA with 45 min backup time)

Method Development as per ICH and USP guideline

  • Assay
  • Dissolution
  • Impurities / Organic impurities / Related Substances
  • Trace metals/Heavy Metals by ICP-OES
  • Residual solvents
  • Physico - Chemical tests

Method Validation as per ICH and USP guideline

The parameters evaluated for the method validation include:

  • Linearity
  • Limit of detection (LOD)
  • Limit of quantification (LOQ)
  • Specificity (including stability of solutions)
  • Precision (method, intermediate and system)
  • Accuracy (recoveries)
  • Robustness
  • Forced degradation
  • System Suitability
  • Specificity including forced degradation
  • Stability of solution
  • Filter compatibility
  • Linearity and range

The procedure followed for Analytical Method Validation :

  • Designing Method Validation Protocol
  • Getting approval
  • Initiating the analysis
  • Sharing Validation Report

API characterization and analysis

  • IR
  • NMR
  • Mass

Comparative Dissolution Study

Pending

Stability Studies

Stability Chambers for stability conditions continuously monitored by Automated Monitoring System with full back up power and water supplies.

  • Accelerated Stability Study : 40°C ± 2°C, 75% ± 5% RH
  • Intermediate Stability Study : 30°C ± 2°C, 65% ± 5% RH
  • Long Term Stability Study : 25°C ± 2°C, 60% ± 5% RH
  • Stability Study : 30°C ± 2°C, 75% ± 5% RH
  • Humidity cum Photo stability Study

Microbiological Analysis

  • Bacterial Endotoxin Test (LAL Test)
  • Microbial Assay of Antibiotics and Vitamins
  • Microsopical Examination / Crystallinity
  • Sterility
  • Test for Pathogens and Bacterial and Fungal Counts
Inquiry