SERVICES

Global Analytical Laboratory has a wide range of analytical services for testing of raw materials, bulk drugs, final products, Water and Chemicals.

Chemical Analysis

  • Assay by Titration
  • Conductivity
  • Disintegration
  • Limit test in RMs involving quantitative analysis
  • Loss on Drying
  • Melting Point
  • Nitrogen Determination
  • Particulate Matter by Visual Inspection
  • pH
  • Quantitative estimation / Analysis other than Assay
  • Refractive Index
  • Specific Optical Rotation
  • Sulphated Ash / Residue on Ignition
  • Uniformity of Dosage Unit
  • Viscosity / K-Value (Low volume also available)
  • Water by Karl Fisher
  • Weight Variation
  • Specific Gravity
  • Weight per mL

Instrument Analysis

  • Analysis on UPLC
  • Analysis using by TLC
  • Analysis using by GC and GC – HS
  • Analysis on Ultra-Violet Spectrophotometer
  • Content Uniformity by UV, HPLC, ICP-OES
  • Dissolution by UV and HPLC
  • Elemental Analysis and Heavy metals by ICP-OES
  • HPLC analysis using DAD, RI and UV Detector
  • Infrared Spectrophotometer (FTIR / ATR)
  • Organic Volatile Impurities / Residual Solvent by GC Head Space

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

Global analytical Laboratory is adept in conducting significant dissolution profiling studies for the generic pharmaceutical industry. The studies effectively help the clients with identification of formulation factors that influence bioavailability of the API and gauge quality assurance and bioequivalence.

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