Medicines

The Laboratory of Drugs, has a diverse and modern park of equipment, operating in a solid quality system and technical team with expertise in industrial processes, providing the best solutions for their products.

To know what services we are accredited, our detailed BPL (BPL 0021) can be found on the INMETRO website.

Services

Development and Studies with Medicines

  • Analysis of quality control of raw materials and finished pharmaceutical products
  • Development and validation of analytical methods and conventional stability indicating analytical methods (Stability Indicating Methods)
  • Dissolution profile ready to solid oral dosage forms release and modified
  • Study of pharmaceutical equivalence
  • Study of bioavailability / bioequivalence pharmaceutical (analytical phase)
  • Study of accelerated stability and long-lasting
  • Study photostability
  • Characterization and isolation of impurities and degradation products present in raw materials and finished products

Main physico-chemical testing in pharmaceutical dosage forms

  • Analysis of vitamins and minerals
  • Analysis for process validation
  • Analysis for Cleaning Validation
  • Description ( Appearance )
  • Determination of pH
  • Determination of density by pycnometer
  • Determination of soil moisture by Karl Fisher
  • Determination of moisture gravimetrically
  • Determination of temperature and melting range
  • Determination of sulfated ash ( residue on ignition )
  • Determination of particle size of powders
  • Determination of total ash
  • Determination of acid insoluble ash
  • Identification by the technique of thin layer chromatography
  • Uniformity in unit dose
  • Determination of hardness tablets with or without coating
  • Determination of friability
  • Determination of weight in dosage forms
  • Determination of volume dosage forms
  • Determination of disintegration time for tablets and capsules
  • Determination of the dissolution time for tablets and capsules
  • Determination of purity by chromatography
  • Determination of potentiometry and voltammetry
  • Identification and quantification by spectrophotometry ultraviolet and visible
  • Identification and quantification by infrared spectroscopy
  • Assay by titration
  • Determination of the content , impurities and identified by liquid chromatography
  • Determination of the content , impurities and identified by gas chromatography
  • Limit test for iron
  • Limit test for ammonia
  • Limit test for arsenic
  • Limit test for sulphates
  • Limit test for chlorides
  • Limit test for heavy metals
  • Rotary Viscosity
  • Capillary Viscosity
  • Fatty acids by gas phase chromatography
  • Acidity and alkalinity
  • Solution Clarity
  • Determination of metals by atomic absorption spectrophotometry with flame ( FAAS )
  • Determination of metals using an ICP / MS
  • Determination of particle size

Toxicological tests

  • Primary Skin Irritation
  • Eye irritation test in rabbits
  • Systemic Injection Test

Microbiological tests

  • Counting of viable microorganisms in products that need not comply with the sterility test
  • General method for screening and identifying pathogens
  • Microbiological assay of antibiotics
  • Determination of vitamin B12 activity - Microbiological Methods - turbidimetric
  • Sterility Testing (Challenge Test)
    • Pseudomonas aeruginosa
    • Staphylococcus aureus
    • Escherichia coli
    • Aspergillus niger
    • Candida albicans

Forced degradation studies on drugs (RCD 53 of 2015)

  • Analytical Development
  • Compatibility Study
  • Isolation and structural characterization by NMR
  • Structural elucidation
  • Analytical Standards
  • Toxicology Studies

Accreditations

Structure

  • LC/MS/MS – API 5500 Qtrap
  • LC/MS/MS - API 5000
  • LC/MS/MS - API 4000 Qtrap
  • LC/MS/MS – API 3200 Qtrap
  • GC / MS MS – Triplo quadrupolo
  • GC - MS7 – Ion Trap
  • GC – MSD
  • GC - FPD
  • GC - µECD
  • GC / FID