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Integrated Discovery, Development  &

Regulatory Services

Drug Testing Lab

Regulatory testing and Pharmacopoeial analysis is one of the most important process of the pharmaceutical Industry. Bioneeds provides regulatory compliant and quality drug analysis reports by testing various parameters of drugs in our drug testing lab.

Bioassays:

Menotropin FSH activity

BP | USP

  • Test strain: Wistar / SD Rats
  • 3 Doses as per Pharmacopoeia
  • Paired ovaries Seminal vesicles weight determination
  • Statistical tests and Potency calculation

Urofoliotropin (Residual LH)

BP | EP

  • Test strain: Wistar / SD Rats
  • 3 Doses as per Pharmacopoeia
  • Ascorbic acid estimation
  • Statistical tests and Potency calculation

Epoetin alfa (Eryrthopoietin)

EP

  • Test strain: BALB/c mice
  • 3 Doses as per Pharmacopoeia
  • Reticulocyte count using Advia Analyzer
  • Statistical tests and potency calculation

Other Biological Tests as per BP / EP / USP / JP / IP

  • Abnormal Toxicity (Mice / Guinea pigs)
  • Pyrogen tests (Rabbits)
  • Test for Bacterial Endotoxins (commercial kits)
  • Sterility tests
  • Test for Microbial Contamination
  • Microbiological Assay of Antibiotics
  • Immunogenicity Tests (for HIV antigens, Hepatitis antigens etc)
  • Tests for vaccines
  • Efficacy of Antimicrobial Preservation
  • Test for Histamine
  • Blood and Blood related products

Physicochemical Tests

  • Identification by Chemical and UV Spectrophotometer
  • Determination of pH
  • Moisture Content Analysis (LOD)
  • Disintegration & Dissolution
  • Analytical Method Development & Validation
  • Microbiology Culture Preparation and Identifications
  • Stability Studies (Real time & Accelerated Stability Studies)
  • Color measurements & Identifications
  • Bulk density & Tap Density
  • Viscosity Measurements
  • Ash Value Determination
  • Weight Variation
  • Sieve Analysis
  • Related Substances
  • Content Uniformity
  • Refractive Index
  • Impurity Profile
  • Particle Size Evaluation
  • Assay
  • Distillation
  • Thickness
  • Limit Tests
  • Titrations
  • Melting point
  • Friability
  • Hardness

British | India | JP | Europ | US

Human Chorionic Gonadotropin (HCG)

USP | BP | IP

  • Test strain: Wistar / SD Rats
  • 3 Doses as per Pharmacopoeia
  • Uterus / Seminal vesicles weight
  • Statistical tests and Potency calculation

Urofoliotropin (FSH)

BP | EP

  • Test strain: Wistar / SD Rats
  • 3 Doses as per Pharmacopoeia
  • Paired ovaries weight determination
  • Statistical tests and potency calculation

Insulin

USP | BP | IP

  • Test strain: New Zealand White Rabbits
  • 2 Doses as per Pharmacopoeia
  • Plasma glucose measurement
  • Potency calculation

Services Portfolio

  • Physicochemical Analysis
  • Purity Determination
  • Stability Studies
  • Detection, Method Development and Validation
  • Analysis of Raw Materials, Finished Products and Related Substances

Stability Studies

  • Finished Product Stability
  • Stability at ambient temperature
  • Accelerated storage stability
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