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Integrated Discovery, Development  &

Regulatory Services

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:

BP | USP

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

USP | BP | IP

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

BP | EP

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

BP | EP

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

EP

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

USP | BP | IP

  • Test strain: New Zealand White Rabbits
  • 2 Doses as per Pharmacopoeia
  • Plasma glucose measurement
  • Potency calculation
  • 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 Analysis
  • Purity Determination
  • Stability Studies
  • Detection, Method Development and Validation
  • Analysis of Raw Materials, Finished Products and Related Substances
  • Finished Product Stability
  • Stability at ambient temperature
  • Accelerated storage stability
  • Testing of finished goods for certification of drug release as per USP, IP, BP, EP and customer specifications
  • Method development and validation of new drugs (ICP-MS / AAS / OES, IC, LCMS, GCMS, HPLC, UV spectrophotometer and FTIR)
  • Dissolution test and disintegration studies of tablets and herbal drugs
  • Active content analysis, Assay, impurity profile analysis by HPLC, GC etc
  • Organic Volatile Residual solvent, Trace elemental analysis, Disinfectant by products analysis
  • Stability studies of new drug as per ICH guidelines
  • Extractables and Leachables analysis
  • Physico-chemical test
  • Microbiogical Analysis, Biochemical confirmatory tests for pathogens etc.,
  • Acute Toxicity Oral, Dermal, Ocular, Inhalation
  • Repeat-Dose Toxicity Studies (Sub-acute /Subchronic / Chronic
  • Genetic Toxicity
  • Local Tolerance / Skin sensitization
  • Abnormal Toxicity
  • Pyrogen tests and Tests for Bacterial Endotoxins
  • Eco-toxicology
  • Efficacy Models
  • Histamine Tests
  • Method Development & Validation using HPLC / GC
  • Determination of Purity using validated method
  • Raw Materials

Identification, Assays, Limit test, Heavy metals, Related substances, Sterility, Total Microbial count and Pathogen detection.

  • Tablets

Average weight, Weight Variations, Identification, Friability, Physical dimensions, Thickness, Hardness, Disintegration, Dissolution, Active Ingredient Analysis, Uniformity of Content, Sterility, Total Microbial count and Pathogen detection.

  • Capsules

Average weight, Identification, Disintegration, Dissolution, Active Ingredient Analysis, Uniformity of Content Sterility, Total Microbial count and Pathogen detection.

  • Liquid formulations

Specific gravity, Identification, Fill volume check, Viscosity, Active Ingredient Analysis, Sterility, Total Microbial count and Pathogen detection.

  • Injectable

Sterility test.

  • 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

Drug Testing Lab

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