Drug Testing Laboratory
Regulatory testing & pharmacopoeia 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.
Menotropin FSH Activity
BP | USP
- Test strain: Wistar/SD Rats
- 3 doses as per pharmacopoeia
- Paired ovaries seminal vesicles weight determination
- Statistical tests & potency calculation
Human Chorionic Gonadotropin (HCG) Test
USP | BP | IP
- Test strain: Wistar/SD Rats
- 3 doses as per pharmacopoeia
- Uterus/seminal vesicles weight
- Statistical tests & Potency calculation
Urofollitropin (Residual LH)
BP | EP
- Test strain: Wistar/SD Rats
- 3 doses as per pharmacopoeia
- Ascorbic acid estimation
- Statistical tests & potency calculation
Urofollitropin (FSH)
BP | EP
- Test strain: Wistar/SD Rats
- 3 doses as per pharmacopoeia
- Paired ovaries weight determination
- Statistical tests & potency calculation
Epoetin alfa (Erythropoietin)
EP
- Test strain: BALB/c mice
- 3 doses as per pharmacopoeia
- Reticulocyte count using advia analyser
- Statistical tests & potency calculation
Insulin
USP | BP | IP
- Test strain: New Zealand White Rabbits
- 2 Doses as per pharmacopoeia
- Plasma glucose measurement
- 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 & blood related products
Services Portfolio
- Physicochemical analysis
- Purity determination
- Stability studies
- Detection, method development & validation
- Analysis of raw materials, finished products & related substances
Stability Studies
- Finished product stability
- Stability at ambient temperature
- Accelerated storage stability
Physicochemical Test
British | India | JP | Europe | US
- Identification by chemical & UV spectrophotometer
- Determination of pH
- Moisture content analysis (LOD)
- Disintegration & dissolution
- Analytical method development & validation
- Microbiology culture preparation & 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
Analytical Methods
- Determination of AI content
- Validation of analytical method
- Analysis of five batches
Skin Irritation/ Corrosion
- Spectral data (MS, NMR, IR, UV /Vis)
- Melting point/ freezing, boiling point
- Relative density
- Vapor pressure
- Solubility in water and organic solvents
- Auto/self-ignition temperature
- Partition coefficient n-octanol
- Flash point
- Explosive properties
- Flammability
- Surface tension
- Granulometry
- Oxidizing properties
- Dissociation constant
- Viscosity &
- Others
Toxicological Studies
Acute Toxicity
- Acute oral toxicity
- Acute dermal toxicity
- Acute inhalation toxicity
Skin Irritation/ Corrosion
- In vitro human skin model test
- In vitro membrane barrier test method for skin corrosion
- In vitro transcutaneous electrical resistance test
- In vitro reconstructed human epidermis test method
- Acute toxicity: skin irritation/ corrosion
Eye Irritation/ Corrosion
- In vitro bovine corneal opacity and permeability test
- In vitro isolated chicken eye test method
- Acute toxicity: irritation / corrosion
Skin Sensitisation
- Guinea pig maximisation test
- Skin sensitisation – Local Lymph Node Assay
Eye Irritation/ Corrosion
- In vitro bovine corneal opacity and permeability test
- In vitro isolated chicken eye test method
- Acute toxicity: irritation / corrosion
Phototoxicity
- In vitro 3T3 NRU phototoxicity test
Repeated Dose Toxicity
- Repeated dose 28/90 -day oral toxicity studies
- Repeated dose dermal toxicity: 21/28-day studies
- Dermal toxicity: 28/ 90-day study
- Inhalation toxicity: 28/90 day studies
Long Term Toxicity and Carcinogenicity
- Chronic toxicity test
- Carcinogenicity studies
- Combined chronic toxicity/ carcinogenicity study
Genotoxicity Study
- Bacterial reverse mutation test
- In vitro mammalian cell micronucleus test
- In vitro mammalian cell chromosome aberration test
- In vitro gene mutation assay mammalian cells
- In vitro comet assay
- In vivo micronucleus erythrocyte assay in mammals
- Mammalian erythrocyte micronucleus test
- Mammalian bone marrow chro¬mosome aberration test
Reproduction & Generational Studies
- Pre-existing developmental toxicity study
- One and two generation reproduction toxicity
- Extended one-generation reproduction toxicity
Ecotoxicology Studies
- Acute toxicity for fish
- Acute immobilisation & Reproduction test-Daphnia
- Growth inhibition Test –Algae & Lemna sp.
- Acute oral, dietary, sub-chronic and reproductive toxicity to birds
- Honeybees, acute oral & contact toxicity
- Activated sludge, respiration inhibition
- Earthworm reproduction test
- Collembolan reproduction test in soil
- Predatory mite (hypoaspis (geolaelaps) aculeifer) reproduction test
- Seedling emergence & seedling growth test
- Vegetative vigour test
- and others…
Fate & Behaviour in the Environment
- Hydrolysis as a function of pH
- Adsorption-desorption
- Biodegradability test
Endocrine Disruptor studies
- Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists
- H295R Steroidogenesis Assay
- Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals
- Uterotrophic Bioassay in Rodents
- Hershberger Bioassay in Rats
- Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Male and Female RatsRats