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