Toxicology:
We at Krish Biotech Research has more than 12 years of experience in GLP complaint toxicity studies (safety assessment studies). We can perform the studies in compliance with global regulatory guidelines such as ICH, FDA, EMA, EU, OECD, OPPTS, JMAFF, CIB etc. We can also support you with tailor made studies as per specific requirement from various regulatory bodies.
Below are the list of toxicity studies performed at Krish Biotech Research:
6 Pack Acute Studies
- Acute Oral Toxicity
- Acute Dermal Toxicity
- Acute Inhalation Toxicity
- Skin Irritation
- Eye Irritation
- Skin Sensitization/ LLNA
Repeat Dose Studies
- Sub-acute, Sub-chronic & Chronic
- Repeated Dose Inhalation
- Carcinogenicity
- Combined Chronic / Carcinogenicity
- CNS safety
- Acute / Delayed Neurotoxicity
Developmental & Reproduction
- Pre-Natal Developmental
- Two Generation Reproduction
- Reproduction Developmental Screen
- Combined Repeated Dose Toxicity Study with Reproduction/ Developmental Toxicity Screening Test
- Male Fertility
- Extended One-Generation Reproductive Toxicity Study
Genetic Toxicology
In vivo & In Vitro Assays
- Bacterial Reverse Mutation Test (AMES)
- In vivo Mammalian Erythrocyte Micronucleus Test
- In vitro Mammalian Chromosome Aberration Test
- In vivo Chromosomal Aberration Assay in Bone Marrow Cells
- In vitro Mammalian Cell Gene Mutation test using the Hprt and Xprt locus
- In vitro Mammalian Cell Micronucleus Test
- In vitro Mouse Lymphoma Assay
Ecotoxicology
Terrestrial and Aquatic
- Growth Inhibition Test Algae and Lemna
- Acute Immobilization – Daphnia
- Fish Toxicity Test (Carp, Trout, Zebra etc.)
- Honeybees Toxicity (Oral and Contact)
- Earthworm Acute & Reproduction Toxicity
- Avian Oral & Dietary Toxicity Test
- Silk Worm Toxicity test
- Toxicity to Soil Microorganism and activated sludge
- Nitrogen Transformation
- Carbon Transformation
Analytical:
Our team at KBRPL is well endowed with modern facilities and instruments which use updated technologies for the identification and quantification of TGAI formulated products, impurities and degradation products. The analytical team is competent in handling various complicated techniques like chromatographic and spectroscopic etc. We cater to various industries depending upon the requirement and product type. Our methods are fully developed and validated.
Some of the major instruments include:
1. HPLC
2. LC-MS/MS
3. GC-MS/MS
4. Ion Chromatograph
5. Differential Scanning Calorimeter
6. Thermogravimetric Analyzers
7. UV-VIS Spectrophotometer
8. Ultra Performance Liquid Chromatograph
9. ICP-MS
10. Infrared Spectrophotometer
Herbals, Nutraceuticals & Cosmetics-
The trained team at KBRPL is well equipped to work on several invitro studies which imply those studies which are performed outside of a living organism. There are several types of studies performed here.
Keeping in mind the changing regulatory requirements, we are also developing and validating various invitro studies.
- In-vitro Skin Corrosion – RhE Test method
- In-vitro Skin Irritation – RhE Test Method
- In-vitro Eye Irritation/Serious Eye Damage Test
- In-vitro 3T3 NRU Phototoxicity Test
Bioanalytical:
Bioanalytical team of Krish Biotech specializes in quantitative and qualitative aspects of the same. We can support you with method development, method validation and study sample analysis. We deal with several studies in the bioanalytical domain including Bioanalysis in Plasma samples. We provide services for routine compounds in discovery, and in preclinical (toxicology) and clinical development.
Under Bioanalytical Method Development and Validation, we are constantly developing and validating methods for both small molecules and biologics across many technology platforms including Tandem LC/MS/MS (Ion Trap & TQD, GC-MS/MS (TQD) and ligand binding assays with ELISA systems.
Histopathology:
We have a well-trained team of veterinary pathologist and also technicians. Our services include necropsy, clinical pathology, histopathology and histology services. We work on a wid range of clinical pathology services namely:
- Hematology, clinical chemistry coagulation, APTT (Activated partial thromboplastin time) and Urinalysis
- Microscopy including bone marrow analysis
- Specialized services for assessing neurotoxicity
- Screening for bacterial and viral pathogens using molecular biology techniques like ELISA
- Necropsy and histology involving routine and specialized tissue collection
In addition to this, the pathology department possesses the requisite advanced automated instruments necessary for getting histology slides, tissue processors, strainers and microtomes.
Chemistry:
We have a great team of specialized and ably trained chemistry professionals and scientists working on five batch analysis, physical chemistry, residue studies and Drug Metabolism and Pharmo-kinetic studies. We work on:
Physical chemical parameters testing
| Study Type | SANCO | OECD | CIPAC | OPPTS/OCCPS | EC/EU | ASTM | ISO |
| Active Ingredient Analysis : Method validation | 3030 | NA | NA | NA | NA | NA | NA |
| UV Spectral Analysis | NA | 101 | NA | 830.705 | NA | NA | NA |
| Melting point TGAI/API | NA | 102 | MT 2 | 830.72 | A.1 | NA | NA |
| Boiling point TGAI/API | NA | 103 | 830.722 | A.2 | NA | NA | |
| Vapour pressure (GS) | NA | 104 | NA | 830.795 | A.4 | NA | NA |
| Vapour pressure (TGA) | NA | NA | |||||
| Surface Tension | NA | 115 | NA | NA | A.5 | NA | NA |
| Viscocity | NA | 114 | MT 192 | NA | NA | NA | NA |
| NA | MT 22 | NA | |||||
| pH | NA | 122 | MT 75.3 | 830.7000 | NA | NA | NA |
| Physical State | NA | NA | NA | 830.6303 | NA | NA | NA |
| Color | NA | NA | NA | 830.6302 | NA | ASTM D-1535 | NA |
| Odor | NA | NA | NA | 830.6304 | NA | NA | NA |
| Loss on Drying | NA | NA | MT 17 | NA | NA | NA | NA |
| Accelerated Storage Stability-14 Day | NA | 113 | MT 46.3 | 830.6317 | NA | NA | NA |
| Metal and Metal Ions | NA | NA | NA | 830.6313 | NA | NA | NA |
| Explodability | NA | NA | NA | 830.6316 | A.14 | NA | NA |
| Flash point | NA | NA | MT 12 | NA | A.9 | NA | NA |
| Flamability | NA | NA | NA | 830.6315 | A.10 | NA | NA |
| Oxidation and Reduction | NA | NA | NA | 830.6314 | NA | NA | NA |
| Oxidising Properties | NA | NA | NA | NA | A.17 | NA | NA |
| Corrosion Charecteristics | NA | NA | NA | 830.6320 | NA | NA | NA |
| Acidity, Alkalinity | NA | 122 | MT 31, 191 | NA | NA | NA | NA |
| Dry Sieve test | NA | NA | MT 170 | NA | NA | NA | NA |
| Pour and Tap Density | NA | NA | 186 | 830.7300 | NA | NA | NA |
| Dustiness | NA | NA | MT 171.1 | NA | NA | NA | NA |
| Attririon Resistance | NA | NA | MT 178.2 | NA | NA | NA | NA |
| Wet Sieve | NA | NA | MT 185 | NA | NA | NA | NA |
| Suspensibility | NA | NA | MT 184 | NA | NA | NA | NA |
| Persistent Foam | NA | NA | MT 47.1 | NA | NA | NA | NA |
| Dispersibility | NA | NA | MT 174 | NA | NA | NA | NA |
| Stability at low tempertaure | NA | NA | MT 39.3 | NA | NA | NA | NA |
| Pourability | NA | NA | MT 148.1 | NA | NA | NA | NA |
| Spontaneity of Dispersion | NA | NA | MT 160 | NA | NA | NA | NA |
| Emulsion Stability and re emulsification | NA | NA | MT 36.3 | NA | NA | NA | NA |
| UV | NA | 101 | NA | 830.7050 | NA | NA | NA |
| Melting Point | NA | 102 | NA | 830.7200 | A.1 | NA | NA |
| Boiling Point | NA | 103 | MT 2 | 830.7220 | A.2 | NA | NA |
| Vapour Pressure (GS) | NA | 104 | NA | 830.7900 | A.4 | NA | NA |
| Vapour Pressure (TGA) | NA | 104 | NA | 830.7900 | A.4 | NA | NA |
| Water Solubility-Shake Flask Method and column elution | NA | 105 | MT 157 | 830.7840 | A.6 | NA | NA |
| Density Solid Pyknometer | NA | 109 | MT 3 | 830.7300 | A.3 | NA | NA |
| Density Oscillating Densitometer (Liquids) | NA | 109 | MT 3 | 830.7300 | NA | NA | NA |
| Active Ingredient and Method Validation | 3030, rev. 5 | NA | NA | NA | NA | NA | NA |
| Method Development | NA | NA | NA | NA | NA | NA | NA |
| Partition Coeffient by shake Flask Method | NA | 107 | NA | 830.7550 | A.8 | NA | NA |
| Partition Coeffient by HPLC | NA | 117 | NA | 830.7570 | A.8 | NA | NA |
| Dissociation constant UV-Visible | NA | 112 | NA | 830.7370 | NA | NA | NA |
| Dissociation constant Titrimetry | NA | 112 | NA | 830.7370 | NA | NA | NA |
| Hydrolysis as function of pH | NA | 111 | NA | 835.2130 | NA | NA | NA |
| Carbon Transformation | NA | 216 | NA | NA | NA | NA | NA |
| Nitrogen Transformation | NA | 217 | NA | NA | NA | NA | NA |
| Degradion in water | 825 | 101 | NA | NA | NA | NA | NA |
| Degradion in soil | 825 | NA | NA | NA | NA | NA | |
| Five Batch Analysis | NA | NA | NA | NA | NA | NA | NA |
| Method Validation of residue study | SANCO/825/00 | OECD 504, 506 | NA | OPPTS 860.1340 | NA | NA | NA |
| Carbon-Nitrogen Transformation Test | NA | OECD 216, 217 & Bureau of Indian Standard | NA | NA | NA | NA | NA |
| Partition Co-efficient | NA | OECD 107, EEC A.8, OECD 117 | NA | OPPTS 830.7550 | NA | NA | NA |
| Accelerated Storage Stability | NA | NA | CIPAC MT 46.3 | OPPTS 830.6320 | NA | NA | NA |
| Metal & Metal Ion | NA | NA | NA | OPPTS 830.6313 | NA | NA | NA |
| Method Development & Validation | SANCO 3030 & SANCO 3029 | NA | NA | NA | NA | NA | NA |
| Five Batch Analysis | NA | Relevant guideline | NA | NA | NA | NA | NA |
| Extraction of Medical Device | NA | NA | NA | NA | NA | NA | ISO 10993:12 |
| Micibility_Liquids only | NA | NA | 23 | 830.6319 | NA | NA | NA |
| Organc solvent solubility | NA | NA | CIPAC MT 181 | NA | NA | NA | NA |
| Wettabilty | NA | NA | 53.3 | NA | NA | NA | NA |
| Corrosivity | NA | NA | NA | NA | G31-72 | NA | |
| Flowability | NA | NA | MT 172.2 | NA | NA | NA | NA |
| Moisture content | NA | NA | 30.6 | NA | NA | NA | NA |
| Volatility | NA | NA | 56 | NA | NA | NA | NA |
| Freeze & thaw | NA | NA | NA | NA | NA | NA | NA |
| Dilution stability | NA | NA | 41.1 | NA | NA | NA | NA |
| Shelf life | NA | NA | NA | NA | NA | NA | NA |
| Container content compatibility | NA | NA | NA | NA | NA | NA | NA |
| Acetone insolubility | NA | NA | 27 | NA | NA | NA | NA |
| Dossolution degree & solution stability | NA | NA | 179 | NA | NA | NA | NA |
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