We are committed to the highest standards of Environment, Health and Safety. We follow a very robust and systematic approach to ensure risk assessment and safety studies. We also evaluate alternative options to adopt safer processes throughout our research from development to manufacturing and safe handling of powders.
We offer process and powder safety assessment studies prior to manufacturing, irrespective of the phase of the molecule.
Safety Assessment using Literature and Database
- Review of the synthetic scheme for the potential hazards’ functionalities and gaseous by-products
- Assessing the hazardous nature of reagents or solvents used for the conversions by referring to the available data such as material safety data sheet (MSDS) and Brethrick's handbook of reactive chemical hazards. Review of the reaction parameters such as temperature and pressure
Safety Assessment : Screening Tests and Instruments
- Basic safety screening tests which include:
- Differential scanning calorimetry (DSC) for reaction masses, organic layers, mixtures, intermediates, etc.
- Thermal Screening Unit (TSU) studies
- Reaction Calorimetry (RC1mx)
- Accelerating Rate Calorimetry (ARC)
- Powder safety studies which include:
- Minimum ignition energy (MIE)
- Bulk powder resistivity test
- BAM Fall Hammer test
- Burning behavior
- Dust explosion
Why Aurigene Pharmaceutical Services?
Safety evaluation labs with infrastructure to support calorimetry, thermal screening and powder safety
Stringent SOPs for risk evaluation and stage wise risk assessment and safety reports
Assessed 500+ compounds
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Hyderabad R and D Center
Bangalore R and D Center
Resources
The importance of business continuity planning in CRDMO industry
Both natural and unnatural catastrophic events inflict negative consequences due to the ever-increasing interconnectedness of the global economy. Those consequences are certain to last for longer duration. e.g.; The Covid-19 pandemic is still having a negative impact on the global economy. Maintaining continuity is critical for all businesses, but perhaps no othe...
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Accelerating Drug Discovery Through Innovative Partnerships
Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....
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Physiochemical Characterization Services
Backed by our strong chemistry, we enable “Finger-print” protein structure and functional characterization for proteins from naked proteins to hyperglycosylated or derivatized proteins. ...
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Delivering 3 g dose of emetic and poorly bioavailable compound for 90 days repeated dose toxicity studies in dog
Background: Develop oral liquid dosage form of an IND candidate (small molecule) suitable for chronic toxicology studies in dogs. Must meet required systemic exposure and shall be dose proportional. Developed vehicle or used excipients shall be safe for chronic preclinical toxicology studies in dog. Challenges: Conventional suspension in dog resulted in low oral ...
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Construction of a quinoline ring via a 3-component reaction in water: crystal structure analysis and H-bonding patterns of a 2-aryl quinoline
2012
Montmorillonite K-10 mediated green and one-pot synthesis of 2-substituted quinolines has been accomplished via a 3-component reaction of aniline, aldehydes and ethyl 3,3- diethoxypropionate in the presence of air oxygen in water. The crystal structure analysis and H-bonding patterns of one compound prepared are presented. ...
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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets
2005
Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...
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A sensitive and a simple RP-HPLC method development and verification for the quantitative estimation of Cholecalciferol in tablets
2005
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis [1]. It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization [2]. IUPAC name of Cholecalciferol is (3β, 5Z, 7E) 9,10-secocholesta-5,7,10(19)-trien-3-ol, whose molecular weight is 384.64 g/mol and its molecular formula...
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A simple RP-HPLC method development and verification for the quantitative estimation of Sodium Butyrate in tablets
2005
Sodium butyrate is the sodium salt of butyric acid (Fig. 1), which exhibits various properties such as immune system modulator, antioxidant, and anti-inflammatory properties [1]. Furthermore, sodium butyrate is used as a promoter of growth in milk replacer formula for young calves [2]....
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