We aim at providing pharmaceutical stability solutions that include the study of product-related factors that influence the quality of a drug, such as the:
Interaction of an API with excipients Container closure systems Packaging materials but also the proneness to oxidation and hydrolysis
All stability samples are stored under controlled conditions such as incubators and stability chambers for accelerated/long-term/intermediate stability studies. The suitability of a drug substance or a drug product for its intended use is defined by attributes such as identity, strength, and purity.
Thermal stability
In general, the drug substance and drug product are evaluated under storage conditions (with appropriate tolerances) that test their thermal stability and, if applicable, their sensitivity to moisture. The storage conditions and the lengths of studies are defined by regulatory guidelines such as ICH, but we also offer customized programs.
Possible conditions include
Drug Substances:
- Long term: 25°C ± 2°C/60% RH ± 5% RH or 5°C ± 3°C
- Accelerated: 40°C ± 2°C/75% RH ± 5% RH
Drug Product:
- Long term: 25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/75% RH ± 5% RH
- Intermediate: 30°C ± 2°C/65% RH ± 5% RH
- Accelerated: 40°C ± 2°C/75% RH ± 5% RH
Photostability
The intrinsic photostability characteristics of a new drug substance or drug product are assessed to demonstrate that light exposure does not result in unacceptable change. Usually, we conduct photostability testing for a single batch of the material selected as described under the selection of batches in the parent guideline. Under some circumstances, these studies can be repeated if certain variations and changes are made to the product (such as formulation and packaging). The repeat study helps us understand photostability characteristics determined at the time of initial filing and the type of variation and/or change made.
A systematic approach to photostability testing is recommended, based on studies such as:
- Tests on the drug substance
- Tests on the exposed drug product outside of the immediate pack, and if necessary
- Tests on the drug product in the immediate pack, and if necessary
- Tests on the drug product in the marketing pack
In-use stability
Our in-use stability testing services help to establish the period during which a multi-dose product can be used while retaining quality within an accepted specification once the container is opened. The continued integrity of products in multi-dose containers after the first opening is an important quality issue.
Why Aurigene Pharmaceutical Services?
State-of-the-art infrastructure
Capability to perform various forms of stability testing
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
Methoxy Polyethylene Glycol (m-PEGs)
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Base mediated spirocyclization of quinazoline: one-step synthesis of spiro-isoindolinone dihydroquinazolinones
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A novel approach for the spiro-isoindolinone dihydroquinazolinones has been demonstrated from 2- aminobenzamide and 2-cyanomethyl benzoate in the presence of KHMDS as a base to get moderate yields. The reaction has been screened in various bases followed by solvents and a gram scale reaction has also been executed under the given conditions. Based on the controll...
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2005
An improved and rapid synthesis of mefenamic acid based indole derivatives has been achieved via the ligand free Cu-catalyzed coupling-cyclization method under ultrasound irradiation. This simple, straightforward and inexpensive one-pot method involved the reaction of a terminal alkyne derived from mefenamic acid with 2- iodosulfanilides in the presence of CuI ...
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Formal synthesis of Cladospolide C & epi-Cladospolide C using R- (þ)-g-valerolactone as a chiral synthon
2005
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A new one pot multicomponent annulation strategy for the synthesis of various dihydroquinazolinone compounds has been developed using Amberlite-15 as a catalyst, giving good to moderate yields. In this reaction the substrate scope for amines and aldehydes was also investigated. The reaction has been checked on a large scale ...
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