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 Identification and prevention of degradation pathways in product Container closure systems
All stability samples are stored under controlled conditions such as incubators and stability chambers for accelerated or long-term or 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.
Conditions
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
- Tests on the drug product in the immediate pack
- 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
Other Services
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Drug Formulation Services
Resources
-
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, ...
Read More -
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...
Read More -
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]....
Read More
You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.
If you wish to continue to this external website, click Proceed.
Leaving already?
Don't forget to join us at
CPHI Worldwide 2023.
October 24th-26th, 2023 | Barcelona, Spain
Get ready to accelerate your drug’s journey to the market