API and Drug Product Stability Testing
Welcome to our API and drug product stability testing services!
Stability testing of Active Pharmaceutical Ingredients (APIs) and pharmaceuticals is an important aspect of drug development and manufacturing. Protheragen-ING provides high-quality stability testing services. This test service mainly examines the law of API or drug preparations under the influence of temperature, humidity, and light. It provides a scientific basis for its production, packaging, storage, and transportation conditions, and the validity period of drugs is established through experiments.
API Stability Testing
This test usually involves the stability study under different environmental conditions, to understand the factors affecting its stability and possible degradation pathways and degradation products, and to provide a scientific basis for the production process, packaging, and storage conditions of the preparation and the establishment of analytical methods for degradation products.
The test items offered are listed below:
(i) Impact factor test
Sample requirement 1 batch. The sample is placed in an open container and spread into a thin layer of ≤5mm thickness for testing. If necessary, we conduct qualitative or quantitative analysis of degradation products.
| High-temperature test |
10 days at 60℃. |
| High humidity test |
10 days at 25℃ under 90%±5% relative humidity respectively. |
| Strong light exposure test |
The opening is placed in a light box equipped with fluorescent lamps or other suitable light devices, and left under an illumination of 4500lx ± 500lx for 10 days. |
Protheragen-ING can be used to design tests according to the nature of the drug to investigate the effects of pH oxygen and other conditions on drug stability.
(ii) Accelerated test
Samples are required in batches of 3 and left for 6 months at a temperature of 40±2 ℃and a relative humidity of 75±5%.
For APIs that are particularly sensitive to temperature, the test can be conducted at a temperature of 25±2 ℃ and a relative humidity of 60±10% for 6 months.
(iii) Long-term test
Test material 3 batches, at a temperature of 25±2 ℃, relative humidity 60±10% of the conditions placed in 12 months, or at a temperature of 30±2 ℃, relative humidity 65±5% of the conditions placed in 12 months. 12 months later, still need to continue to examine the provisions of the development of the expiration date in the low-temperature storage conditions.
APIs that are particularly sensitive to temperature can be placed at a temperature of 6±2 ℃ for 12 months and tested as required.
Pharmaceutical Stability Testing
This test involves evaluating the physical, chemical and microbiological properties of a finished dosage form (e.g. tablets, capsules, injections, or creams) over time under different environmental conditions.
The test items offered are listed below:
(i) Influence factor test
The purpose is to examine the rationality of the formulation prescription with the production process and packaging conditions.
Samples were carried out in 1 batch. After removing the outer packaging, the samples were placed in suitable open containers and subjected to high-temperature tests, high-humidity tests, and strong light irradiation tests. Test conditions, methods, sampling time, and API are the same.
(ii) Accelerated test
Sample requirements for 3 batches. Test conditions, methods, and sampling time are the same as API.
Emulsions, suspensions, ointments, creams, pastes, gels, ophthalmic ointments, suppositories, aerosols, effervescent tablets, and effervescent particles should be used directly at a temperature of 30±2 ℃, with a relative humidity of 65±5% of the conditions for the test, and other requirements and the same as above.
For pharmaceutical preparations packed in semi-permeable containers, such as infusion bags prepared with low-density polyethylene, plastic ampoules, ophthalmic containers, etc., the test shall be carried out at a temperature of 40±2 ℃ and a relative humidity of 25±5% (CH3COOK·1.5H2O saturated solution).
(iii) Long-term test
Sample requirements for 3 batches. Test conditions, methods, and sampling time are the same as API.
For pharmaceutical preparations packed in semi-permeable containers, the test is conducted at a temperature of 25±2 ℃ and relative humidity of 40±5%, or 30±2 ℃ and relative humidity of 35±5%.
If you are interested in this service and need more information, contact us and we will arrange for professionals to provide you with more information and discuss your specific requirements.
