Study Set Content:
ability of a particular formulation in a specific container to remain within its pysical, chemical, therapeutic and toxicological specifications
Stability of Pharmaceutical Product
Different factors such as temperature, humidity and even light intensity can affect the quality of a pharmaceutical product
Shelf-life determination
conducted to show long a pharmaceutical product can be stored at normal or accelerated conditions without any degradation to its properties
Stability testing studies
This is the storing of pharmaceutical products and materials up to their point of use.
Storage
- Different products require different storage conditions. Instability lab, storage conditions and changes in the substances are recorded.
Storage condition recommendation
- Some products, such as certain vaccines, need to be transported within a cold chain and stored at -20°C (4°F)
Store frozen
Some products are very heat sensitive but must not be frozen.
Store at 2°-8°C (36°-46°F):
Store between 8°-15°C (45°-59°F).
Keep cool
- Store at 15°-25°C (59°-77°F).
Store at room temperature:
- Store at the surrounding temperature. This term is not widely used due to significant variation in ambient temperatures.
Store at ambient temperature:
Stability Considerations of Dosage forms:
- Factors that affect products stability:
- Temperature
- Light
- PH-level
- Humidity
- gravity
- agitation
- inversion
- method and nature of manufacture
- moisture
- science of obtaining, processing, and communicating information about the composition and structure of matter
ANALYTICAL CHEMISTRY
- art and science of determining what matter is and how much of it exists
ANALYTICAL CHEMISTRY
is an analysis done to determine:
1. The presence of a substance and the amount of that substance.
2. The biological or pharmacological potency of a drug.
ASSAY
ASSAY is an analysis done to determine:
1. The presence of a substance and the amount of that substance.
2. The biological or pharmacological potency of a drug.
determination of non-numerical information about a chemical species, a reaction
Qualitative analysis
Determination of how much a given component is present in a sample
Quantitative Analysis
Quantitative methods analysis classification:
1. Based on sample size
2. Base on extent of determination
3. Based on nature of the analytical method
refers to either proximate analysis or ultimate analysis
Extent of Determination
determines the total amount of a class or group of active components in a given test sample
Proximate analysis
