- Solubility studies in different media (organic, aqueous and different PH levels).
- Characterization of the thermal profile and identification of polymorphic forms by DSC.
- Impurities profile characterization.
- Raw material standardization.
- Forced degradation studies ("stress testing") of active substances.
- Development of analytical methods for the API (richness, degradation products and residual solvents).
- Assay method, uniformity of content and preservatives (by spectrophotometry, chromatography and potentiometry).
- Related substances method (liquid, gas or ion chromatography).
- Water content determination method; residual solvent method.
|Categories||Contract Services - Analytical & Lab ServicesMethod Development; Contract Services - Analytical & Lab ServicesMethod Validation; Contract Services - Analytical & Lab Services|
More products from Idifarma Des. Farmaceutico. S.L.
Contract Development Services
At Idifarma we are specialists in the
comprehensive management of pharmaceutical development projects. We carry out
all the experimental, documentation and consulting work, from finding a
supplier of active substance to the elaboration of the registration dossier of
a pharmaceutical product.
Idifarma offers solutions in different dosage
forms with the ultimate goal of optimizing its future industrial production.
The formulation development services encompasses:
- Selection of dosage form.
- API and excipient compatibility studies.
- Definition of qualitative and quantitative form...
Idifarma’s GMP plant is authorized for the
manufacturing of solid oral dosage forms of both non-potent and highly potent
drugs (cytostatic, cytotoxic, hormonal, hormone inhibitors) for clinical and
commercial use. Also we can manufacture placebo for clinical trials.
This authorization allows u...
Low solubility and low bioavailability problems are more and more frequent today in pharmaceutical development projects, and that is why Idifarma invested in Spray Drying as a suitable technological solution.
We have a complete Spray Drying suite comprised of a lab-scale Buchi B290 and a&...
With our experimented analytical staff with a
broadly equipped laboratory we can analyze products of different
pharmaceutical finished dosage forms developed or GMP manufactured by us. We
have an in-house microbiology laboratory.
Idifarma can perform:
- ICH stability studies (in controlled temperature and humidity conditions according to ICH – climatic zones I to IV).
- Photostability studies to evaluate the resistance to light radiation.
- Studies of stability in use to determine periods of use in multidose or reconst...
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