Method Development & Validation

PolyCrystalLine offers a wide range of analytical services which includes cgmp quality control. Its provide a full complement of state-of-the-art gmp analytical testing resources and expertise to support cgmp quality control testing for raw materials, active pharmaceutical ingredients (api) and intermediat...

PolyCrystalLine offers a wide range of solid form screening which includes co-crystals screening. It is an molecular crystals in which at least one of the compounds is an active pharmaceutical ingredient (api). Salts are considered different from co-crystals provided that its crystals formed by ionic multi...

Api and impurities

PolyCrystalLine offers a wide range of Pre-formulation studies which includes Dissolution testing. It is a Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution or solubilisation of the drug under physiological...

PolyCrystalLine offers a wide range of Pre-formulation studies which includes In vitro bioequivalence studies. It is considered as a surrogate for clinical evaluation of the therapeutic equivalence of drug products based on the fundamental bioequivalence assumption that when two drug products are equivalen...

Kilo Lab, available for HPAPI, narcotic or controlled substances, pressure reactions

PolyCrystalLine offers a wide range of analytical services which includes physical characterization. Its an physicochemical properties of a compound is essential so that the formulation process can be rational and streamlined. Contact us for more information.

PolyCrystalLine offers a wide range of solid form screening which includes polymorph screening. In an early stage of drug development helps to avoid manufacturing problems, to fine-tune the performance of drugs and provides space for innovations. Contact us for more information.

API route scouting, up to kilo-Lab

PolyCrystalLine offers a wide range of solid form screening which includes salts screening. It is one of the primary solid-state approaches used to modify the physical properties of apis, a major limitation within this approach is that the api must possess a suitable (basic or acidic) ionisable site. Conta...

PolyCrystalLine offers a wide range of solid form screening which includes solvates/hydrates identification. It is an amorphous and crystalline forms, a solid drug may be anhydrous or a solvate/hydrate. When a solid form contains a solvent, it is known as a solvate. Contact us for more information.

PolyCrystalLine offers a wide range of Pre-formulation studies which includes Stability studies. Its thermodynamic relationships between polymorphic forms is crucial and must be established carefully, because as drug crystallises from different conditions the kinetically favoured metastable polymorph appea...