Importance Of Crystallization

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1. INTRODUCTION

Crystallization is an essential technique in pharmaceutical manufacturing since most of the active pharmaceutical ingredients (API) are available in a solid form1. It plays an important role in marketing, manufacturing, and including interaction with excipients in the crystalline state2.
The physical properties of the active pharmaceutical ingredients such as crystalline form, morphology and particle size distribution will strongly affect the solubility and bioavailability of a solid dosage form (Table 1) 3.
The process of crystallization, especially crystallization from solution, is used as a separation and purification technique and in the production of pharmaceutical solid forms3,4. Knowledge of the crystal structure allows the crystal engineer to know and manipulate the chemistry of the crystal in order to optimize exact characteristics performance 3.
Furthermore chemical and physical properties of a material are dictated by crystallization process. The crystal properties such as: particle size, shape, surface characteristics, purity and defect structure, as well as thermodynamic and mechanical properties3 will be affected even by minor changes in crystallization conditions5.

1.1 Crystal
A crystal is defined as a solid form that contains a very high degree of internal three-dimensional order of the components atoms, molecules and ions2. The crystal structure of atoms and molecules has a unique arrangement, which leads to the regular repeat of interatomic distances within the material4.
The shape of a crystal is a reflection of its inner, atomic-scale structure. The faces of a crystal are labelled with respect to the crystal axes. Each face has a set of three integers (h, k, l), which are known as Mill...

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...ed to provide sufficient data to determine the unit cell and crystal system30-35. Once the optimum data collection is automatically calculated by the control system, a complete set of images is recorded, which will provide the full data set required for the structure determination35.

4.2 X-ray Powder Diffraction

Powder diffraction is used for the identification of unknown materials. For a powder, the spots seen in single-crystal patterns are smeared into powder rings. In X-ray powder diffraction, there is no need to move the sample in the powder diffractometer, because for every Bragg crystal plane, some crystallites statistically will be orientated correctly34.
All necessary information that requires identifying a phase through comparison with a database of patterns from known materials is provided when a single radial scan is showed35.

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