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Determination of Crystallinity by Near Infrared (NIR) Spectroscopy (CAT#: STEM-ST-1505-CJ)

Introduction

The degree of crystallinity or amorphism in pharmaceutical materials is recognized as a critical factor that may affect drug stability and dosage form performance. Consequently, it is important to monitor the extent of crystallinity during bulk material scale‐up, formulation development, manufacturing, and over the intended shelf‐life of a pharmaceutical product.




Principle

Near-infrared spectroscopy (NIRS) is a method that uses light between the visible and infrared wavelength ranges (approximately 800 – 2500 nm) and measures the absorption of light as a function of wavelength. The near-infrared light that interacts with the sample has specific wavelengths that are absorbed based on certain chemical bonds (e.g. C-H, O-H, S-H, and N-H) being present in the sample.

Applications

Biomedical; Biopharmaceuticals

Procedure

1. Prepare samples.
2. Place the sample in the Near Infrared Spectroscopy.
2. Analyze data and identify samples.

Materials

• Sample: Molecules with C-H, O-H, S-H, and/or N-H bonds (Such as: Proteins, Peptide, Water, Alcohol, Fats, Oils, Hydrocarbons); Volatile Organics; Moisture; Fatty Acids; Solids; Carbohydrate; Liquids, Pastes; Tablets; Capsules, etc.
• Equipment: Near Infrared (NIR) Spectroscopy

Notes

1. NIR is non-destructive, and requires little or no sample preparation.
2. NIR reflectance spectra can be used to quickly determine a material’s properties without altering the sample.
3. NIR can depending on wavelength penetrate up to 20 mm of a sample which makes NIR more effective for solid samples.
4. FTIR spectroscopy is, in principle, very similar to Near Infrared (NIR) spectroscopy, but works at longer wavelengths where the chemical information from the samples is more specific.
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