Amorphous Content Determination

Crystalline substances are generally less than 100% crystalline. The crystallization process itself may already produce some amorphous solids, and subsequent processing steps (such as melt quenching, freezing and spray drying, grinding, wet granulation and so on) may destroy the original crystal structure and cause chaos. Amorphous impurities have very different physicochemical properties than when they are in a crystalline state. It makes the solid form of the drug no longer well defined, its storage stability will be reduced, and the aggregation behavior of the powder may change. Therefore, the detection, quantification, characterization and management of amorphous components play a central role in ensuring process control during the development and manufacturing stages. The commonly used methods of amorphous content determinations include X-ray powder diffraction, differential scanning calorimetry, dynamic vapor sorption and so on.

 Quantitation of the amorphous content with thermal methods.Fig.1 Quantitation of the amorphous content with thermal methods.

CD Formulation laboratories can test products of any scale, and we can provide comprehensive amorphous content determination for APIs according to related standards. Our scientists will help you to make a decision for operational and procedural conditions that can ensure the physical and chemical stability and pharmacological activity of the product to minimize potential formulation and stability issues.

Our Methods for Amorphous Content Determination

Method Advantages Limitations Limit of Detection
X-ray Powder Diffraction (XRPD) Nondestructive
Fast
Specific
Universally applicable
Requires internal referencing; no absolute values
Low sensitivity
Adverse effect on accuracy by crystal size and orientation possible
10%
Differential Scanning Calorimetry (DSC) Fast
Specific
Only small amount of substance required
Uncritical kinetics
Limited to temperature-stable substances
Low sensitivity
10%
Dynamic Vapor Sorption (DVS) Sensitivity can be high
Simple sample preparation
Relatively simple method setup
Depends on hygroscopicity of the amorphous material and its tendency to recrystallize <1%
Microcalorimetry (μCal) High sensitivity
Simple sample preparation
Requires suitable crystallization kinetics <1%
Solution Calorimetry (SolCal) High sensitivity Requires rapid dissolution <1%

Our Advantages

Amorphous Content Determination

How to Contact Us?

If you have a requirement about amorphous content determination services, please contact us by phone or email, our colleagues will reply to you within three working days.

References

  1. Savolainen M, Jouppila K, Pajamo O, et al. Determination of Amorphous Content in the Pharmaceutical Process Environment[J]. Journal of Pharmacy and Pharmacology, 2007, 59(2): 161-170.
  2. Yu L. Amorphous Pharmaceutical Solids: Preparation, Characterization and Stabilization[J]. Advanced Drug Delivery Reviews, 2001, 48(1): 27-42.

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Please note: Our products and services can only be used for research purposes. Do not use in diagnostic or therapeutic procedures!
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