In a case where a detector is positioned in a [11-20] direction, and where a first measurement region including a center of a main surface is irradiated with an X ray in a direction within ±15° relative to a [−1-120] direction, a ratio of a maximum intensity of a first intensity profile is more than or equal to 1500. In a case where the detector is positioned in a direction parallel to a [−1100] direction, and where the first measurement region is irradiated with an X ray in a direction within ±6° relative to a [1-100] direction, a ratio of a maximum intensity of a second intensity profile is more than or equal to 1500. An absolute value of a difference between maximum value and minimum value of energy at which the first intensity profile indicates a maximum value is less than or equal to 0.06 keV.

In a case where a detector is positioned in a [11-20] direction, and where a first measurement region including a center of a main surface is irradiated with an X ray in a direction within ±15° relative to a [−1-120] direction, a ratio of a maximum intensity of a first intensity profile is more than or equal to 1500. In a case where the detector is positioned in a direction parallel to a [−1100] direction, and where the first measurement region is irradiated with an X ray in a direction within ±6° relative to a [1-100] direction, a ratio of a maximum intensity of a second intensity profile is more than or equal to 1500. An absolute value of a difference between maximum value and minimum value of energy at which the first intensity profile indicates a maximum value is less than or equal to 0.06 keV.

An X-ray system includes, first and second X-ray channels (XCs), a spot sizer and a processor. The first XC is configured to: (i) direct a first X-ray beam for producing a spot on a surface of a sample, and (ii) produce a first signal responsively to a first X-ray radiation received from the surface. The spot sizer is positioned at a distance from the surface and is shaped and positioned to set the spot size by passing to the surface a portion of the first X-ray beam. The second XC is configured to: (i) direct a second X-ray beam to the surface, and (ii) produce a second signal responsively to a second X-ray radiation received from the surface, and the processor is configured to: (i) perform an analysis of the sample based on the first signal, and (ii) estimate the size of the spot based on the second signal.

An X-ray system includes, first and second X-ray channels (XCs), a spot sizer and a processor. The first XC is configured to: (i) direct a first X-ray beam for producing a spot on a surface of a sample, and (ii) produce a first signal responsively to a first X-ray radiation received from the surface. The spot sizer is positioned at a distance from the surface and is shaped and positioned to set the spot size by passing to the surface a portion of the first X-ray beam. The second XC is configured to: (i) direct a second X-ray beam to the surface, and (ii) produce a second signal responsively to a second X-ray radiation received from the surface, and the processor is configured to: (i) perform an analysis of the sample based on the first signal, and (ii) estimate the size of the spot based on the second signal.

A valence of a target element of a sample and crystallinity of a sample can be detected with a small device. The analysis device 100 includes: a placement holder 110 for placing a sample S; an X-ray source 11 for irradiating the sample S with X-rays; a first detector 141 for detecting characteristic X-rays generated from the sample S by the irradiation of the X-rays; a second detector 142 for detecting X-rays diffracted by the sample; and a signal processing device 20. The signal processing device 20 detects the valence of the target element of the sample based on the characteristic X-rays detected by the first detector 141, and detects the crystallographic data of the sample based on the X-rays detected by the second detector 142.

A sample inspection system and a corresponding method for inspecting a sample is provided. The sample inspection system includes a beam former, a beam modulator an energy resolving detector and a collimator. The beam former is adapted to receive an electromagnetic radiation from an electromagnetic source to generate a primary beam of electromagnetic radiation. The beam modulator is provided at a distance from the beam former to define a sample chamber. The collimator is provided between the beam modulator and the energy resolving detector. The collimator has a plurality of channels adapted to receive diffracted or scattered radiation. Upon incidence of the primary beam onto the beam modulator, the beam modulator provides a reference beam of diffracted or scattered radiation. The energy resolving detector is arranged to detect the reference beam.

A sample inspection system and a corresponding method for inspecting a sample is provided. The sample inspection system includes a beam former, a beam modulator an energy resolving detector and a collimator. The beam former is adapted to receive an electromagnetic radiation from an electromagnetic source to generate a primary beam of electromagnetic radiation. The beam modulator is provided at a distance from the beam former to define a sample chamber. The collimator is provided between the beam modulator and the energy resolving detector. The collimator has a plurality of channels adapted to receive diffracted or scattered radiation. Upon incidence of the primary beam onto the beam modulator, the beam modulator provides a reference beam of diffracted or scattered radiation. The energy resolving detector is arranged to detect the reference beam.

The present disclosure introduces methods for characterizing iron core carbohydrate colloid drug products, such as iron sucrose drug products. Disclosed methods enable the characterization of the iron core size of the iron core nanoparticles in iron carbohydrates as they exist in the formulation in solution, such as e.g. iron sucrose drug products, and more particularly, the average particle diameter size and size distribution(s) of the iron core nanoparticles. The disclosed methods apply small-angle X-ray scattering (SAXS) in parallel beam transmission geometry, with a sample mounted inside a capillary and centered in the X-ray beam, to iron carbohydrates, such as iron sucrose, in solution without the need to modify the sample, such as to remove unbound carbohydrates, dilute, or dry the sample, to accurately characterize the average iron core particle diameter size of the iron core nanoparticles. An example application of the disclosed method is to perform SAXS measurements under identical instrument settings on two samples of the same type of iron core nanoparticle colloid drug product for the purpose of comparing their iron core structures. Such comparisons are typically performed during the iron core carbohydrate colloid drug development process, and can include comparisons of samples that have been manipulated.

The present disclosure introduces methods for characterizing iron core carbohydrate colloid drug products, such as iron sucrose drug products. Disclosed methods enable the characterization of the iron core size of the iron core nanoparticles in iron carbohydrates as they exist in the formulation in solution, such as e.g. iron sucrose drug products, and more particularly, the average particle diameter size and size distribution(s) of the iron core nanoparticles. The disclosed methods apply small-angle X-ray scattering (SAXS) in parallel beam transmission geometry, with a sample mounted inside a capillary and centered in the X-ray beam, to iron carbohydrates, such as iron sucrose, in solution without the need to modify the sample, such as to remove unbound carbohydrates, dilute, or dry the sample, to accurately characterize the average iron core particle diameter size of the iron core nanoparticles. An example application of the disclosed method is to perform SAXS measurements under identical instrument settings on two samples of the same type of iron core nanoparticle colloid drug product for the purpose of comparing their iron core structures. Such comparisons are typically performed during the iron core carbohydrate colloid drug development process, and can include comparisons of samples that have been manipulated.

An X-ray scattering apparatus having a sample holder for aligning and/or orienting a sample to be analyzed by X-ray scattering, a first X-ray beam delivery system having a first X-ray source and a first monochromator being arranged upstream of the sample holder for generating and directing a first X-ray beam along a beam path, a distal X-ray detector arranged downstream of the sample holder and being movable, in a motorized way, is disclosed. The first X-ray beam delivery system is configured to focus the first X-ray beam onto a focal spot near the distal X-ray detector when placed at its largest distance from the sample holder or produce a parallel beam so that the X-ray scattering apparatus has a second X-ray beam delivery system having a second X-ray source and being configured to generate and direct a divergent second X-ray beam towards the sample holder for X-ray imaging.