FDA GMP Drug Substance X-Ray Diffraction
Project Description
MULTIPLE PRODUCTS
FDA GMP Pharmaceutical Laboratory needed to perform X-ray diffraction for our drug substances, Finasteride and Tadalafil. The analysis results will be used for ANDA application so the method need to be validated and the experiment needs to be perform under GMP regulation.
Finasteride:
System: D-8 Focus or equivalent.
Make: Bruker AXS
X- Ray Tube: Copper Ka, 2A
Counter: Lynx Eye
Kß filter:Nickel (Ni)
Voltage: 40 Kv
Current: 35mA
Wavelength: 1.5406 A
2Theta start: 2
2Theta end: 50
Scan speed: 0.2 sec/stepIncrement: 0.02
Scan type-Locked-coupled: Continuous
Rotation: 30rpm
Divergence slit: 0.3
Tadalafil:
X-ray Cu, ka, Ka1 (Å): 1.540598; Ka2 (Å): 1.544426;
The intensity of Ka2/Ka1: 0.50
Configuration Reflection-transmission spinner
Revolution time 1s
Scan Axis Gonio
Scanning mode continuous
Scanning range 3°-40° or 3°-60°
Step size (°) 0.0131
Incident beam path Soller slits: 0.04rad
Divergence slit: 1/8°
Bean mask: 10mm
Anti-scatter slit: 1/4°
Diffracted beam path Fliter : Large beta-filter Nickel/Actual
Soller slit: Large Soller slits 0.04 rad
Anti-scatter slit: 7.5mm
Detector: PIXcel1D-Medipix3 detector
Mode: Scanning
Active length: 3.3473°
Generator Tension: 45KV; Current: 40mA
Project Information
Number:22-01484
Industry:Pharmaceuticals