LAXMAN BATHINI

Advantages
Its capacity for: Nondestructive testing
Analysis of final dosage form
Detection of Crystalline Impurities Detection of changes in morphology during

production

X-Ray Diffraction

Schematic Diagram

New Generation XRD system

Applications
Drug discovery: Determining whether a drug is

suitable as drug through HTS Drug Development:

o Phase Identification o Analyzing the of Effects of Processing on crystal form o Analyzing the Forensic Samples o Reverse Engineering of the Drug Products

o Quantitative Phase Analysis

Identify Counterfeit Medicines:

High throughput Screening

Polymorphic Forms

Different API Phases & Conc.

Effects of Processing
Monitoring of Crystallization Process
Monitoring Drying of Active Pharmaceutical Ingredient Monitoring the Influence of Milling of Active

Pharmaceutical Ingredient
Monitoring Wet Granulation Processes
Effects of Freeze Drying Processes

Monitoring Crystallization Process

Monitoring the Milling Process

Monitoring Tablet Pressure

Stability Studies
Nonambient Conditions X-ray Powder Diffraction o Phase transitions are directly monitored during analysis o temperature controlled XRPD (TC-XRPD)-Gives fruitful information in combination with Differential Scanning Calorimetry (DSC) on phase diagram of substance o humidity controlled XRPD (HC-XRPD)-Hydration or Dehydration processes are analyzed. By correlating Dynamic Vapor sorption (DVS) analysis and HC-XRPD weight changes are assigned to polymorphic phase trans.

Drug Regulation
PANalytical- Quick & Reliable screening of tablets

without removing blister packing. The typical measurement time for this technique takes between 10 and 30 minutes, depending upon thickness and properties of the tablets/capsules Scattering from the mainly amorphous polymer used for the blister material produces only a slightly increased background Aluminum lidding is evidenced by just two characteristic Bragg reflections at higher angles

Counterfeit Medicines

Blister with & without Al lidding

Blister with & without Tablet

Summary
Compatibility Studies
Control of ingredients- limit of detection 0.05% Crystallography and crystal structure determination Crystallintiy determination R&D application Phase analysis and polymorph screening Batch and dosage uniformity

References
Groen, H.; Mougin, P.; Thomas, A.; White, G.; Wilkinson,

D.; Hammond, R. B.; Lai, X.; Roberts, K. J. Ind. Eng. Chem.Res. 2003, 42, 4888. Cameron, M.; Zhou, G. X.; Hicks, M. B.; Antonucci, V.; Ge, Z.; Lieberman, D. R.; Lynch, J. E.; Shi, Y. J. J. Pharm.Biomed. Anal. 2002, 28, 137. Chan, H. K.; Doelker, E. Drug Dev. Ind. Pharm. 1985, 11,315. Otsuka, M.; Matsuda, Y. Drug Dev. Ind. Pharm. 1993, 19,2241.