Events

Samina Hussain out of our Sante Fe Springs lab will be a distinguished guest speaker for the upcoming IPA conference on Analysis of Metal Impurities According to Proposed USP Chapters.

Ms. Samina Hussain
Senior Chemist/Metals Group Leader
Health Sciences
Exova

Samina Hussain has over 15 years of experience specifically on testing various samples by ICP and ICPMS. She has prepared and analyzed literally hundreds of different matrices for metals testing using various sample preparation procedures including microwave, high-pressure asher, mixed acid, and hydrofluoric acid. Her breadth of experience includes work in the pharmaceutical, supplement, cosmetic, environmental, industrial hygiene, and various other industries. She also has extensive experience with method development and method validation. Ms Hussain is in charge of the metals testing group at the California Exova laboratory which includes 6 ICPMSs, 2 ICPs. XRF, and CV/AF. The ICPMSs are also coupled with LCs and GCs for speciation analysis as well as other specialized analyses. ICPMS coupled with laser ablation is another technique offered. Her staff includes several Ph.D.s who are experts in their fields.

Her main interest is to help implement a rational and scientifically defensible method to determine the amount of heavy metals in pharmaceutical/supplement raw materials and finished goods. With her tremendous amount of experience with both the wet chemistry methods, as found under USP <231>, as well as testing for heavy metals by ICPMS, ICP, XRF, CV/AF, ICPMS/LC she has become a leader in this area. The volume of samples as well as the vast range of sample types/matrices has made it clear to Ms Hussain how important the sample preparation, as well as, choosing the appropriate instrument for analysis is to the quality of the data. To quote her, “I want to make sure that my knowledge, as well as my colleague's knowledge, is brought to bear on this very important subject”.

ABOUT THE COURSE:
The United States Pharmacopoeia, USP has significantly changed the way in which metal analysis is conducted in drugs and dietary supplements. In January 2010 USP proposed three new chapters on elemental impurities (<232>, <2232>, and <233>) with new requirements for limits and recommendations for metal analysis in drugs and dietary ingredients.

The final version is expected to be released in late 2010, and by 2013 the current chapter <231> will be obsolete.

This course will cover instrumentation, method development and method validation for analyses of elemental impurities in pharmaceutical materials currently being tested using USP Chapter Heavy Metals <231>. The course will be taught in light of the elements and limits proposed in the draft chapter <232> Elemental Impurities, with an emphasis on ICP and ICP-MS analyses consistent with USP general chapter Plasma Spectrochemistry <730> and the default methodology proposed in draft chapter <233> Elemental Impurities - Procedures.