Innovators of l · 2014-11-12 · stek AnalyticalServicessM continued from page 1. Expertise: -...

Innovators ofl ***e~~~o~*e*~~~a**ee*~**~‘

High Resolution: Chromatography

”..-.- _..-. ___) . . . . . . _*)” . . . . . . ...” ._...._.^. - ..-(l-... “I..(),~^ . . . “._ll___l_~___l...~_)_cGMP, HPLC, and GC method development 1and validation 1

..” . ..- . ---.- . . . . . . . . . . . . _. _- . . . . ..--.-..-............ “.... . .._ . . -_-.--.. *Stationary phase development *

*___ _^............, _j_i//‘...(lx . . . . . . ~.~..--..- . . . . ““.. i i-i..._L.(-_(... _-_ . . . . . . . ~___jaFull lines of HPLC and GC columns and 1accessories_~ .._.__” ..,.... o_Lll‘_/i(( . . ..i_ _I_*^__~._~~~ji~.j/.~~...“~.~~_-..” 1Innovative hardware and accessory designs 1

““_._ _” _.__ -.-~_l__...- ._.. ~...“_...“._~.__I___ . .._ ~ ._... _“~~~~___..Unsurpassed HPLC and GC technical support 1

“‘~yLL__l_l~_.~-“.i~..=.~~~~-~~~~~.”.--..~~~~HPLC and GC educational services *

~-_.“~“l_-..._ _ -...._ I__ ..__ ~...*_.cI_~.I_x_---~.~.~_~~_ 6

Restek Corporation is proud to :announce the grand opening of jRestekAnalytical ServicesSM *(RAS). RAS is a unique and 1innovative, current GoodManufacturing Practices ’(cGMP)-compliant chromatog- 1raphy laboratory, designed to -deliver quality products and 1services for the pharmaceutical smarket. No other column /

manufacturer can provide such 1complete services to support =their products. Along with a 1full line of both HPLC and GC .’columns, RAS offers analytical ^method development and 1validation, HPLC/GC educa- *tion and training, customstationary phase design, and ucGMP/regulatory services and 1support.

RAS has assembled seasoned 1researchers and analysts who e

*

have extensive experience in 1cGMP method development aand validation. These experts ’are a perfect complement to our :existing manufacturing staff. *As a group, we understand the 1pressures and time constraints 1associated with pharmaceutical *research and have practical 1experience analyzing many of Ithe common drugs currently 1under development. The entire GRAS staff is dedicated to *helping you achieve your goals :in a timely and compliant nfashion.

In addition to offering acomplete selection of qualityHPLC and GC columns, wecan help design tools to fit yourunique requirements. Wecontinue to develop newstationary phases and applica-tions in response to customer

by David Bliesner 1u in this issue

inquiries and needs. We candesign a product and servicepackage specially for you.

For further information, pleaserequest the RAS fulfillmentfolder (cat.# 59630). Thisfolder includes details onquality assurance, research anddevelopment, analyticaldevelopment and validation,laboratory and regulatoryservice, and HPLC columnsand accessories.

Or, feel free to contact thedirector of the RAS laboratory,Dr. David Bliesner, to discussyour specific applications. Hecan be reached at 800-356-1688 or 814-353-1300, ext.2193. Call us today and findout why RAS is truly the futureof chromatography.

Restek Analytical Services. ..pg. 1

Chiral Separation ofUnderivitized

Pharmaceuticals. ..pg. 3

Azo Dye Analysis. . . pg. 4

Tribute to Dr. Kovatspgs.5&11

New Rt-U PLOT Columns. ..pg.6

OrganoTin Mixes. ..pg.7

Why ShouldYou use Rtx@-CLPesticides Columns?

. ..pg. 8

SilcosteeP-TreatedInjection Ports

. ..pg. 9

Ultra-Clean XAD@-2 Resin. . . Pg. 9

Rtx@‘-624 Column forAnalysis of Rum 81 Scotch

. ..pg. 10

Koni’s Korner. ..pg. 12

Peak Performers. ..pg. 14

News From Restek. ..pg. 16

;P,

stek Analytical ServicessMcontinued from page 1.

Expertise:- HPLC method development -

and validation in a cGMP ”environment

-Qualification and operation .of cGMP analytical Ilaboratories

-Thin layer chromatography 1- cGMP auditing and data .

review- 15 years combined R&D and 1

leadership experience *dbliesner@restekcorp.com 1

Expertise:- HPLC method development

and validation in a cGMPenvironment

-Thin layer chromatography- 8 years of experiencedbell@restekcorp.com

Expertise:- HPLC bonded phase

synthesis- Synthetic chemistry- HPLC method development_ 16 years of experiencekeithd@restekcorp.com

Expertise: *

- HPLC column packing :- HPLC column bonding j_ 16 years of experience 1larryp@restekcorp.com _

Expertise:- R&D and HPLC packing

materials and hardwareproduction

- 9 years of experiencerrome@restekcorp.com

*..* ..*.* ..*.

Development &Validationl HPLC and GC method development and validationl Ruggedness testingl Robustness testingl HPLC column crossover validationl Method troubleshooting and optimizing

Laboratory & Regulatory Servicesl HPLC & GC Educational Servicesl Assistance in preparation with CMC

sections for NDAs. Laboratory auditing servicesl On-site data review and troubleshootingl Pre-approval inspection (PAI) preparation assistance

Research & Developmentl Developing custom stationary phasesl Designing new hardware and accessoriesl Investigating new separation technologiesl Improving existing products

Quality Assurancel Full compliance with cGMPsl QA testing is an integrated part of the RAS system

HPLC Columns & Accessoriesl Pinnacle@, Hypersil@, Inertsilo, Kromasila,

and Nucleosil@ HPLC columnsl Unsurpassed technical supportl Quality HPLC accessoriesl 30-day “no questions asked” return policyl Stationary phase and hardware design

.

1 “In the modern chromatography

I laboratory, you want one thing- reliable solutions to yourchromatographic problems.

Previously, when a methodcould not be reproduced,

questions such as, ‘Is it thecolumn or did something

. change in the sample workup?’, could not be answered by one

’ source. By combining productdevelopment and method

development under one: umbrella, you can be assured

that your problem will beo solved with full accountability.

1 Any method validation done by* Restek is supported by a teamY

of dedicated scientists with1 your success in mind. RAS is a: fully cGMP compliant labora-

. tory that provides personalizedservices dependent on your

1 needs. We can provide training,

method development andvalidation, or custom design

. stationary phases to speed upyour analysis or achieve a

il difficult separation. Please givej us a call and let us help you.“

David M. Bliesner, Ph.D.

Director, RASSM

Reste kAnalytical

Services-