Innovators of l · 2014-11-12 · stek AnalyticalServicessM continued from page 1. Expertise: -...
18
Innovators of l ***e~~~o~*e*~~~a**ee*~**~‘ High Resolution : Chromatography ” ..-.- _..-. ___) . . . . . . _*)” . . . . . . ...” ._...._.^. - ..-(l-... “I..(),~^ . . . “._ll___l_~___l...~_)_ cGMP, HPLC, and GC method development 1 and validation 1 ..” . ..- . ---.- . . . . . . . . . . . . _. _- . . . . ..--.-..-............ “.... . .._ . . -_-.--.. * Stationary phase development * * ___ _^............, _j_i//‘...(lx . . . . . . ~.~..--..- . . . . ““.. i i-i..._L.(-_(... _-_ . . . . . . . ~___ja Full lines of HPLC and GC columns and 1 accessories _~ .._.__” ..,.... o_Lll‘_/i(( . . ..i_ _I_*^__~._~~~ji~.j/.~~...“~.~~_-..” 1 Innovative 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 j RestekAnalytical ServicesSM * (RAS). RAS is a unique and 1 innovative, current Good Manufacturing Practices ’ (cGMP)-compliant chromatog- 1 raphy laboratory, designed to - deliver quality products and 1 services for the pharmaceutical s market. No other column / manufacturer can provide such 1 complete services to support = their products. Along with a 1 full line of both HPLC and GC .’ columns, RAS offers analytical ^ method development and 1 validation, HPLC/GC educa- * tion and training, custom stationary phase design, and u cGMP/regulatory services and 1 support. RAS has assembled seasoned 1 researchers and analysts who e * have extensive experience in 1 cGMP method development a and validation. These experts ’ are a perfect complement to our : existing manufacturing staff. * As a group, we understand the 1 pressures and time constraints 1 associated with pharmaceutical * research and have practical 1 experience analyzing many of I the common drugs currently 1 under development. The entire G RAS staff is dedicated to * helping you achieve your goals : in a timely and compliant n fashion. In addition to offering a complete selection of quality HPLC and GC columns, we can help design tools to fit your unique requirements. We continue to develop new stationary phases and applica- tions in response to customer by David Bliesner 1 u in this issue inquiries and needs. We can design a product and service package specially for you. For further information, please request the RAS fulfillment folder (cat.# 59630). This folder includes details on quality assurance, research and development, analytical development and validation, laboratory and regulatory service, and HPLC columns and accessories. Or, feel free to contact the director of the RAS laboratory, Dr. David Bliesner, to discuss your specific applications. He can be reached at 800-356- 1688 or 814-353-1300, ext. 2193. Call us today and find out why RAS is truly the future of chromatography. Restek Analytical Services . ..pg. 1 Chiral Separation of Underivitized Pharmaceuticals . ..pg. 3 Azo Dye Analysis . . . pg. 4 Tribute to Dr. Kovats pgs.5&11 New Rt-U PLOT Columns . ..pg.6 OrganoTin Mixes . ..pg.7 Why ShouldYou use Rtx@- CLPesticides Columns? . ..pg. 8 SilcosteeP-Treated Injection Ports . ..pg. 9 Ultra-Clean XAD@-2 Resin . . . Pg. 9 Rtx@‘-624 Column for Analysis of Rum 81 Scotch . ..pg. 10 Koni’s Korner . ..pg. 12 Peak Performers . ..pg. 14 News From Restek . ..pg. 16 ;P,
Transcript of 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 *[email protected] 1
Expertise:- HPLC method development
and validation in a cGMPenvironment
-Thin layer chromatography- 8 years of [email protected]
Expertise:- HPLC bonded phase
synthesis- Synthetic chemistry- HPLC method development_ 16 years of [email protected]
Expertise: *
- HPLC column packing :- HPLC column bonding j_ 16 years of experience [email protected] _
Expertise:- R&D and HPLC packing
materials and hardwareproduction
- 9 years of [email protected]
*..* ..*.* ..*.
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-
