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Usage of IC in the bio/pharma industry Currently Use Not Sure Do Not Use 68 % 18 % 14 % Ultraviolet (UV/Vis) Conductivity Pulsed Amperometric Detection (PAD) Mass Spectrometry (MS) Fluorescence Evaporative Light Scattering Detection (ELSD) Charged Aerosol Detection (CAD) Inductively Coupled Plasma-MS (ICP-MS) High Resolution MS (HRMS) Not Sure 38 % 38 % 33 % 27 % 22 % 11 % 9 % 8 % 8 % 6 % 11 % How do the bio/pharma industry use compendial monographs? Use them as a minimum standard and stating point Follow them word for word Refer to the methods but don’t follow them Planning to use them Do not use them Not Sure Use them as a minimum standard and stating point Follow them word for word Refer to the methods but don’t follow them Planning to use them Do not use them Not Sure Are the bio/pharma industry familar with USP General Chapter <1065> ion Chromatography? Yes No 18 % 32 % 31 % 10 % 6 % 3 % 44 % 56 % Modernizing pharmacopeial monographs with IC Anions and Cations in a Drug Formulation Anions and Cations in a Drug Formulation Current Monograph Scenario TOTAL # OF TESTS INVOLVED = 5 TOTAL # OF TESTS INVOLVED = 2 With the USP Modernization Initiative Sodium Potassium Magnesium Chloride Acetate Gluconate Phosphate Cationic IC Cationic IC Cationic IC Anionic IC Anionic IC Anionic IC Anionic IC Flame photometry Flame photometry Atomic absorption Titration with silver nitrate Ion Exclusion Chromatography Ion Exclusion Chromatography Spectroscopic Procedure More on Drug Monographs and Assays Using Ion Chromatography thermofisher.com/PharmaIC Panel Discussion on Pharmacopeial Monograph Modernization and Ion Chromatography Register & Watch On-Demand Now ©2017 Thermo Fisher Scientific. All rights reserved. ST72591-EN 1217S Application of Ion Chromatography in the Bio/Pharma Industry In August-September 2017 an online survey was conducted by the Analytical Scientist (a Texere Publication) on behalf of Thermo Fisher Scientific. The intent was to learn more about the application of ion chromatography (IC) in the bio/pharmaceutical industry and the level of awareness and applicability of pharmacopeial monograph modernization. The qualified responses collected in the survey are the basis for the data shared in this infographic. APIs/Drug Substances.. Counterions ... of API or Drug Sustance Impurities/degradants... Excipients and inactive formulation components Monosaccharides and sialic acids Amino acids (in biologics drugs) Antibiotics Glycans (in biologics drugs) Other (small molecules...) Not Sure 49 % 48 % 32 % 25 % 19 % 15 % 13 % 8 % 8 % 8 % What do the bio/pharma industry analyse using IC? Suppressed Conductivity Which detectors are used with IC in the bio/pharma industry? API, Counterions & Impurities most analysed Suppressed Conductivity & UV main detectors employed

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Page 1: Application of Ion Chromatography in the Bio/Pharma Industry › TFS-Assets › CMD › brochures › ... · 2017-12-13 · Usage of IC in the bio/pharma industry Currently Use Not

Usage of IC in the bio/pharma industryCurrently Use

Not Sure

Do Not Use

68%

18%

14%

Ultraviolet(UV/Vis)

Conductivity Pulsed Amperometric

Detection (PAD)

Mass Spectrometry

(MS)

Fluorescence Evaporative Light

Scattering Detection

(ELSD)

Charged Aerosol

Detection (CAD)

Inductively Coupled

Plasma-MS (ICP-MS)

High Resolution MS

(HRMS)

Not Sure

38% 38% 33% 27% 22% 11% 9% 8% 8% 6% 11%

How do the bio/pharma industry use compendial monographs?

Use them as a minimum standard and stating point

Follow them word for word

Refer to the methods but don’t follow them

Planning to use them

Do not use them

Not Sure

Use them as a minimum standard and stating point

Follow them word for word

Refer to the methods but don’t follow them

Planning to use them

Do not use them

Not Sure

Are the bio/pharma industry familar with USP General Chapter <1065> ion Chromatography?

Yes No

18%

32%

31%

10%

6%3%

44%

56%

Modernizing pharmacopeial monographs with ICAnions and Cations in

a Drug FormulationAnions and Cations in

a Drug FormulationCurrent Monograph

Scenario

TOTAL # OF TESTS INVOLVED = 5 TOTAL # OF TESTS INVOLVED = 2

With the USP Modernization Initiative

Sodium

Potassium

Magnesium

Chloride

Acetate

Gluconate

Phosphate

Cationic IC

Cationic IC

Cationic IC

Anionic IC

Anionic IC

Anionic IC

Anionic IC

Flame photometry

Flame photometry

Atomic absorption

Titration with silver nitrate

Ion Exclusion Chromatography

Ion Exclusion Chromatography

Spectroscopic Procedure

More on Drug Monographs and Assays Using Ion Chromatographythermofisher.com/PharmaIC

Panel Discussion on Pharmacopeial Monograph Modernization and Ion ChromatographyRegister & Watch On-Demand Now 

©2017 Thermo Fisher Scienti�c. All rights reserved. ST72591-EN 1217S

Application of Ion Chromatography in the Bio/Pharma Industry

In August-September 2017 an online survey was conducted by the Analytical Scientist (a Texere

Publication) on behalf of Thermo Fisher Scientific. The intent was to learn more about the application

of ion chromatography (IC) in the bio/pharmaceutical industry and the level of awareness and

applicability of pharmacopeial monograph modernization. The qualified responses collected in the

survey are the basis for the data shared in this infographic.

APIs/Drug Substances..

Counterions ... of API or Drug Sustance

Impurities/degradants...

Excipients and inactive formulation components

Monosaccharides and sialic acids

Amino acids (in biologics drugs)

Antibiotics

Glycans (in biologics drugs)

Other (small molecules...)

Not Sure

49%

48%

32%

25%

19%

15%

13%

8%

8%

8%

What do the bio/pharma industry analyse using IC?

Suppressed Conductivity

Which detectors are used with IC in the bio/pharma industry?

API, Counterions & Impurities

most analysed

Suppressed Conductivity& UV main detectors employed