Applications from the field of Pharma & Biopharma | LabRulez ICPMS

FDA 21 CFR Part 11 Requirements for NIR Spectroscopy

Technical notes

| 2017 | Metrohm

NIR Spectroscopy

Instrumentation

NIR Spectroscopy

Manufacturer

Metrohm

Industries

Pharma & Biopharma

FDA 21 CFR Part 11 Compliance by Metrohm Raman

Technical notes

| 2018 | Metrohm

RAMAN Spectroscopy

Instrumentation

RAMAN Spectroscopy

Manufacturer

Metrohm

Industries

Pharma & Biopharma

Using Chromeleon 7 Chromatography Data System to Comply with 21 CFR Part 11

Technical notes

| 2018 | Thermo Fisher Scientific

Software

Instrumentation

Software

Manufacturer

Thermo Fisher Scientific

Industries

Pharma & Biopharma

Support for Title 21 CFR Part 11 and Annex 11 Compliance: Agilent MicroLab Pharma

Technical notes

| 2020 | Agilent Technologies

Software, FTIR Spectroscopy

Instrumentation

Software, FTIR Spectroscopy

Manufacturer

Agilent Technologies

Industries

Pharma & Biopharma

Analysis of Potential Genotoxic Impurities in Active Pharmaceutical Ingredients (4) - Analysis of Haloalcohols and Glycidol Part 2 -

Applications

| 2012 | Shimadzu

GC/MSD, GC/SQ

Instrumentation

GC/MSD, GC/SQ

Manufacturer

Shimadzu

Industries

Pharma & Biopharma

Analysis of Potential Genotoxic Impurities in Active Pharmaceutical Ingredients (3) - Analysis of Haloalcohols and Glycidol Part 1-

Applications

| 2012 | Shimadzu

GC/MSD, GC/SQ

Instrumentation

GC/MSD, GC/SQ

Manufacturer

Shimadzu

Industries

Pharma & Biopharma

Impact of USP <1058> - Regulatory Spotlight on Analytical Instrument Qualification (AIQ)

Technical notes

| 2017 | Agilent Technologies

GC, GC/MSD, HPLC, LC/MS, SFC

Instrumentation

GC, GC/MSD, HPLC, LC/MS, SFC

Manufacturer

Agilent Technologies

Industries

Pharma & Biopharma

Sigma-Aldrich CMO helps customers comply with 21 CFR Part 11 using Chromeleon CDS software

Others

| 2016 | Thermo Fisher Scientific

Software

Instrumentation

Software

Manufacturer

Thermo Fisher Scientific

Industries

Pharma & Biopharma

Sigma-Aldrich CMO helps customers comply with 21 CFR Part 11 using Chromeleon CDS software

Others

| 2016 | Thermo Fisher Scientific

Software

Instrumentation

Software

Manufacturer

Thermo Fisher Scientific

Industries

Pharma & Biopharma

Analysis of Residual Solvents in Pharmaceuticals (Part 5) Comparison of Headspace GC Sensitivity when Using Different Dilution Solvents

Applications

| N/A | Shimadzu

GC, HeadSpace

Instrumentation

GC, HeadSpace

Manufacturer

Shimadzu

Industries

Pharma & Biopharma

Applications from the field of Pharma & Biopharma | LabRulez ICPMS

FDA 21 CFR Part 11 Requirements for NIR Spectroscopy

FDA 21 CFR Part 11 Compliance by Metrohm Raman

Using Chromeleon 7 Chromatography Data System to Comply with 21 CFR Part 11

Support for Title 21 CFR Part 11 and Annex 11 Compliance: Agilent MicroLab Pharma

Analysis of Potential Genotoxic Impurities in Active Pharmaceutical Ingredients (4) - Analysis of Haloalcohols and Glycidol Part 2 -

Analysis of Potential Genotoxic Impurities in Active Pharmaceutical Ingredients (3) - Analysis of Haloalcohols and Glycidol Part 1-

Impact of USP <1058> - Regulatory Spotlight on Analytical Instrument Qualification (AIQ)

Sigma-Aldrich CMO helps customers comply with 21 CFR Part 11 using Chromeleon CDS software

Sigma-Aldrich CMO helps customers comply with 21 CFR Part 11 using Chromeleon CDS software

Analysis of Residual Solvents in Pharmaceuticals (Part 5) Comparison of Headspace GC Sensitivity when Using Different Dilution Solvents

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