USP Application Compendium

Learn more about USP monograph and other applications for FTIR, GC, Residual Solvents per USP <467>, HPLC including modernization of methods per USP <621>, Physical Testing per USP <915> and <1912>, TOC per USP <643> and <661.1-2>.

FTIR & UV-Vis

• Analysis of Dimethicone Based on USP-Specified Method
• Measurement of Impurities in Ethanol Using UV-Vis Spectrophotometer
• Instrumental Validation of UV-Visible Spectrophotometer Compliant with JP, EP and USP – Application of Instrumental Validation Functions of UV-1900

Gas Chromatography

• Determination of Organic Impurities from Valproic Acid as per proposed USP monograph GC method
• Determination of Epichlorohydrin from Sevelamer carbonate as per proposed USP monograph GC method
• Alcohol Determination of Sanitizer Gel in accordance with USP <611>
• System Suitability Test of Low-Substituted Hydroxypropyl Cellulose for USP42-NF37
• Analysis of Volatile Impurities in Anhydrous Ethanol and Ethanol for Disinfection in Accordance with the Purity Test set by the Pharmacopoeias (JP, USP, EP)

Gas Chromatography - Residual Solvents

• Analysis of Residual Solvents in Pharmaceuticals An Analysis Method for Class 2 Solvents (Water- vSoluble Samples) Unsuited to Headspace GC Methods
• Analysis of Residual Solvents in Pharmaceuticals by Nexis™ GC-2030 + HS-20 (JP17 Supplement II, USP 467)
• Analysis of Residual Solvents in Pharmaceuticals by Water-Soluble Samples Using N2 Carrier (JP17 Supplement II, USP 467)
• Analysis of Residual Solvents in Pharmaceuticals by Water-Insoluble Samples Using N2 Carrier (JP17 Supplement II, USP 467)
• Efficient Analysis of Residual Solvents in Pharmaceuticals Using the Compact Model, Brevis GC-2050—JP18 and USP467, Water-Soluble Sample
• Residual Solvents Analysis in Pharmaceuticals by HS-GC-FID with Newly Added Compounds –USP <467> Procedure A
• Analysis of Residual Solvents in Pharmaceuticals by Water-Insoluble Samples Using H2Carrier (USP 467)
• Efficient Analysis of Residual Solvents in Pharmaceuticals Using the Compact Model, Brevis GC-2050 (2)
• Using GCMS to Test for Residual Solvents in Pharmaceuticals

High Performance Liquid Chromatography

• High Speed Analysis of Budesonide in Accordance with Chapter 621 in USP 40
• Analysis of Fingolimod Hydrochloride According to the USP Monograph 1745
• High Speed Analysis of Pregabalin in Accordance with Chapter 621 in USP 40
• USP Analysis of Almotriptan Tablets and Related Substances
• Analysis of Mannitol Using RID-20A Differential Index Detector
• Analysis of Omeprazole by "i-Series" for USP and JP Methods
• Analysis of Montelukast Sodium Using Prominence-i and Nexera-i MT
• High-Speed Analysis of Pramipexole following the Draft Guidance of International Harmonization of Pharmacopoeias
• High-Speed Analysis of Linezolid following the Draft Guidance of International Harmonization of Pharmacopoeias
• Analysis of Meloxicam in Accordance with the United States Pharmacopoeia by Nexera XR
• Analysis of Cyanocobalamin tablets, assay procedure 2 as per USP41-NF36 monograph, using Shimadzu Nexera X2 Fast LC System
• High Speed Analysis of Phenytoin in accordance with chapter 621 in USP 39
• High Speed Analysis of Indometacin in accordance with chapter 621 in USP 39
• High Speed Analysis of Topiramate in accordance with chapter 621 in USP 39
• Application of HPLC in Quality Analysis of Hydroxychloroquine Sulfate
• Organic Impurity Analysis of Cetirizine Hydrochloride Drug Material Following USP Monograph
• Determination of Dexamethasone and its organic impurities content as per USP monograph UHPLC method
• Organic Impurity analysis of Levofloxacin Drug Material following USP monograph
• Analysis of Elemental Impurities in Medium chain Triglycerides According to USP

Inductively Coupled Plasma Mass Spectrometry

• Analysis of Dimethicone Based on USP-Specified Method

Physical Testing

• Evaluation of Structural Strength of Semisolids Conforming to USP 915 and USP 1912 by Penetration Method

TOC (Total Organic Carbon)

• TOC Measurement of Pharmaceutical Water
• TOC System Suitability Test for Sterile Water According to USP
• TOC System Suitability Test Using TOC-1000e According to USP 643
• TOC – Determination according to USP 661.1 Testing of Plastic Packaging Systems and their Materials of Construction
• TOC – Determination according to USP 661.2 Testing of Plastic Packaging Systems and their Materials of Construction

EDX

• ICH Q3D Elemental Impurities Analysis of Tablets by EDX