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Application Notes

Effective Nitrosamines Analysis in Drugs and Solvents

Updated

Discover methods for the quantitation of various nitrosamines in drugs and solvents using Shimadzu LC/MS or GC/MS instruments, including: 1) Quantitation of 6 Nitrosamines in 5 Sartans by LC-MS/MS system as per the proposed USP General Chapter <1469>, 2) Quantitation of 6 Nitrosamines in Losartan API by LC-MS/MS system as per the proposed USP General Chapter <1469>, 3) Quantitation of 7 Nitrosamines in API by HSGC-MS/MS as per proposed USP General Chapter <1469> and 4) Quantitation of 8 Nitrosamines in 12 different solvents by LC-MS/MS system.

A nitrosamine (NSA) is any molecule containing the nitroso functional group. Although nitrosamines are also present in some foods and drinking water supplies, their presence in drugs is considered unacceptable. These application notes describe the quantitation of various nitrosamines in drugs and solvents using Shimadzu LC/MS or GC/MS instruments.

Quantitation of 6 Nitrosamines in 5 Sartans by LC-MS/MS system as per the proposed USP General Chapter <1469>

Shimadzu_Nitrosamines_App1In this application note, we describe a single LC/MS method for the quantitation of 6 nitrosamines in 5 sartans as per proposed USP general chapter <1469> (procedure-3). The LCMS-8045 system used easily meets the requirements of the USP.

Who should view:
Labs/CROs wanting to detect nitrosamines in sartans in compliance with USFDA requirements.

Quantitation of 6 Nitrosamines in Losartan API by LC-MS/MS system as per the proposed USP General Chapter <1469>
Shimadzu_Nitrosamines_App2This application note describes a method for the detection of 6 nitrosamines in Losartan using the LCMS-8045 system. The highly-sensitive LCMS-8045 easily meets the criteria as per the proposed USP general chapter <1469> (procedure-3).

Who should view:
Labs/CROs wanting to detect nitrosamines in sartans (especially Losartan) in compliance with USFDA requirements.

Quantitation of 7 Nitrosamines in API by HSGC-MS/MS as per proposed USP General Chapter <1469>
Shimadzu_Nitrosamines_App3In this application note, we describe the quantitation of 7 nitrosamines in Losartan, not only the 4 nitrosamines specified in the USP, but an extra 3 which can be detected using Shimadzu’s methods. The Shimadzu GCMS-TQ8050 NX provides excellent sensitivity several times that required by the FDA.

Who should view:
Labs/CROs wanting to detect nitrosamines in various pharmaceuticals (especially Losartan) with GC/MS.

Quantitation of 8 Nitrosamines in 12 different solvents by LC-MS/MS system
Shimadzu_Nitrosamines_App4A single LC-MS/MS method has been developed for the determination of 8 nitrosamines in different solvents using the LCMS-8045 system. Three pretreatment methods are described for different types of solvent. Regulatory requirements for nitrosamine levels were easily met thanks to the high sensitivity of the Shimadzu LCMS-8045.

Who should view:
Labs/CROs wanting to detect nitrosamines in various solvents.



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