Our commitment to research and analysis of Nitroso API places us in a leadership position in this field.
QPLAB has multiple in house developed and validated method for the determination of low-level nitrosamines screen using LC-MS. More than 75 API-specific methods for the determination of nitrosamines have already been developed by QPLAB.
Method Screening
QPLAB has develop analytical method to determine the hottest nitrosamines such as NDMA, NDEA, NMEA, NDPA, NPYR, NPIP, NEIPA, NDIPA, NMBA, NMPA, MeNP, NMOR and NDBA. The test will evaluate the existence of nitrosamines lower that 10% according to the maximum daily dosage,
Development methods
QPLAB develop customized analysis methods to meet the unique needs of our clients. Depending on the matrix measurements can be made on a concentration of 5 ppb. Definition and test performance of all analytical phases: sample preparation, extraction and detection parameters.
Validation method
Series of tests repetition and results statistical treatment to evaluate the method performance. Prior design of activity protocol with all related tests to be approved by customer. Execution of linearity, selectivity, LOD and LOQ, Precision, Accuracy, System suitability, Stability in Solution and Robustness
Specific API nitrosamines
The current analytical methods developed by QPLAB are capable of determining nitrosamines derived from API, such as:
| Rifampicin Opipramol Benzydamine Indapamide Sitagliptin Ropivacaine Ambroxol Atenolol Azacyclonol Azithromycin Betahistine Bilastine Bisoprolol Bumetanide Bupropion Caspofungin Cilazapril Ciprofloxacin Clozapine Dabigatran Etexilate Lidocaine Desloratadine |
Azelastine Azithromycin Chloropyramine Clarithromycin Citalopram Sildenafil Tramadol Valsartan Diclofenac Dorzolamide Enalapril Fluoxetine Hydrochlorothiazide Levofloxacin Lisinopril Meropenem Methylphenidate Metoprolol Mirtazapine Dimenhydrinate Diphenhydramine |
Valaciclovir Amitriptyline Nortriptyline Chloropyramine Perindopril Phenylephrine Piperidine Quinapril Ramipril Rasagiline Ribociclib Methylphenidate Rivaroxaban Salbutamol Sertraline Tamsulosin Terazosin Tetracaine Ticagrelor Tigecycline Trimetazidine Varenicline |
Raw materials
QPLAB offers additional tests to raw materials for nitrites and elemental impurities