Anybody inquired about Ramipril, Benzapril, Quinapril?

[Naiffer_Host]

We have had several ongoing discussions within the community regarding N-nitroso-Quinapril, and the Prils (ACE Inhibitors) class.
I recently participated in USP’s Nitrosamine Workshop (India) and received several inquiries about Ramipril, Benzapril, and Quinapril… Is anybody receiving questions from regulatory agencies about these products? Any agreement on the limits?

Class features:

• benazepril (Lotensin, Lotensin Hct), - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.
• captopril (Capoten) – No secondary amine, hence not possible.
• enalapril (Vasotec), - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.
• fosinopril (Monopril) – No Secondary amine, hence no possibility.
• lisinopril (Prinivil, Zestril) - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.
• moexipril (Univasc) - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.
• perindopril (Aceon) - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative
• quinapril (Accupril), - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.
• ramipril (Altace), - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.
• trandolapril (Mavik) - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.

Summary of community discussions:

N-nitroso-quinapril

Three days after propranolol was recalled, Pfizer Canada recalled all lots of Accuretic(quinapril hydrochloride and hydrochlorothiazide), which is also used for blood pressure medication, due to N-nitrosamine contamination. [image] N-nitroso-quinapril https://recalls-rappels.canada.ca/en/alert-recall/pfizer-recalls-accuretic-blood-pressure-tablets-due-nitrosamine-impurity Inactive ingredients used in the formulation is as follows; candelilla wax, crospovidone, hydroxypropyl cellulose, hypro…

Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two lots of Quinapril and Hydrochlorothiazide Tablets due to presence of NDSRI, N-Nitroso-Quinapril above the proposed interim limit

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-recall-two-2-lots-quinapril-and

Exact Root causes for NDMA in Metformin & NDSRI's Impurities in Varenicline, Quinapril & Orphenadrine

Dear Team, (David, Naiffer, Yosuke), Could you please share your opinion for Exact Root causes for NDMA in Metformin & NDSRI’s Impurities in Varenicline, Quinapril & Orphenadrine as like “NDMA in Valsartan due to Tetrazole ring” & “NDMA in Ranitidine due to Storage time”. Actually, I am unable to trace out, the exact root cause for NDMA in Metformin ER Tablet and NDSRI’s Impurities in Varenicline tablet, Quinapril HCL tablet & Orphenadrine Citrate ER Tablets, in FDA website (Recall product lin…

Voluntary Recall of lots of ACCUPRIL tablets

Pfizer is voluntary recalling 5 lots of Quinapril HCl tablets due to presence of N-nitroso-quinapril above the ADI level. More details about the recall are in enclosed link​: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuprilr-quinapril-hcl-due-n-nitroso-quinapril-content?utm_medium=email&utm_source=govdelivery

Recall of lots of Accuretic tablets by Pfizer

Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level. Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four …