Olmesartan – A NDMA Free Drug Declared By FDA

Olmesartan – A NDMA Free Drug Declared By FDA

Published feb 22, 2020 by pharmaffiliates
Olmesartan – A NDMA Free Drug Declared By FDA

Over 350 million people in the world currently are suffering from Diabetes mellitus (DM) which is a major metabolic disorder that is prevalent in both developed and developing countries.

Diabetes mellitus leads to a chronic structural and functional impairment of vascular systems along with with several complications, including diabetic nephropathy (DN), the most common cause ofend-stage renal disease for which novel therapeutic modalities are urgently needed.

Olmesartan Medoxomil (OM) is an orally administered angiotensin II receptor blocker that is rapidly converted to active metabolite Olmesartanin vivo. U.S. FDA approved Olmesartan medoxomil for the treatment of hypertension in April 2002. A potential advantage of this drug is its once-daily dosage, absence of any significant side effect, well-tolerated and cost-effective.

Recently, Olmesartan medoxomil was in news for a great reason. On April 5, 2019, the FDA issued a list of 40 blood pressure medicines it found free of contamination with the chemical N-Nitrosodimethylamine, an ongoing issue that has triggered several medications recalls since last summer.

The list included drugs involved are medicines that lower blood pressure in a family of drugs known as ARBs. These include Telmisartan and Olmesartan which were never found to be contaminated with N-Nitrosodimethylamine, a cancer-causing chemical.

Olmesartan is therefore on a high priority of doctors as a prescription drug. The pharmaceutical industry is trying to meet the increasing demand along with maintaining the quality and efficacy of the drug.

It is important to identify, isolate, synthesize and characterize all the major impurities, metabolites, derivatives, intermediates, degradants, and stable isotopes of Olmesartan to obtain a high purity drug product.

Some of the known and unknown impurities of Olmesartan are tabulated

Chemical Name Product Name Cas No.
Olmesartan Dehydro Olmesartan Dehydro - API 172875-98-8
Olmesartan Acid Olmesartan - Impurity A 144689-24-7
Olmesartan Lactone Olmesartan - Impurity B 849206-43-5
Dehydro Olmesartan Medoxomil Olmesartan - Impurity C 879562-26-2
Trityl Olmesartan Medoxomil Olmesartan - Impurity D 1020157-01-0
Olmesartan Dimer Ester Impurity Olmesartan Dimer Ester Impurity 1040250-19-8
Olmesartan Ethyl Ester Olmesartan Ethyl Ester 144689-23-6
Olmesartan Methyl Ester Olmesartan Methyl Ester 1347262-29-6
4-Chloro-4-methyl-5-methylene-1,3-dioxolan-2-one 4-Chloro-4-methyl-5-methylene-1,3-dioxolan-2-one 95579-71-8
Ethyl 5-(2-methoxypropan-2-yl)-2-propyl-1H-imidazole-4-carboxylate Ethyl 5-(2-methoxypropan-2-yl)-2-propyl-1H-imidazole-4-carboxylate 1092980-84-1
2-Propyl-1H-benzimidazole 2-Propyl-1H-benzimidazole 5465-29-2
Olmesartan Imidazole Diacid Impurity Olmesartan Imidazole Diacid Impurity 58954-23-7
Olmesartan Dimer Impurity Olmesartan Dimer Impurity NA
Trityl Olmesartan Dimer Impurity Trityl Olmesartan Dimer Impurity NA
Olmesartan Desmethyl Olmesartan Desmethyl NA
Mixture of (OLM-6(MTT) +OLM-5(MTT-Acid) + TPC+ MTT-Cl +MTT Eliminate +MTT methyl + Desmethyl Ethyl MTT + OLM-7) Mixture of (OLM-6(MTT) +OLM-5(MTT-Acid) + TPC+ MTT-Cl +MTT Eliminate +MTT methyl + Desmethyl Ethyl MTT + OLM-7) NA
1-((2'-(1-(1-((2'-(1H-Tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1H-imidazole-5-carbonyl)-1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1H-imidazole-5-carboxylic Acid 1-((2'-(1-(1-((2'-(1H-Tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1H-imidazole-5-carbonyl)-1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1H-imidazole-5-carboxylic Acid NA
4-(1-Hydroxy-1-methylethyl)-2-propyl-1H-imidazole-5-carboxylic Acid Ethyl Ester 4-(1-Hydroxy-1-methylethyl)-2-propyl-1H-imidazole-5-carboxylic Acid Ethyl Ester 144689-93-0
4-Acetyl-2-propyl-1H-imidazole-5-carboxylic Acid Ethyl Ester 4-Acetyl-2-propyl-1H-imidazole-5-carboxylic Acid Ethyl Ester 144690-07-3
N-Trityl Olmesartan Ethyl Ester N-Trityl Olmesartan Ethyl Ester 172875-59-1
2-Propyl-1H-imidazole-4,5-dicarbonitrile 2-Propyl-1H-imidazole-4,5-dicarbonitrile 51802-42-7
Olmesartan Imidazole Diethyl Ester Impurity Olmesartan Imidazole Diethyl Ester Impurity 144689-94-1
4-(Chloromethyl)-5-methyl-1,3-dioxol-2-one 4-(Chloromethyl)-5-methyl-1,3-dioxol-2-one 80841-78-7
Ethyl 4-(2-Hydroxypropan-2-yl)-2-propyl-1-((2'-(1-trityl-1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-imidazole-5-carboxylate Ethyl 4-(2-Hydroxypropan-2-yl)-2-propyl-1-((2'-(1-trityl-1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-imidazole-5-carboxylate 144690-33-5
(4R,5S)-4,5-Dichloro-4,5-dimethyl-1,3-dioxolan-2-one (4R,5S)-4,5-Dichloro-4,5-dimethyl-1,3-dioxolan-2-one 116857-04-6

The Impurity Reference Standards (IRSs) are designed to detect, identify, quantify and qualify impurities in a drug substance in accordance with the ICH guidelines (Q3A to Q3D and Q7).

These IRSs shall be obtained from a known and reliable source along with certificates of analysis (CoAs). The information provided on the CoA should be suitable with regard to the specific use planned for the corresponding RS.

Pharmaffiliates Analytics and Synthetics Pvt. Ltd. is a trusted partner in the Pharmaceutical fraternity as an Impurity Reference Standard manufacturer, supplier, and exporter.

Apart from IRSs, Pharmaffiliates also deals in Primary Reference standards, Secondary Reference Standards and Pharmacopeial Reference Standards used in the Pharmaceutical industry, Food and Beverages, Phytochemistry, Environmental use, and Agricultural industry.

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