How do you detect NDMA?
Table of Contents
How do you detect NDMA?
HPLC is the most popular technique for quality control of APIs and products in routine analysis, and it is preferable if NDMA impurity is simultaneously detected with drug substances by a single HPLC analysis.
What is NDMA used for?
N-nitrosodimethylamine, or NDMA, is a yellow, odorless liquid chemical once used to make rocket fuel. It is also a byproduct of several manufacturing processes and water chlorination. Small amounts of NDMA may occur in water, soil and air. It’s been classified as a probable human carcinogen.
What is NDMA contaminant?
N-nitrosodimethylamine (NDMA) is a hepatotoxic agent and carcinogen contaminant in commonly used medications such as valsartan, losartan, irbesartan, and ranitidine.
What drugs have NDMA in them?
To date, the FDA has found excessive amounts of NDMA in several lots of angiotensin receptor blockers (ie, valsartan, losartan, and irbesartan), metformin extended release products, and ranitidine tablet and syrup products.
How do you test for nitrosamines?
How do you test for NDMA? Nitrosamine impurities such as NDMA and NDEA can be analyzed and quantified using gas chromatography or high performance liquid chromatography coupled with an high-resolution mass spectrometer.
Is NDMA polar?
Due to the presence of polar functional groups, NDMA is hydrophilic, with a log Kow value of 20.57 (ATSDR, 1989). As a result, NDMA sorbs poorly to soil, activated carbon, and other sorbents.
How is NDMA formed?
N-nitrosodimethylamine (NDMA) is a disinfection byproduct that is formed during drinking water treatment with chloramines. It is preferentially formed by the reaction of chloramine with secondary, tertiary or quaternary amines (Schreiber and Mitch, 2006).
How is NDMA produced?
In water and soil, NDMA forms by the reaction of widely occurring primary, secondary or tertiary amines in the presence of nitrite. NDMA commonly occurs at low levels as a byproduct of disinfection in water treatment plants during the chlorination or chloramination of drinking water and wastewater.
Is NDMA still in Zantac?
FDA has found N-nitrosodimethylamine (NDMA) levels in some ranitidine products increase with time and temperature posing a risk to consumers, and therefore the agency has requested the withdrawal of all ranitidine products from the U.S. market. Consumers should stop taking any OTC ranitidine they may currently have.
How do you reduce nitrosamine?
Vitamin E and selenium have been found to minimize or prevent the reaction of nitrites/nitrates with amines and hence prevent or reduce the formation of carcinogenic nitrosamines. Vitamin C (ascorbic acid) is known to inhibit nitrosamine formation.
How many nitrosamine impurities are there?
seven nitrosamine impurities
FDA has identified seven nitrosamine impurities that theoretically could be present in drug products: NDMA, N-nitrosodiethylamine (NDEA), N-nitroso-N-methyl-4-aminobutanoic acid (NMBA), N-nitrosoisopropylethyl amine (NIPEA), N-nitrosodiisopropylamine (NDIPA), N- nitrosodibutylamine (NDBA), and N- …
Is NDMA volatile?
It is one of the simplest members of a large class of N-nitrosamines. It is a volatile yellow oil. NDMA has attracted wide attention as being highly hepatotoxic and a known carcinogen in laboratory animals.
How does NDMA get into water?
NDMA can occur in water, air, and soil as a result of chemical reactions with naturally occurring substances. NDMA also is produced when chloramines (a disinfectant) react with compounds in water and thus it is an unintended disinfection byproduct at some water treatment plants that ends up in the drinking water.
How does NDMA affect the body?
❖ Exposure to high levels of NDMA may cause liver damage in humans (ATSDR 1999; HSDB 2012). ❖ Potential symptoms of overexposure include headache, fever, nausea, jaundice, vomiting, abdominal cramps, enlarged liver, reduced function of liver, kidneys and lungs and dizziness (HSDB 2012; O’Neil 2006).
Is ranitidine still available 2021?
Since ranitidine is no longer on the market, consumers may be searching for alternatives. In addition to FDA-recommended Zantac alternatives, consumers may be able to make diet and lifestyle changes to manage heartburn. Zantac alternatives recommended by the FDA include: Prilosec (omeprazole)
