Dangerous chemicals that shall be tested in Propylene Glycol before using it in medicinal preparations.
Kids Death due to syup. A syrup is a dosage form mostly used to provide medicine to kids because it is easy to take. Kids may not be able to swallow tablets or capsules etc. To prepare a syrup medicine needs to be dissolved. Some medicines which are not soluble in water are made soluble in other solvents. Main solvent used is Propylene Glycol due to its colorless, odorless and slightly sweet taste. Propylene Glycol is also used for preparation of Injections like Paracetamol Injection, Oxytetracycline Injection, Diclofenac Injection etc.
Propylene Glycol must be tested to ensure that it does not contain Diethylene Glycol and Ethylene Glycol. This test is done by a Gas Chromatography instrument. Propylene Glycol of IP, BP, USP or Pharmacopoeia Grade is not supposed to contain Diethylene Glycol and Ethylene Glycol. If the drum contains the words IP BP USP then it shall be free from Diethylene Glycol and Ethylene Glycol. To ensure that Propylene Glycol is free from these poisonous chemicals every pharmaceutical company using it must conduct tests for the absence of these chemicals. If the test for Diethylene Glycol and Ethylene Glycol is not done then it may be fatal for consumers.
Diethylene Glycol and Ethylene Glycol acts on Nervous System and Kidneys where kidney failure may occur if proper treatment is not given on time. This is what happens in developing countries where medical care facilities are limited. Propylene Glycol is used in the paint industry also and for making several such products which are not for human or animal consumption.
Propylene Glycol used in the Paint industry can contain Diethylene Glycol and Ethylene Glycol. If Propylene Glycol of Paint industry Grade is used by the pharmaceutical industry then results can be fatal. Propylene Glycol has been causing deaths in kids since the 1930’s. Propylene Glycol shall be made a controlled substance by FDA. FDA shall issue permits for purchase of Propylene Glycol so that industrial grade Propylene Glycol which may contain Diethylene Glycol and Ethylene Glycol is not used for manufacturing of syrup or oral liquids. An Industry making Pharmacopoeia Grade Propylene Glycol performs all tests including Diethylene Glycol and Ethylene Glycol.
Commercial or industrial grade Propylene Glycol making companies are not legally required to do tests for absence of Diethylene Glycol and Ethylene Glycol because their product is not for human animal consumption.
