Organic drugs charred by incineration, then add sulfuric acid wet, low temperature heating to sulfuric acid vapor removal, at high temperature (700 ~ 800℃) incineration to complete ash, so that the destruction of organic material decomposition into volatile substances escape, non-volatile inorganic impurities (mostly metal oxides or salts) become sulfate, known as incineration residue. The residue on ignition check method is used as an indicator to control the quality of API. Among them, volatile inorganic drugs such as hydrochloric acid, ammonium chloride, by heat volatilization or decomposition, residual non-volatile impurities, so also according to the above method to check the burning residue.
Drug incineration residue limit is generally 0.1% to 0.2%, according to the drug specified in the incineration residue limit to determine the amount of test samples taken. If the limit is 0.1%, sampling about 1 g; if 0.05%, sampling about 2 g; in more than 1%, sampling can be in 1 g or less. In the case of precious drugs or insufficient number of test products, the sample size can also be reduced as appropriate. When the results are judged, the value of incineration residue is less than or equal to the limit, it is judged to be in accordance with the provisions; its value is greater than the limit, it is judged not to meet the provisions.
CD Formulation offers a professional drug residue on ignition test, which assesses the quality of a drug by heating the drug to char and then ashing it.
Take a clean crucible and place it in a high-temperature furnace, cover the crucible cover obliquely on the crucible, heat it to 700-800℃ for about 30-60 min, stop heating, wait for the temperature of the high-temperature furnace to cool down to about 300℃, take out the crucible, place it in a suitable desiccator, cover the crucible cover, let it cool down to room temperature, and weigh the crucible precisely.
Take the specified weight of each species, place it in the crucible which has been incinerated to constant weight, and weigh it precisely.
Place the crucible with the test article on the electric furnace and burn slowly until the test article is all charred black and no longer smokes, then cool to room temperature.
Add sulfuric acid drop by drop, make the charcoal all wet, continue to heat on the electric furnace until the sulfuric acid vapor is removed, and the white smoke disappears completely. Place the crucible in a high-temperature furnace, cover the crucible with a slanting lid, and incinerate at 700-800℃ to completely ash the test article.
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