Non-volatile Residue testing has three different types in the medium.
- Water
- Alcohol
- Hexane
Preparation of apparatus
Take a glass stopper, 250 ml graduated cylinder of type I Glass. Clean glassware thoroughly with hot nitric acid and rinse with water. Successive cleaning with acetone and methylene chloride. Clean all other equipment by scrubbing with a suitable detergent and prolonged rinsing with water. The container and equipment used for extraction.
Preparation of sample
Take a sample of an HDPE Container portion of 120 cm2 total surface area (both sides combined). It is subdivided into 3mm in width and 5cm in length.
Transfer the subdivided sample to a glass stopper, 250ml graduated cylinder of type I glass, and add 180ml of water to rinse the sample for about 30 seconds to drain off the water. Repeat with a second washing.
- Water medium
Transfer the prepared sample and add 150 ml of water medium extraction flask, extract by heating in a water bath at 700c temperature for 24 hours, cool, but not below 200c.
Take two a fused silica crucible that has been acid-cleaned. Take the tarred weight of both crucibles at analytical balance. Transfer 50 ml of extract of the prepared sample to the tarred crucible. Add in another crucible 50ml of water. Evaporates the volatile matter in a water bath at 700c till the sample evaporates.
The difference between the amounts obtained from the specimen and the blank does not exceed 12 mg
2. Alcohol medium
Transfer the prepared sample and add 150 ml of ethanol medium extraction flask, extract by heating in a water bath at 700c temperature for 24 hours, cool, but not below 200c.
Take two a fused silica crucible that has been acid-cleaned. Take the tarred weight of both crucibles at analytical balance. Transfer 50 ml of extract of the prepared sample to the tarred crucible. Add in another crucible 50ml of Ethanol. Evaporates the volatile matter in a water bath at 700c till the sample evaporates.
The difference between the amounts obtained from the specimen and the blank does not exceed 75 mg
3. Hexane medium
Transfer the prepared sample and add 150 ml of Hexane medium extraction flask, extract by heating in a water bath at 500c temperature for 24 hours, cool, but not below 200c.
Take two a fused silica crucible that has been acid-cleaned. Take the tarred weight of both crucibles at analytical balance. Transfer 50 ml of extract of the prepared sample to the tarred crucible. Add in another crucible 50ml of Hexane. Evaporates the volatile matter in a water bath at 500c till the sample evaporates.
The difference between the amounts obtained from the specimen and the blank does not exceed 100 mg
I am Maneesh Maurya a professional pharmaceutical blogger from India having rich experience in the pharmaceutical Quality control field.
