Tincture checking experiments
Tincture ("Chinese Pharmacopoeia" 2010 version of the second part of Appendix I C) refers to the drug with a prescribed concentration of ethanol leaching or dissolution and made of clarified liquid preparations, can also be made with the dilution of running paste, for oral or external use. Quality requirements for tinctures: in general, tinctures containing toxic drugs should be equivalent to 10 g of the original drug per 100 ml, and other tinctures should be equivalent to 20 g of the original drug per 100 ml The solution of the tincture should be clarified, and if precipitation occurs as a result of prolonged storage, it can be removed by filtration when the content of ethanol and the active ingredient is in accordance with the provisions of the regulations; tincture should be examined for the amount of ethanol, and the test items stipulated under the varieties of the pharmacopeia should also be examined in addition to "filling"; the amount of ethanol should also be examined. In addition to the tests specified in the Pharmacopoeia under the species, it should also check the "loading" and "microbial limit", oral tincture should check the "amount of methanol".
Operation method
"Volume" checking method
Principle
This method is based on the Minimum Volume Inspection Method (Appendix X F of the Chinese Pharmacopoeia, 2010 Edition, Part II) and is applicable to the volume inspection of tinctures. The purpose of this test is to control the minimum quantity of tinctures with a labeled quantity of 500 ml or less.
Materials and Instruments
tincture Move I. Instruments and Appliances Caveat Volumetric method of checking, the syringe or cylinder must be clean, dry, and regularly calibrated; its maximum scale value should be consistent with the labeled amount of test material, or not more than two times the labeled amount. For more product details, please visit Aladdin Scientific website.
Water
Syringes Measuring cylinders
1. Syringes are standardized for labeled volumes of 2 ml or less.
2. Measuring cylinders (drop-in type) are standardized for use with marked volumes of 2 ml or more.
II. Methods of operation
1. The labeled quantity of the tincture is measured in volume and is checked by the volumetric method.
2. Take 5 test pieces of the labeled amount of 50 ml or less, shake well, open the container carefully, draw out the contents with a dry syringe to remove air or take 3 test pieces of the labeled amount of 50 ml or more, shake well, open carefully, pour the contents into a dry cylinder, and invert the container for 15 minutes to pour out as much as possible.
3. Read the contents of each container to three significant figures.
III. Records and calculations
1. Record the room temperature, the number of test vials (sticks) taken, the labeled amount of test material, and the measured amount of test material per vial (stick).
2. Find the average loading (to three significant figures).
3. The results of the retest, if any, shall be recorded.
IV. Results and determinations
1. Each packaging is judged to be in compliance when its contents and its average filling comply with the provisions of the following table.Labeled quantity Average quantity Quantity per container Up to 20 ml Not less than the labeled volume Not less than 93% of the labeled volume 20 ml to 50 ml not less than the labeled quantity not less than 95% of the labeled quantity 50 ml or more not less than the labeled quantity not less than 97% of the labeled quantity
2. If the filling of only one container does not comply with the provisions of the above table, but its average filling is not less than the labeled filling, another test article shall be taken and retested in accordance with items 2 and 3; if the results of the retest are all in accordance with the provisions of the above table, it shall still be judged to be in conformity with the regulations.
3. preliminary examination results in the average filling less than the indicated filling, or 2 or more containers of the filling does not comply with the provisions, or in the retest still can not all comply with the provisions, are judged to be not in accordance with the provisions.