1. Purpo: To establish a standard operating procedure for the determination of
water, and to ensure the smooth progress of water determination
method.
抗组胺药物
2. Scope of Application: This procedure is applicable for the determination of water
content. .
3. Responsibility: The QC laboratorians are responsible for the implementation of
this procedure, and the laboratory director shall assume the
responsibility of the supervision and inspection for the effective
implementation of this procedure
4. Contents:
4.1 According to the Volume I of the China Pharmacopoeia (2010 edition).
4.2 Oven drying method (the first method): This method is applicable for the products
without or with less volatile components.
4.2.1 Instruments and materials: analytical balance, drying oven, weighing bottle and
the dryer.
4.2.2 Determination method: This method is applicable for the products without or with
春节绘画作品大全less volatile components. Take 2 ~ 5 g of test products, spread flat on a weighing bottle that have been dried to constant weight with a thickness not exceeding 5 mm. Thickness of the loo test products shall be no more than 10 mm. Weigh accurately, and open the bottle to dry at 100 ~ 105°C for 5 hours. Then cover the lid, move into the dryer, cool for 30 minutes and
weight accurately. In quence, repeat the above steps, dry at the above temperature for 1 hour, cool and weigh, until the difference between the two concutive weights does not exceed 5 mg.
4.2.3 Calculation: According to the weight loss, calculate water content (%) in the test
sample
Water content % = W2
×100% W1
W2 is the weight loss of the test product;
W1 is the weight of the test product.
4.3 Methylbenzene method (the cond method): This method is applicable for the
products containing volatile components.
4.3.1 Instruments and appliances: moisture meter, long brush, electric jacket.
4.3.1.1 Instruments: A reprents for a 500 ml short-necked round-bottom flask; B for
moisture test tube; C for straight condenr tube with the outer concentric tube
at 40 cm in length. Before u, all the instruments shall be cleaned and dried
in an oven.
4.3.2 Reagents and test solutions: methylbenzene, methylene blue powder.
4.3.2.1 Determine directly with methylbenzene of chemical pure. Add a small amount
of water into the methylbenzene if necessary, shake well and place still until
菠萝玉米
layering, then discard the water layer and u after distilled.
4.3.3 Determination method: Take a certain amount of test product (approximately
西湖音乐喷泉equivalent to water content of 1 ~ 4 ml), weigh accurately, and transfer into flask
A. Add 200 ml of the methylbenzene, and add a few of dried and clean glass里格岛
beads when necessary, connect all parts of the instrument, add the methylbenzene from the top of the condenr pipe until the narrow part of tube B is filled. Place bottle A into the electric jacket or heat slowly with other appropriate methods. At the beginning of the methylbenzene boiling, adjust the temperature to control the distillation speed of 2 drops/s. With the water distilled out completely, i.e. the scale of water in the measuring tube is no longer increasing, wash the internal of the condenr with the methylbenzene, then u long brush
dipped with methylbenzene or other suitable means, to push out the methylbenzene being attached to the wall of the condenr, and continually distill for 5 minutes, cool to room temperature, and disasmble the device. In ca of water adhering to the wall of tube B, push with copper wire dipped into methylbenzene, place still until the complete paration of the water with methylbenzene (Add a small amount of methylene blue powder to stain the water into blue for paration and obrvation).
4.3.4 Calculation: check and read the water volume, and calculate the water content in
the test product.
Water content % = V × d
×100% W
V is the volume of water checked and read (ml);
d is th
e proportion o
气血亏虚的症状f water
W is the weight of the test product.
4.4 Vacuum drying method (the third method): This method is applicable for the
precious herbs containing volatile components.
4.4.1 Instruments and appliances: vacuum dryer, analytical balance, weighing bottle. 4.4.1.1 Vacuum dryer: Take culture dish with the diameter of 12cm, spread an
appropriate amount of fresh phosphorus pentoxide desiccant onto it with
thickness of 0.5 ~ 1cm, then place into vacuum dryer with the diameter of
30cm.
人民的名义反派4.4.2 Determination method: take 2 ~ 4g of test products, mix well. Then take描写四季的诗
about 0.5 ~ 1g to put into the weighing bottle which has been dried and weighed under the same test conditions for test products, accurately weigh, open the bottle, place into the abovementioned vacuum dryer under 2.67kPa (20mmHg) pressure for half an hour, place at room temperature for 24 hours. Drying tube filled with fresh anhydrous calcium chloride is connected to the outlet of the vacuum dryer, then open the piston until the consistency is achieved between the internal and external pressures, then clo the piston, open the dryer, cover with lid, take out quickly, accurately weigh the bottle weight.
4.4.3 Calculate the water content (%) of the test product
Water content % = W2
×100% W1
Of which W 2 is the weight loss of the test product;
W 1 is the weight of the test product.
5.The QC unit is responsible for the drafting of this document; the QC director is
responsible for its review; and the director of Quality Department is responsible for its approval.
