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This product is calculated on dry goods, per 1mg potency is not less than 975 units of tetracycline hydrochloride.
?Properties? This product is light yellow crystalline powder; odorless; placed after deep color gradient, color in daylight rapidly become darker in alkaline solution This product is slightly soluble in ethanol, very slightly soluble in water, insoluble in chloroform or ether, dissolved in dilute acid.
Absorption coefficient of this product 10mg, accurately weighed, set 100ml flask, add salt acid (0.1mol / L) 10ml dissolved, diluted with water to the mark, the precise amount of 10ml, 75ml of water and sodium hydroxide solution (2mol / L ) 12ml, diluted with water to 100ml, and mix. According to spectrophotometry (Chinese Pharmacopoeia 1985 edition two Appendix 20), at 380 ± 1nm wavelength determination, since the sodium hydroxide solution (2mol / L) within 6 minutes, the absorption coefficient (E1% 1cm) should 390 ~ 420.
[Identification] (a) the product of about 0.5mg, sulfuric acid 2ml, which were dark purple, plus 1 drop of ferric chloride solution, the solution turns reddish brown.
(2) to take this product with tetracycline hydrochloride standard, were added methanol containing 0.5mg per 1ml of the solution, according to relevant material under thin layer chromatography test, learn the two solutions 1?l, respectively, points on the same plate with the test of the significant main spots of color and location should be the same as with the standard spots.
[Check] acidity of this product, add water containing 10mg per 1ml suspension, according to the determination (Chinese Pharmacopoeia 1985 edition two Appendix 33), pH value should be 3.0 to 7.0 .
For substances of this product, the addition of methanol per 1ml solution containing 5mg (1); precision that take four - Poor to dehydration tetracycline reference standard amount of methanol produced per 1ml solution containing 0.025mg (2); Weigh tetracycline hydrochloride with a 4 - Poor to dehydration tetracycline reference standard amount of methanol produced per 1ml containing the tetracycline hydrochloride 0.05mg with a 4 - Poor tetracycline 0.025mg to dehydration mixture (3), thin layer chromatography method test (Chinese Pharmacopoeia 1985 edition two Appendix 26), to learn the three solutions 1?l, respectively, in the same plate with ethyl acetate - acetone - water (60:30:6) as the agent, at room temperature 14 ~ 24 ? expanded, air dried, smoked with ammonia vapors, UV light (365nm), under review, the solution (a) the fluorescence intensity of the spots were the solution (2) of the corresponding spots were fluorescence intensity compared to no more solution (3) should be displayed two distinct spots, or should be re-test.
Impurity absorption of this product 50mg, accurately weighed, set 25ml volumetric flask, add salt acid (0.1mol / L) 2.5ml dissolved, diluted with water to the mark, according to spectrophotometry (Chinese Pharmacopoeia 1985 edition of Appendix 20 ), 1 hour at 430 ± 1nm wavelength determination, the absorption Drying of this product, at 105 ? drying to constant weight, less weight loss should not exceed 10.0% (Chinese Pharmacopoeia 1985 edition two Appendix 40).
Heavy metals in this product 0.5g, according to inspection (Appendix · 67), containing heavy metals should not exceed fifty millionths.
Abnormal toxicity of this product, salt acid (0.1mol / L; acid salt 20mg per 1ml) dissolved, add sterile saline solution per 1ml solution containing 2,000 units, according to inspection (Chinese Pharmacopoeia 1985 edition two Appendix 86), administered by intravenous injection, should be specified.
?Assay Weigh accurately the amount of goods, salt acid (0.1mol / L; acid salt 10mg per 1ml) to dissolve, then sterile water containing about 1ml each 1,000 units of the solution, according to antibiotic microbial test method for the determination (Chinese Pharmacopoeia 1985 edition two Appendix 95). 1,000 units of tetracycline hydrochloride equivalent to 1mg of C22H24N2O8 · HCl.
[The role and use antibiotic medicines. There are broad-spectrum antimicrobial effect. Mainly for rickettsial diseases, brucellosis, mycoplasma pneumonia, chlamydia, can also be used for sensitive gram-positive cocci and negative ?Usage and Dosage? 0.5g orally once a day 3 to 4 times.
Children over 8 years old per kg body weight daily 30 ~ 40mg, 3 to 4 times daily.
[Note] superinfection and long-term use can cause liver damage. Liver and kidney dysfunction, caution. Children under 8 years old and pregnant women, [Storage] Sealed or strict closure, shading, in a dry place. Valid for three years.
[Agents] (1) tetracycline tablets (2) tetracycline eye ointment (3) tetracycline ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? Preparation of TLC plates diatomite G amount, plus 10 times the amount of hydrochloric acid (6mol / L) boiled for 10 to 15 minutes, filtered, washed with water until the filtrate alkaline Congo red indicator VIS, and then with a 5-fold amount of acetone - ethyl acetate (5:1), dried, filtered, dried at 105 ?. Of dried celite 1.5g, plus sodium hydroxide solution (5mol / L) adjusted to pH 8.2 to 8.5 to 5% of ethylene diamine tetraacetic acid disodium salt solution 5ml, into a paste, the uniform coating on the 10 × 20cm glass plate at room temperature to no significant traces of water, dried for 1 hour at 105 ?, spare.

Source: http://www.ibc-tracker.com/download/20130720/Tetracycline.pdf

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