This product is a sodium salt of 4-amino-n - (6-chloro-3-pyridazinyl) benzenesulfonamide. Calculated
by an anhydrous compound, the content of c10h8cln4nao2s shall not be less than 99.0%.
Character:
This product is white to light yellow powder.It is dissolved in water, methanol, ethanol, and
chloroform.
Identification:
(1) take this product and sulfaclodazine sodium as a reference substance, dissolve them with
methanol and dilute them to make a solution containing about 10mg each in 1ml as test solution
and reference solution. According to the chromatographic conditions of related substances, draw 2
UL of each of the above two solutions and point them on the same silica gel gf254 thin layer plate.
The position and color of the main spots of the test solution should be the same as that of the
control solution.
(2) The infrared absorption spectrum of this product should be consistent with the control
spectrum.
(3) Identification reaction of aromatic first amines (sop-044)
Inspection:
The alkalinity of the product was 1.0g, dissolved in 20ml water, and determined according to the
law (sop-012). The pH value should be 7.2-9.2.
The clarity of the solution:
2.5G, add 50ml water to dissolve, and the solution should be clarified (sop-009).
Related substances:
Take this product and add methanol to make a solution containing 10mg of Sulfachloropyrazine
sodium per 1ml as the test solution; take the appropriate amount and dilute it with methanol to
make a solution containing 0.01mg and 0.03mg of Sulfachloropyrazine sodium per 1ml as the
reference solution 1 and 2. According to the test of thin layer chromatography, draw 4ul of each of
the above three solutions, respectively point them on the same silica gel gf254 thin layer plate,
develop them with toluene ethyl acetate methanol (3:1:1) as developing agent, and air them .If the
impurity spots appear in the test solution, the color of the single impurity spot shall not be deeper
than that of the main spot of reference solution 2, and the sum of the impurities shall not exceed
1.0%.
The moisture content:
It is determined according to the moisture determination method (sop-043, the first method), and
the moisture content should not exceed 5.0%.
Arsenic salt:
Take 1g arsenic salt, add 1.0g calcium hydroxide, mix, add a small amount of water, stir unevenly,
after drying, first use small fire to carbonize, then burn at 500 ~ 600 ºC to complete ashing, cool,
add 5ml hydrochloric acid and 23ml water to dissolve, according to the inspection (sop-044), should
meet the requirements (0.0002%).
Content determination:
Take about 0.5g of this product, weigh it accurately, add 30ml of water and hydrochloric acid
solution (1 → 2) to dissolve it, and titrate with sodium nitrite solution (0.1mol/l) according to the
perpetual stop titration (ws-006). Every 1ml of sodium nitrite solution (0.1mol/l) is equivalent to
30.67mg of c10h8cln4nao2s.
Function and use:
Sulfonamides.
Storage:
Keep out of light and sealed.
Retest period:
The first three months of validity.
Validity:
2 years
Standard source:
Chinese Veterinary Medicine Dictionary (2015 Edition)
Audited Supplier 
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