Ceftiofur Hydrochloride Ketoprofen Injection

Characteristics: This product is suspension of fine particles, fine particle sinking after static position, shake to become a uniform milky white suspension.

Identification: (1) In a chromatogram recorded under the determination of content, the retention time of the major peak of the test solution corresponds to that of the reference solution of Ceftiofur Hydrochloride Ketoprofen Injection.

(2) Take the product 0.5ml，adding ethanol 1ml to dissolve, add two 4-dinitrophenylhydrazine TS 1ml, shake well, heating to boiling, then cooling, then produce a kind of orange-red precipitate.

Test (Sterility): 10 bottles of this product are taken as samples, take 10ml per bottle (shake well before use), after mixing, take 25ml, add aseptic 1% Twain -80 and 0.1% peptone solution 250ml, fully shake to disperse, then add the penicillin enzyme solution (about 14400IU penicillin enzyme per 1mg this product), fully shake for 30 minutes, take mixing liquid 10ml, add separately to fluid thioglycollate medium and Modified Martin Broth, 14 days of rocking bed culture under the corresponding conditions, inoculating culture medium on the slope culture medium, 2 days of bacterial culture and 3 days of fungal , in accordance with the rules, the results should be in accordance with the regulations culture.

Others: Should comply with the relevant provisions of the injections.

Assay of content

Ceftiofur Hydrochloride: Assay according to high performance liquid chromatography.

Test of chromatographic conditions and system applicability: Use octadecylsilane bonded silica gel as filler; the detection wavelength is 254nm. The degree of separation between the ceftiofur peak and the peak of the internal standard should be in accordance with the requirements.

Mobile phase preparation: Take 3.85g ammonium acetate, add four butyl hydroxide ammonium hydroxide solution(10→100)54ml, Add deionized water to 700ml, adjust pH value to 6.6 ~ 6.8 with glacial acetic acid, then add methanol 200ml and tetrahydrofuran 110ml, shake well.

Preparation of internal standard solution: Take the appropriate quantity of ethylparaben, add ammonium acetate solution（0.05mol／L）, to get a solution containing 50ug in each 1ml, shake well until dissolved.

Assay method: Take this product 5ml, precision weighing, put in a 25ml graduated flask, dissolving and diluting to scale with two methyl formamide - n-butanol (1:1), shake well, use precision instruments to weigh and take 1ml, add acetonitrile water (1:1) 10ml, N-hexane 5ml, oscillate and shake for 2 minutes, centrifugal, measuring and taking the lower layer solution 1ml with a precision instrument, then add internal standard solution 10ml, shake well, take 20ul into HPLC, recording chromatogram; take 25mg standard product of Ceftiofur Hydrochloride, precision weighing, put in a 25ml graduated flask, dissolving and diluting to scale with two methyl formamide - n-butanol (1:1) 2.5ml and acetonitrile water (1:1) , shake well, use precision instruments to weigh and take 1ml, then add internal standard solution 10ml, shake well, take 20ul into HPLC, recording chromatogram, calculation of peak area by internal standard method, and then take this product, measure relative density at the same time, convert the quantity of the sample into milliliter, then calculate.    

Ketoprofen: Assay according to high performance liquid chromatography.

Test of chromatographic conditions and system applicability：Use octadecylsilane bonded silica gel as filler, Use phosphate buffer liquid(take Potassium dihydrogen phosphate 6.8g, add water, dissolve and dilute to 100ml, use phosphoric acid to adjust the pH to 3.5 + 0.1) – acetonitrile - water （2：43：55）as mobile phase; the detection wavelength is 255nm. The number of theoretical plates is calculated according to the peak of ketoprofen，should not less than 2000.

Assay method: Weigh with a precision instrument and take the appropriate amount of the product, after the quantitative dilution of the mobile phase, prepare the solution per 1ml contains about 0.1mg of ketoprofen, weigh with precision instrument and take 10ul put into HPLC, recording chromatogram; then take the standard product of ketoprofen, assay with the same method, calculate the peak area by external standard method. Then take this product, measure relative density at the same time, convert the quantity of the sample into milliliter, then calculate. 

Indication: Same with Ceftiofur Hydrochloride Ketoprofen.

Dosage and Administration:  

Intramuscular injection

Cattle: Bacterial respiratory infections : 1 ml per 50 kg body weight for 3 - 5 days.

Acute interdigital necrobacillosis (panaritium, foot rot) : 1 ml per 50 kg body weight for 3 days.

Acute metritis (0 - 10 days post partum) : 1 ml per 50 kg body weight for 5 days.

Swine: Bacterial respiratory infections : 1 ml per 50 kg body weight for 3 days.