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Amoxicillin and Clavulanate Potassium 4: 1 CAS No 61177 -45-5

China Amoxicillin and Clavulanate Potassium 4: 1 CAS No 61177-45-5, Find details about China Clavulanate Potassium, Amoxicillin and Clavulanate Potassium (4: 1) from Amoxicillin and Clavulanate Potassium 4: 1 CAS No 61177-45-5

Model NO.
SAMREAL-0197
Specifications
Ep, Enterprise Standard
Trademark
samreal
Specification
20kg/drum
Origin
China
Model NO.
SAMREAL-0197
Specifications
Ep, Enterprise Standard
Trademark
samreal
Specification
20kg/drum
Origin
China

Amoxicillin and Clavulanate Potassium 4: 1 CAS No 61177-45-5
Amoxicillin and Clavulanate Potassium 4: 1 CAS No 61177-45-5
Amoxicillin and Clavulanate Potassium 4: 1 CAS No 61177-45-5
Amoxicillin and Clavulanate Potassium 4: 1 CAS No 61177-45-5
Name of productAmoxicillin and Clavulanate postassium(4:1)
Tests Specifications Results
CharactersA white to slightly yellow powder .hygroscopicA white powder , hygroscopic
IdentificationThe retention time of the two major peak in the chromatogram of the Assay preparation corresponds to that exhibited in the chromatogram of the standard preparation.Conforms
Water9.0% ~12.0%10.2%
PH3.5~7.55.3
Related substancesAny impurity ≤2.0% (calculated on the basis of amoxicillin peak areas in the chromatogram of reference solution)0.03%
Total impurities ≤5.0% (calculated on the basis of amoxicillin peak areas in the chromatogram of reference solution)0.06%
AssayAmoxicillin(C16 H19 N3 O5S)≥695 μg/mg,Amoxicillin 772 μg/mg
Clavulanic acid(C8 H9 NO5) ≥ 176μg/mg,Clavulanic acid 193 μg/mg
The ratio of Amoxicillin to Clavulanic acid should be 3.6~ 4.44.0
 
Name of productAmoxicillin and Clavulanate postassium(7:1)
If you need 7:1, please contact our customer service
 
Name of productClavulanate Potassium-Microcrystalline Cellulose(1:1)
Tests Specifications Results
AppearanceWhite or almost white powder, hygroscopicAlmost white powder, hygroscopic
Identification(l)HPLC: positivePositive
(2) Reaction (b) of potassium: positivePositive
(3) Reaction of cellulose: positivePositive
pH4.8 - 8.05.7
Polymeric impurities and other impurities absorbing at 278 nmNMT 0.400.033
WaterNMT2.5%0.46%
Related substancesImpurity E: NMT 1.0%0.014%
Impurity G: NMT 1.0%0.0017%
Any other single impurity (major): NMT 0.10%<0.05%
Total impurities: NMT 2.0%0.016%
Assay (HPLC)91.2% ~107.1% (as content of potassium clavulanate stated on the label)100.4%
CLAV.ACID(as is)38.3%~45.0%42.1%
CLAV. POT. (as is)45.6%~53.5%50.2%
ConclusionConforms to the requirements of EP.
 
Name of productClavulanate Potassium-Silicon Dioxide(1:1)
Tests Specifications Results
AppearanceA white or almost white powder, hygroscopicA  white powder, hygroscopic
Identification(1) The principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with reference solution (a).Conforms
(2)lt gives reaction (b) of potassium.Conforms
(3) It gives the reaction of silicatesConforms
PH4.8 ~8.05.1
Absorbance≤0.40(278nm)0.064
Related substancesImpurity E≤1.0%0.09%
Impurity G≤1.0%<Reporting      threshold limit0.05%
Any other impurity ≤ 0.2%<Reporting      threshold limit0.05%
Total impurities≤ 2.0%0.09%
water≤2.5%0.53%
Residual SolventsAcetone≤5000ppm48ppm
1-butanol≤5000ppm909ppm
AssayIt contains Potassium Clavulanate(C8H8KNO5)48.0%~53.5%,calculated on the anhydrous basis.49.9%
ConclusionThe results conform with EP and Enterprise standard.

Amoxicillin and Clavulanate Potassium 4: 1 CAS No 61177-45-5
Amoxicillin and Clavulanate Potassium 4: 1 CAS No 61177-45-5

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