- PRODUCT NAME:Amoxicillin com/micro
Amoxicillin is an antibiotic medication belonging to the penicillin class, commonly used to treat a wide range of bacterial infections. It is available in various formulations, including tablets, capsules, oral suspensions, and powder for reconstitution. This widely prescribed antibiotic is an essential tool in combating bacterial infections and is used in both children and adults.
The active ingredient in Amoxicillin works by inhibiting the growth and reproduction of bacteria. It achieves this by interfering with the synthesis of the bacterial cell wall, weakening the microorganisms and eventually leading to their destruction by the body's immune system.
This versatile medication is effective in treating various infections, such as respiratory tract infections (e.g., sinusitis, bronchitis), skin infections, urinary tract infections (UTIs), ear infections, and certain dental infections. Additionally, Amoxicillin is used in combination with other drugs to treat more severe infections caused by bacteria.
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Name of Product |
Amoxicillin Trihydrate Micronized |
Batch No. |
XQ2104054 |
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Net Weight |
100.00kg |
Packing |
25.00kg/drum |
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Mfg .Date |
2021-04-21 |
Expiry Date |
2025-03 |
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Date of Report |
2021-04-27 |
Specifications |
BP + In-house standard |
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TESTS |
SPECIFICATIONS |
RESULTS |
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1.Description |
White or almost white crystalline |
White crystalline powder |
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2.Solubility |
powder Slightly soluble in water, very slightly soluble in ethanol (96 per cent), practically insoluble in fatty oils. It
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3.Identification |
dissolves in dilute acids and dilute solutions of alkali hydroxides. IR:The spectrum of the sample corresponds to that of CRS. TLC: The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a). Chemical test: A dark yellow colour develops.
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Conforms |
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4.Appearance of solution(in HCI/NH₄OH) |
Not more opalescent than reference suspension Ⅱ |
Conforms |
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5.pH |
3.5-5.5 |
5.0 |
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6.Specific optical rotation |
+290°~+315° |
+306° |
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7.Water |
11.5%-14.5% |
13.0% |
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8.Assay(anhydrous) |
95.0%-102.0% |
99.4% |
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9.Related substances |
Any impurity:≤1.0% |
0.07% |
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10.Residual solvents |
N,N-Dimethylaniline:≤20ppm Acetone:≤0.5% |
(Not used in process) |
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11.Sulfated ash |
Methanol:≤0.3% ≤1.0% |
0.008% 0.040% |
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12.Particle size |
d(90) |
15.9μm |
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CONCLUSION:The results conform with BP + In-house standard. |
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