Amoxicillin/ potassium clavulanate 4:1

Specification: BP/USP

Product Name Amoxicillin/ potassium clavulanate 4:1
Quality Standard Internal standard


Testing Items Critrion
Characteristics White or off white  powder
Identification Same retention time with standard reference
Melting Point 258℃
PH 4.8-8.6
Water ≤11.0%
Assay Amoxicillin ≥71.0%
Assay Glavulanate ≥17.0%
Relative substance individual ≤2.0%
Relative substance total ≤5.0%
Weight ratio between two substances 3.6-4.4
Glavulanate potassium part analysis USP Standard
Identification a) Positive by HPLC b) Reaction of potassium
Water(KF.) ≤1.5%
PH 5.5-8.0
Related substance(HPLC) ≤2.0%
Clavam-2-carboxylate potassium ≤0.01%
Methanol (GC) ≤0.1%
Tert-Butylamine GC ≤0.2%
ASSAY CLAV.(a.b) 75.5-92.0%


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