Amoxicillin Trihydrate Compacted CAS No 61336-70-7 Amoxicillin

• Function: Antibiotic and Antimicrobial Agents
• Certification: GMP
• Grade Standard: Medicine Grade
• Type: API
• State: Powder
• Volatile: Not Volatile
• Model NO.: SAMREAL-0196
• Mf: C16h25n3o8s
• Specificatons: USP and Enterprise Standard
• Transport Package: Drum
• Specification: 25kg/drum
• Trademark: samreal
• Origin: China

Product Description

Name of Product	Amoxicillin Trihydrate Compacted	Packing	25Kg/Drum
Tests	Specification		Results
Description	White, practically odorless, crystalline powder		conforms
Identification	The IR spectrum obtained with the substance to be examined should correspond with that obtained with USP Amoxicillin RS. The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the Assay.		conforms
Crystallinity	Show birefringence and extinction positions		conforms
pH	3.5 ~6.0		4.9
Water	11.5% ~14.5%		12.8%
Dimethylaniline	≤20ppm		Not detected
Organic impurities
Impurity I^a	≤1.0%		Not detected
Impurity D^b	≤1.0%		Not detected
Impurity D^c	≤1.0%		0.08%
Impurity A^d	≤0.5%		Not detected
Impurity G^g	≤1.0%		Not detected
Impurity E^h	≤1.0%		Not detected
Impurity E^i	≤1.0%		Not detected
Impurity M^j	≤1.0%		Not detected
Impurity C^l	≤1.0%		Not detected
Impurity J^m	≤1.0%		0.21%
Impurity L^n	≤1.0%		Not detected
Any unspecified individual impurity	≤1.0%		0.05%
Total impurities	≤5.0%		0.38%
Assay	900 ~1050μg/mg (C16H19N3O5S) calculated on the anhydrous basis		1003μg/mg
Bulk density			0.6288g/ml
Tapped density			0.7702g/ml
Particle size ≥850μm 850μm~180μm ≤180μm			0% 86% 14%
Note: Dimethylaniline is not used in the manufacturing process of this product and is not detectable in final products. It complies with USP.