AMOXICILIN TRIHYDRATE

COMPACTED POWDER

MW: 419.46

-CAS –REGISTERED NO: 61336 – 70 -7

MOLECULAR FORMULA: C₁₆H₁₉N₃O₅S, 3H₂O

CHEMICAL NAME:

(2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-

azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.

CATEGORAY:

Semi-synthetic broad spectrum Penicillin.

SPECIFICATION:

- Description: white, practically odorless crystalline Powder

- Odor: almost odorless

- Specific optical rotation: +290 to +315

- pH: Between 3.5 – 5.5

- Water content (Karl Fischer Test): Between 11.5 % and 14.5% (w/w)

- Dichloromethan: N.M.T. 600 ppm

- Sulfated Ash: N.M.T. 1%

- Heavy metal: N.M.T. 20 ppm

- Tapped density: N.L.T 0.7 g/ml

- Assay: N.L.T. 95.0% and N.M.T. 100.5% of Amoxicillin as anhydrous base

PACKAGING: 1*25kg double polyethylene bags in each carton box

STORAGE: Preserve in tight containers, and store at controlled room temperature

SHELF LIFE: 48 months

PHARMACOPOEIAL QUALITY: USP, BP

REMARKS: N,N-Dimethyl Anilline and Benzene are not used or generated during the process.

The Referred Material Complies With BP, EP & USP