AMPICILLIN TRIHYDRATE - COMPACTED POWDER


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AMPICILLIN TRIHYDRATE

COMPACTED POWDER

FOR ORAL ADMINISTRATION

MW: 403.46

-CAS –REGISTERED NO: 7177-48-2

MOLECULAR FORMULA: C16 H19 N3 O4 S, 3H2O

CHEMIDAL NAME:

(2S,5R,6R)-6-[[(2R)-2-Amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.

CATEGORAY:

Semi-synthetic broad spectrum Penicillin.

SPECIFICATION:

- Description: white, practically odorless crystalline Powder

- Odor: almost odorless

- Specific optical rotation: +280 to +305

- pH: Between 3.5 and 5.5

- Water content (Karl Fischer Test): Between 12.0 % and 15.0%

- Dichloromethan: N.M.T. 600 ppm

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

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

- Assay: N.L.T. 96.0% 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 container store below 25ºC and dry place

SHELF LIFE: 48 months

PHARMACOPOEIAL QUALITY: USP, BP

REMARKS: N-N-Dimethyl Aniline is not used or generated during the process.

The Referred Material Complies With BP, EP & USP