Product Detail

Ampicillin Trihydrate

Type of Drug:

Semi Synthetic Pencillin Derivate

Therapeutic Action and Use:

Broad Spectrum Antibiotic / Antibacterial.

Preparations:

Ampicillin Capsules,
Ampicillin Oral Suspension,
Ampicillin Tablets

Product Chemistry

Common Name:

Ampicillin Trihydrate

Chemical 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.

Molecular Weight:

403.5

Molecular Formula:

C₁₆H₁₉N₃O₄S,3H₂O

Chemical Serail No:

(CAS No.) 7117-48-2

Packing:

25Kg in double polythene bags in corrugated container

Storage:

Store below 30°C

Shelf Life:

48 months

Related Substances:

i- Individual impurity:

Not more than 1.0 %

ii- Total Impurities:

Not more than 2.0 %

Contents:

* Ampicillin (HPLC):

95.0 to 100.5 %w/w

Bulk Density(tapped):

i- Compacted:

Not less than 0.65g/ml

ii- Powder:

Not less than 0.35g/ml
*(Based on anhydrous substances)

Pharmacopeial Quality:

USP, BP, EP

SPECIFICATIONS

Appearance:

A white granules/powder.

Odor:

Characteristic

* Optical Rotation:

+280° to +305°

Water Contents:

12.0 to 15.0 % w/w

Clarity of Solution:

(Hydrochloric Acid): Not less than reference opalescence, (Ammonia): Not less than reference opalescence.

pH Value:

3.5 to 5.5

Sulphated Ash:

Not more than 0.5 % w/w

N,N-Dimethylaniline:

Not more than 20 ppm