Amoxicillin and Ampicillin Trihydrate

Our Products

PENICILLIN ANTIBIOTICS

Penicillins are a class of beta-lactam antibiotics. Penicillin was the first antibiotic discovered from the mould Penicillium notatum in 1928 by Alexander Fleming at St. Mary’s Hospital in London, England.

The basic structure of penicillins is a nucleus consisting of a beta-lactam ring (4 membered cyclic amide) and a side chain. The beta-lactam ring is necessary for antibacterial activity, and the side chain determines the antibacterial spectrum and pharmacologic properties.

Various penicillins differ mainly by the structure of the side chain. In addition to their structural differences, the penicillins differ in their antimicrobial spectrum, pattern of β-lactamase resistance (susceptibility to penicillinase), the ability to penetrate the outer membrane of gram-negative bacteria, stability to gastric acids, and their behavior within the body.

Penicillins are generally bactericidal, inhibiting formation of the cell wall. Penicillins are used to treat skin infections, dental infections, ear infections, respiratory tract infections, urinary tract infections, gonorrhea.

There are different types of Penicillin Antibiotic products:

  • Amoxicillin Trihydrate
  • Ampicillin Trihydrate

Specifications

Amoxicillin Trihydrate

 Test Parameter   Specifications (in house)

Amoxicillin Trihydrate

Specifications (in house)

Ampicillin Trihydrate

Appearance White or almost white crystalline powder White crystalline powder
Identification By IR, HPLC &Chemically By IR, HPLC & Chemically
Crystallinity Crystalline Crystalline
Solubility Slightly  soluble in water, Slightly  soluble in water,
pH (0.2% sol. in water, w/v) 4.0-5.0 4.0-5.0
Clarity of solution HCl
10% sol. in 0.5 M HCl (w/v)
NMT reference suspension II NMT reference suspension II
Clarity of solution NH3
10% sol. in dil. NH3 solution (w/v)
NMT reference suspension II NMT reference suspension II
Water (Karl Fischer, w/w) 11.5 – 14.5% NMT 12.0-15.0%
Sulphated Ash,w/w NMT 1.0% NMT 0.5%
Specific Optical Rotation

(0.2% solution in water)

290°-315° 280-305°
N,N- Dimethyl Aniline Not Tested Not Tested
Heavy Metals NMT 20 ppm NMT 20 PPM
Assay Anhydrous Basis(HPLC %) NLT 98% or NLT 980 μg/mg NLT 98.5% or NLT 985 µg/mg
Any Individual impurity NMT 1.0% NMT 1.0%
Total Impurities NMT 2.0% NMT 2.0%
RESIDUAL SOLVENTS
Isopropyl alcohol NMT 2000 ppm NMT 2000 ppm
Methanol NMT 2000 ppm NMT 2000 ppm

Confirmation:

  • We certify that the above mentioned product is in conformity with the specifications of IP, BP , USP & EP.
  • N,N’- Dimethylaniline, Triethylamine, Dichloromethane and Pivalic acid are not used in the  manufacturing process.
  • The product tested according to the IP,BP, USP & EP.

Storage Conditions:

  • Preserve in well closed (air tight) containers, in a dry place, at a temperature not exceeding 25°C.

Packing:

  • Material packed in double liner poly bags and further packed in HDPE/Fiber board drums.

Amoxicillin/Ampicillin is a penicillin antibiotic that fights bacteria.

Amoxicillin is used to treat many different types of infection caused by bacteria, such as tonsillitis, bronchitis, pneumonia, gonorrhea, and infections of the ear, nose, throat, skin, or urinary tract.

Amoxicillin is also sometimes used together with another antibiotic called clarithromycin (Biaxin) to treat stomach ulcers caused by Helicobacter pylori infection. This combination is sometimes used with a stomach acid reducer called lansoprazole (Prevacid).

Amoxicillin/Ampicillin,  is an antibiotic useful for the treatment of a number of bacterial infections.[3] It is the first line treatment for middle ear infections. It may also be used for strep throat, pneumonia, skin infections, and urinary tract infections among others. It is taken by mouth, or less commonly by injection.

Common side effects include nausea and rash. It may also increase the risk of yeast infections and, when used in combination with clavulanic acid, diarrhea. It should not be used in those who are allergic to penicillin. While usable in those with kidney problems, the dose may need to be decreased. Its use in pregnancy and breastfeeding does not appear to be harmful.

Amoxicillin was discovered in 1958 and came into medical use in 1972. It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system. It is one of the most commonly prescribed antibiotics in children. Amoxicillin is available as a generic medication.

Names“Amoxicillin”/”Ampicillin”  is the INN, BAN, and USAN, while “Amoxycillin”/”Ampicillin”  is the AAN.

Amoxicillin/Ampicillin is one of the semisynthetic penicillins discovered by Beecham scientists.