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Ampicillin Sodium Sterile Crystalline USP/EP

Synonyms

d-(−)-α-aminobenzylpenicillin sodium salt, ampicillin sodium salt

Technical Data

CAS Number: 69-52-3
Molecular Formula: C16H18N3NaO4S
Molecular Weight: 371.39
Beilstein Registry Number: 4119211
EC Number: 200-708-1

Ampicillin Sodium Sterile Crystalline (EP Grade)

ITEMSSPECIFICATIONS
DescriptionA white or almost white powder, hygroscopic
SolubilityFreely soluble in water, practically insoluble in acetone, fatty oils and liquid paraffin.
Identification (IR)The IR spectrum should be concordant with that of Ampicillin trihydrate working standard.
Identification (TLC)The principal spot in the chromatogram obtained with the test solution should be similar in position, color and size to the principal spot in the chromatogram obtained with the reference solution (a)
Test for PenicillinsA dark yellow color should develop
Test for SodiumA dense, white precipitate should form, indicating the presence of sodium
Appearance of Solution (10% w/v solution)
Clarity
(1.0 g of sample dissolved in 10 ml of 1 M Hydrochloric acid or 10 ml of water)
Not more opalescent than reference suspension-II.
Absorbance at 430 nm
(1.0 g of sample dissolved in 10 ml of water)
NMT 0.15
pH
(10%w/v in carbon dioxide-free water)
8.0 to 10.0
Specific Optical Rotation
(0.25g of substance in 100 ml 0.4% w/v solution of potassium hydrogen phthalate, at 25°C)
Between +258° and +287° (Calculated on anhydrous basis)
Ampicillin Dimer
(by HPLC, %w/w)
NMT 4.5%
Any Individual Impurity
(by HPLC, %w/w)
NMT 2.0%
Methylene Chloride
(by GC, %w/w)
NMT 0.2%
Heavy MetalsNMT 20 ppm
Water
(by KF, %w/w, determined on 0.300g)
NMT 2.0%
SterilityShould be sterile
Bacterial Endotoxins
(IU/mg of Ampicillin)
NMT 0.15 IU/mg
Assay (by HPLC, % w/w)
As Ampicillin Sodium
(calculated on anhydrous basis)
91.0% - 102.0%
Residual Solvents:NMT 410 ppm
Acetonitrile (by GC)NMT 1.0 ppm
Sodium Thiocyanate
(by UV, w/w)
Particulate Matter
(particles per gram)
Visual InspectionShould be free from visible particles
Particulate Matter
(by LBPC)
a) ≥ 10 µ
b) ≥ 25 µ


NMT 6,000/g
NMT 600/g
Untapped DensityReport Only
Tapped DensityReport Only
* Note: Limits and tests for “Dimethylaniline” and “2-Ethylhexanoic acid” have not been included in the Specifications, as these are not used in the process of Ampicillin Sodium Sterile preparation. Product complies as per EP and IH specification. *

Ampicillin Sodium Sterile Crystalline (USP Grade)

ITEMSSPECIFICATIONS
DescriptionWhite to off-white, odorless or practically odorless, crystalline powder; hygroscopic.
Solubilitychloride and dextrose solutions.
Identification
a) by IR
The IR spectrum should be concordant with that of Ampicillin sodium working standard.
b) Test for SodiumA dense, white precipitate should form, indicating presence of sodium ions.
CrystallinityThe particles should show birefringence and exhibit extinction positions.
pH
(1% w/v in carbon dioxide-free water)
8.0 to 10.0
Water (K.F.)NMT 2.0% w/w
Sterility TestShould be Sterile
Bacterial EndotoxinsNMT 0.15 USP EU/mg
Assay (HPLC)
(calculated on anhydrous basis)
845 μg/mg to 988 μg/mg
Particulate MatterShould be free from visible particles
Particulate Matter
(by LBPC)
a) ≥ 10 µ
b) ≥ 25 µ

NMT 6,000/g
NMT 600/g
Untapped DensityReport Only
Tapped DensityReport Only
Residual Solvents
(by GC)
Acetonitrile
Methylene chloride

NMT 410 ppm
NMT 2000 ppm
* Limits and tests for “Dimethylaniline” and “2-Ethylhexanoic Acid” have not been included in the specifications, as these are not used in the manufacturing process of Ampicillin Sodium Sterile *

Molecular Structure

ampicillin-sodium-sterile-crystalline-usp-ep-structure

About

This product is used to select for ampicillin resistance in mutated and transformed cells. This is a ß-lactam antibiotic that inhibits bacterial cell-wall synthesis by inactivating transpeptidases on the inner surface of the bacterial cell membrane.

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