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Sterile Cephalosporin Derivatives
Ceftriaxone Sodium
Cephradine L. Arginine Blended
Type of Drug:
Semi Synthetic Cephalosporin Derivate

Therapeutic Action and Use:
Broad Spectrum Antibiotic / Antibacterial.

Preparations:
Cefotaxime Injection

Product Chemistry

Common Name: Cefotaxime Sodium

Chemical Name:
Sodium(6R,7R)-3-[(acetyloxy)methyl]-7-[[(Z)-2-(2-aminothiazol-4-yl)-2- (methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

Molecular Weight: 477.4

Molecular Formula: C16H16N5NaO7S2

Chemical Serail No: (CAS No.) 64485-93-4

Packing: 10Kg in Sterile, air tight, temper proof Aluminium container

Storage: Store below 25�C. Protect from light and moisture.

Shelf Life: 36 months

Specifications

Appearance: A white to slightly yellow hygroscopic powder

Odor: Characteristic

* Optical Rotation: +58� to +64�

Water Contents: Not more than 3.0 % w/w.

pH Value: 4.5 to 6.5

N,N-Dimethylaniline: Not more than 20 ppm

Related Substances:

i- Individual impurity: Not more than 1.0%

ii- Total Impurities: Not more than 3.0%

Sterility: Meet the requirements

Bacterial Endotoxins: Not more than 0.05 IU / mg

2-Ethylhexanoic acid: Not more than 0.5% w/w

Contents

* Cefotaxime Sodium: 96 to 102 % w/w

Bulk Density(tapped): Not less than 0.35g/ml

*(Based on anhydrous substances)

Pharmacopeial Quality: USP, BP, EP

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Type of Drug:
Semi Synthetic Cephalosporin Derivate

Therapeutic Action and Use:
Broad Spectrum Antibiotic / Antibacterial.

Preparations:
Ceftriaxone Injection

Product Chemistry

Common Name: Ceftriaxone Sodium

Chemical Name:
Disodium(6R,7R)-7-[[(Z)-(2-aminothiazol-4-yl)(methoxyimino)acetyl]amino]-3- [[(2-methyl-6-oxido-5-oxo-2,5-dihydro-1,2,4-triazin-3-yl)sulphanyl]methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

Molecular Weight: 662

Molecular Formula: C18H16N8Na2O7S3,3 1/2 H2O

Chemical Serail No: (CAS No.) 104376-79-6

Packing: 10Kg in Sterile, air tight, temper proof Aluminium container

Storage: Store below 25�C. Protect from light.

Shelf Life: 36 months

Specifications

Appearance: A white to slightly yellowish, crystalline powder

Odor: Characteristic

* Optical Rotation: -155� to -170�

Water Contents: 8.0 to 11.0 % w/w.

pH Value: 6.0 to 8.0

N,N-Dimethylaniline: Not more than 20 ppm

Related Substances:

i- Individual impurity: Not more than 1.0%

ii- Total Impurities: Not more than 4.0%

Sterility: Meet the requirements

Bacterial Endotoxins: Not more than 0.08 IU / mg

Contents

* Ceftriaxone Sodium: 96 to 102 % w/w

Bulk Density(tapped): Not less than 0.35g/ml

*(Based on anhydrous substances)

Pharmacopeial Quality: USP, BP, EP

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Type of Drug:
Semi Synthetic Cephalosporin Derivate

Therapeutic Action and Use:
Broad Spectrum Antibiotic / Antibacterial.

Preparations:
Cephradine Injection

Product Chemistry

Common Name: Cephradine Sterile with L-arginine blended

Chemical Name:
(6R,7R)-7-[[(2R)-2-amino-2-(cyclohexa-1,4-dienyl)acetyl]amino]-3-methyl- 8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

Molecular Weight: 349.4

Molecular Formula: C16H19N3O4S

Packing: 10Kg in Sterile, air tight, temper proof Aluminium container

Storage: Store below 2 - 8�C. Protect from light.

Shelf Life: 36 months

Specifications

Appearance: A white to off-white crystalline powder

Odor: Characteristic

* Optical Rotation: -155� to -170�

Water Contents: Not more than 4.0 % w/w.

pH Value: 8.0 to 9.0

Sulphated Ash: Not more than 0.2 % w/w

N,N-Dimethylaniline: Not more than 20 ppm

Related Substances:

i- Individual impurity: Not more than 0.25%

ii- Total Impurities: Not more than 2.0%

Sterility: Meet the requirements (free from microbes)

Bacterial Endotoxins: Not more than 0.20 EU / mg

Contents

* Potency (Cephradine + Cephalexin)(HPLC): Not less than 64%w/w

* Cephalexin (HPLC): Not more than 3.0 % w/w

* L-Arginine: Not more than 36.0 % w/w

Bulk Density(tapped): Not less than 0.40g/ml

*(Based on anhydrous substances)

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