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Oral Pencillin Derivatives
Ampicillin Trihydrate
Ampicillin Anhydrous
Cloxacillin Sodium
Flucloxacillin Sodium

Type of Drug:
Semi Synthetic Pencillin Derivate

Therapeutic Action and Use:
Broad Spectrum Antibiotic / Antibacterial.

Preparations:
Amoxycillin Capsules,
Amoxicillin Oral Suspension,
Co-amoxiclav Tablets

Product Chemistry

Common Name: Amoxycillin Trihydrate

Chemical Name:
(2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.

Molecular Weight: 419.4

Molecular Formula: C16H19N3O4S,3H2O

Chemical Serail No: (CAS No.) 61336-70-7

Packing: 25Kg in double polythene bags in corrugated container

Storage: Store below 30�C

Shelf Life: 48 months

Specifications

Appearance: A white to almost white granules/powder.

Odor: Characteristic

* Optical Rotation: +290� to +315�

Water Contents: 11.5 to 14.5 % 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 1.0 % w/w

N,N-Dimethylaniline: Not more than 20 ppm

Related Substances:

i- Individual impurity: Not more than 1.0 %

ii- Total Impurities: Not more than 2.0 %

Contents:

* Amoxycillin (HPLC): 95.0 to 102.0 %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

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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

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

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

                                                                                                                     Back to Products




Type of Drug:
Semi Synthetic Pencillin Derivate

Therapeutic Action and Use:
Broad Spectrum Antibiotic / Antibacterial.

Preparations:
Ampicillin Capsules,
Ampicillin Oral Suspension

Product Chemistry

Common Name: Ampicillin Anhydrous

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: 349.4

Molecular Formula: C16H19N3O4S

Chemical Serail No: (CAS No.) 69-53-4

Packing: 25Kg in double polythene bags in corrugated container

Storage: Store below 30�C

Shelf Life: 48 months

Specifications

Appearance: A white granules/powder.

Odor: Characteristic

* Optical Rotation: +280� to +305�

Water Contents: Not more than 2.0 % w/w

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

pH Value: 3.5 to 5.0

Sulphated Ash: Not more than 0.5 % w/w

N,N-Dimethylaniline: Not more than 20 ppm

Related Substances:

i- Individual impurity: Not more than 1.0 %

ii- Total Impurities: Not more than 2.0 %

Contents

* Ampicillin (HPLC): 96.0 to 100.5 %w/w

Bulk Density(tapped):

i- Compacted: Not less than 0.65g/ml

ii- Powder: Not less than 0.30g/ml

*(Based on anhydrous substances)

Pharmacopeial Quality: USP, BP, EP

                                                                                                                     Back to Products





 
Type of Drug:
Semi Synthetic Pencillin Derivate

Therapeutic Action and Use:
Broad Spectrum Antibiotic / Antibacterial.

Preparations:
Cloxacillin Sodium Capsules,
Cloxacillin Sodium Oral Suspension

Product Chemistry

Common Name: Cloxacillin Sodium

Chemical Name:
Sodium (2S,5R,6R)-6-[[[3-(2-chlorophenyl)-5-methylisoxazol-4-yl]carbonyl] amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate

Molecular Weight: 475.9

Molecular Formula: C19H17CIN3NaO5S,H2O

Chemical Serail No: (CAS No.) 7081-44-9

Packing: 25Kg in double polythene bags in corrugated container

Storage: Store below 25�C

Shelf Life: 48 months

Specifications

Appearance: A white to almost white granules/powder.

Odor: Characteristic

* Optical Rotation: +160� to +169�

Water Contents: 3.0 to 4.5% w/w

Clarity of Solution: (Water): Not less than reference opalescence,

pH Value: 5.0 to 7.0

N,N-Dimethylaniline: Not more than 20 ppm

Related Substances:

i- Individual impurity: Not more than 1.0 %

ii- Total Impurities: Not more than 2.0 %

2-Ethylhexanoic Acid: Not more than 0.8% w/w

Contents

* Cloxacillin Sodium: 95 to 101% 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

                                                                                                                     Back to Products




Type of Drug:
Semi Synthetic Pencillin Derivate

Therapeutic Action and Use:
Broad Spectrum Antibiotic / Antibacterial.

Preparations:
Flucloxacillin Sodium Capsules,
Flucloxacillin Sodium Oral Suspension

Product Chemistry

Common Name: Flucloxacillin Sodium

Chemical Name:
Sodium (2S,5R,6R)-6-[[[3-(2-chloro-6-fluorophenyl)-5-methylisoxazol-4-yl] carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate

Molecular Weight: 493.9

Molecular Formula: C19H16CIFN3NaO5S,H2O

Chemical Serail No: (CAS No.) 1847-24-1

Packing: 25Kg in double polythene bags in corrugated container

Storage: Store below 25�C

Shelf Life: 48 months

Specifications

Appearance: A white to almost white granules/powder.

Odor: Characteristic

* Optical Rotation: +158� to +168�

Water Contents: 3.0 to 4.5% w/w

Clarity of Solution: (Water): Not less than reference opalescence,

pH Value: 5.0 to 7.0

N,N-Dimethylaniline: Not more than 20 ppm

Related Substances:

i- Individual impurity: Not more than 1.0 %

ii- Total Impurities: Not more than 2.0 %

2-Ethylhexanoic Acid: Not more than 0.8% w/w

Contents

* Cloxacillin Sodium: 95 to 101% 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

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