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AMOXICILLIN

SYNONYMS:

alpha-Amino-p-hydroxybenzylpenicillin; p-Hydroxyampicillin;
AMPC; Anemolin; Aspenil; Augmentin; Betamox;
Bristamox; Cabermox; Cemoxin; Cilamox;
Clamoxyl; Clamoxyl (Trihydrate); Cuxacillin;

 

 

CAS NO.:

26787-78-0 (Trihydrate)

 

EINECS NO.:

248-003-8

 

FORMULA:

C16H19N3O5S-3H2O

 

H.S. CODE:

3006

 

CLASS NO.:

N/A

 

UN NO.:

N/A

 

NFPA:

N/A

 

DESCRIPTION:

white to off-white crystalline powder.
AMPICILLIN is a semisynthetic antibiotic, a member of the penicillin family of antibiotics. To extend the usefulness of the penicillins to the treatment of infections caused by gram-negative rods, the broad-spectrum penicillins (ampicillin, amoxicillin, carbenicillin, and ticarcillin) were developed.  It is created by attaching acid radicals to the central structure of 6-aminopenicillanic acid. Chemically, it is D-(-)-6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7 -oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate.  Similar in action to penicillin G--the most widely used natural penicillin--ampicillin (or alpha-aminobenzylpenicillin) is more stable in stomach acids and therefore may be given orally; it is also more active against certain strains of bacteria.

 

APPLICATION

It is used regularly to treat common urinary-tract infections, some respiratory infections, and bacterial meningitis in children, although many strains of Hemophilus influenzae (the most common cause of bacterial meningitis) are now resistant to ampicillin, and it commonly is used along with other drugs. The potential side effects of ampicillin are similar to those of other penicillins--i.e., chiefly allergic reactions ranging from skin rashes and hives to life-threatening anaphylactic shock (very rare). People who are allergic to other drugs in this family are also likely to react to ampicillin. The incidence of skin rashes is higher with ampicillin than with other penicillins, a factor that suggests a possible toxic reaction, as well as a truly allergic response. AMOXICILLIN is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo- 4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. Amoxicillin is useful in treating urinary tract infections caused by gram-negative rods as well as in treating typhoid and enteric fevers.

SPECIFICATION & PACKING

APPEARANCE: White or Almost White Powder

IDENTIFICATION: Comply Test 

ASSAY: 98.0 - 100.5 % (on Anhydrous basis)

CLARITY OF SOLUTION: Complies test 

OPTICAL ROTATION: +290° - +315° 

HEAVY METALS: 20 ppm max

N,N-DIMETHYLANILINE: 20 ppm max

SULFATED ASH: 0.5% max

WATER: 11.50% - 14.50% 

PH: 3.5 - 5.5 (0.25% W/V Solution)

BULK DENSITY: 0.65 - 0.8 gr/ml (Compact Type)
Packing: 25kg/drum
Storage:
Seal and keep away from light.

RAW MATERIAL:

N/A

END GOODS:

SEE SPECIAL DESCRIPTION

REMARKS:

N/A

MATERIAL SAFE DATA SHEETS

1. CHEMICAL IDENTIFICATION AND COMPANY INFORMATION

PRODUCT NAME: Amoxicillin, Trihydrate, USP Grade

SYNONYMS: C16H19N3O5S-3H2O
CAS NO:
26787-78-0 (Trihydrate)


2. COMPOSITION/INFORMATION ON INGREDIENTS

Ingredient CAS Number Potency Hazardous

Amoxicillin, Trihydrate 61336-70-7 >900 mg/mg No exposure limits established by OSHA or ACGIH

3. PHYSICAL & CHEMICAL PROPERTIES

Product Description: Amoxicillin, Trihydrate, USP Grade

Formula: C16H19N3O5S•3H2O

Molecular Weight: 419.5

Storage Temperature: 2 to 6 C

pH (1.00 g/L): Under Development (3.5-5.5 suspected range)

Vapor Density: N/A

Melting Point: N/A

Specific Gravity: >0.19

Solubility: Partially soluble in water (May form a suspension)

Appearance: White to off-white powder

Odor: Odorless

4. HAZARDS IDENTIFICATION

Label Hazard Warnings: May cause sensitization by inhalation and skin contact.

Label Precautionary Statements: Do not breathe dust. Avoid contact with skin and eyes. Wear suitable protective clothing, gloves, and eye/face protection.

Laboratory Protective Equipment: Safety glasses, protective gloves, lab coat, and appropriate respirator

HMIS Rating:
Health      Flammability      Reactivity           Personal Protection Equipment

N/A              N/A                N/A                              N/A

NFPA Rating:

Health         Flammability           Reactivity              Special Hazards

N/A                  N/A                   N/A                            N/A

Storage and Handling Precautions: Store in a tightly sealed container in a cool, dry place. Do not breathe dust. Wash thoroughly after handling. Persons allergic to the penicillin family of chemicals should not handle this product.


5. POTENTIAL HEALTH HAZARDS/ TOXICOLOGICAL INFORMATION

RTECS Info listed is for the anhydrous form

Toxicity: LD50 (IPR-Rat)(mg/Kg): 2870

LD50 (IPR-Mouse)(mg/Kg): 3590

LD50 (Oral-Rat)(mg/Kg): >15000

Carcinogenicity: NTP: No

IARC: No

Z List: No

OSHA Reg: No

Effects of Overexposure: Nausea, vomiting, headaches, dizziness, gastrointestinal upset,

irritation, kidney damage, seizures, reproductive effects

Target Organs: None identified

Medical Conditions Aggravated By Exposure: If you are allergic to penicillins, do not handle this product

Routes of Entry: Ingestion, inhalation, skin and eye contact

The toxicological properties of t his product have not been thoroughly investigated

6. EMERGENCY AND FIRST AID

Route of Entry Symptoms First Aid Procedures

Ingestion May cause irritation if swallowed If swallowed, wash out mouth with water. Never give anything

by mouth to an unconscious person.

Get medical attention.

Inhalation May cause irritation to respiratory tract Safely remove victim to fresh air. If not breathing, institute cardiopulmonary resuscitation (CPR). If breathing is difficult, ensure clear airway and give oxygen.

Get medical attention.

Eye Contact Direct contact may cause irritation.

May cause redness, tearing, or blurred vision.

Flush immediately with large amounts of water for at least 15 minutes. Eyelids should be held away from the eyeball to ensure thorough rinsing.

Get medical attention if irritation persists.

Skin Contact Irritating. May cause reddening, itching or inflammation.

Wash area thoroughly with soap and water. Remove and wash contaminated clothing.

Get medical attention if irritation persists.

7. FIRE HAZARDS & FIRE FIGHTING MEASURES

Flash Point (Closed Cup): N/A

Flammable Limits: Upper – N/A % Lower – N/A %

Fire Extinguishing Media: Water spray, carbon dioxide, dry chemical powder, or appropriate foam. Use extinguishing media suitable for surrounding fire.

Special Fire-Fighting Procedures: In the event of a fire, wear full protective clothing and NIOSH approved selfcontained breathing apparatus. Evacuate the area and fight fire from a safe distance.

Unusual Fire & Explosion Hazards: May emit toxic fumes under fire conditions.

Toxic Gases Produced: Carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides


8. REACTIVITY & CONDITIONS TO AVOID

Stability: Stable

Hazardous Polymerization: Will not occur

Conditions to Avoid: Incompatibles

Incompatibles: Strong oxidizing agents

Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides

9. SPECIAL PRECAUTIONS/PROTECTIVE EQUIPMENT

Ventilation: Ventilation hood recommended

Respiratory Protection: A NIOSH/MSHA approved air purifying respirator is recommended where airborne concentrations are expected to exceed exposure limits. Protection provided by purifying

respirators is limited.

Eye/Skin Protection: Have eye-washing facilities readily available where eye contact can occur. Wear chemical safety goggles. Use appropriate chemical protective gloves when handling.

Showering and changing into street clothes after work is recommended.

10. SPILLS & LEAKS

Spill or Discharge: Wear suitable protective clothing and a self-contained breathing apparatus if available.

Carefully sweep up and remove. Place material in a dry container and cover. Remove

from the area. Flush spill area with water.

Disposal Procedure: Dispose in accordance with all applicable federal, state, and local environmental regulations.

EPA Hazardous Waste Number: N/A

11. TRASNPORTATION DATA

Domestic (D.O.T.): Proper Shipping Name: CHEMICALS, N.O.S. (NON-REGULATED)

Hazard Class: N/A

UN/NA: N/A

Labels: N/A

International (I.M.O.): Proper Shipping Name: CHEMICALS, N.O.S. (NON-REGULATED)

Hazard Class: N/A

UN/NA: N/A

Labels: N/A

12. REGULATORY INFORMATION

U.S. Federal Regulatory Information

TSCA: No

SARA TITLE III:

Section 302 (EHS) Ingredients: No

Section 313 Ingredients: No

Section 304 (EHS/CERCLA) Ingredients: No

SARA TITLE III NOTIFICATION INFORMATION

Acute Health Hazard: No

Chronic Health Hazard: No

Fire Hazard: No

Sudden Release of Pressure Hazard: No

International Regulatory Information

Risk Phrases: 42/43 – May cause sensitization by inhalation and skin contact

Safety Phrases: 22 – Do not breathe dust

24/25 – Avoid contact with skin and eyes

36/37/39 – Wear suitable protective clothing, gloves, and eye/face protection

SPECIAL DESCRIPTION

Members of ampicillin derivatives

Product

CAS RN

Ampicillin sodium

69-52-3

Ampicillin

69-53-4

Penicillin G benzathine

1538-09-6

Metampicillin

6489-97-0

Ampicillin trihydrate

7177-48-2

Broadcillin

8067-85-4

Pivampicillin hydrochloride

26309-95-5

Epicillin

26774-90-3

Amoxicillin Trihydrate

26787-78-0

Ampicillin benzathine

33276-75-4

Pivampicillin

33817-20-8

Amoxicillin sodium

34642-77-8

Bacampicillin hydrochloride

37661-08-8

Pivampicillin pamoate

39030-72-3

Talampicillin hydrochloride

39878-70-1

Pivampicillin probenate

42190-91-0

Talampicillin

47747-56-8

Bacampicillin

50972-17-3

Combipenix

51004-51-4

Ampicillinoic acid

57457-66-6

Amoxicillin Anhydrous

61336-70-7

N-(N'-Methylasparaginyl)amoxicillin

63329-59-9

Aspoxicillin

63358-49-6

N-Propionylampicillin

74226-27-0

Amoxicillin-potassium clavulanate combination

74469-00-4

Amoxicillin-clavulanic acid mixture

79198-29-1

Lenampicillin hydrochloride

80734-02-7

Lenampicillin

86273-18-9

Sulacillin

94935-63-4