MATERIAL SAFETY DATA SHEET

 

1. Identification of the substance/preparation and company

 

Identification of the manufacturer

 

Biotika a.s.

 

976 13 Slovenska Lupca 566

 

Slovak Republic

 

Telephone number: +421 48 4368 111

 

Identification of the product

1.1. Trade name:

Penicillin V Potassium
Phenoxymethylpenicillin Potassium

1.2. Chemical name:

4-Thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-[(phenoxyacetyl)amino]-,monopotassium salt, [2S-(2a,5a,6b)]-.
Monopotassium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phen-oxyacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate[132-98-9].

1.3. Chemical family:

Antibiotic

1.4. Formula:

C16H17KN2O5S

1.5. CAS No.:

132-98-9

 

2 Composition/information on ingredients

Penicillin V Potassium only

 

3 Hazards identification

Non toxic, LD50 cannot be expressed, allergen, allergic reactions may occur in 2 - 5 % of the population.

 

4 First-aid measures

4.1. Eye contact:

rinse out with water

4.2. Skin contact:

rinse out with water

4.3. Inhalation:

immediately see a doctor

4.4. Ingestion:

see a doctor

4.5. Emergency first aid procedures:

apply adrenalin, noradrenalin, hydrocortisone, anti-histaminic agents, calcium

 

5 Fire-fighting measures

5.1. Flammable limits:

settled powder    410°C

 

spun powder       580°C

5.2. Extinguishing media:

CO2, water

 

6 Accidental release measures

6.1. Respiratory protection:

prevent from excessive pulverization

6.2. Ventilation:

common aeration

6.3. Skin protection:

protective gloves

6.4. Eye protection:

yes

 

7 Handling and storage

7.1. Storage precautions:

keep in dry place, protected from light and moisture

7.2. Storage temperature:

between +10°C to +25°C

 

8 Exposure controls/personal protection

8.1. Threshold limit value:

Penicillin V Potassium is harmless per os by usual dose of 400 000 units every 4 hours (7 - 10 days)

8.2. Effect of overexposure:

In ultra sensitive humans: allergic reactions from urticaria to anaphylactic shock

8.3. Respiratory protection:

prevent from excessive pulverization

8.4. Ventilation:

common aeration

8.5. Skin protection:

protective gloves

8.6. Eye protection:

yes

 

9 Physical and chemical properties

9.1. Appearance/state at 20°C:

a white crystalline powder

9.2. Odor:

a slight characteristic of penicillin

9.3. Specific gravity:

0.40 - 0.45

9.4. Molecular weight:

388.48

9.5. pH:

4.0 - 7.5

9.6. Solubility in water:

freely soluble

9.7.Solubility in organic solvent:

practically insoluble in ether, fatty oils and liquid paraffin

 

10 Stability and reactivity

10.1. Stability:

stable under common storage conditions

10.2. Material to avoid:

stable under common storage conditions

10.3. Incompatibility:

milk, milk products, cyclamates

10.4. Hazardous polymerization:

 

Conditions to avoid:

Penicillin V formed complexes in solutions with sucrose. In neutral and alkaline solutions with sucrose was reaction with the formation of sucrose-penicilloate esters. These might be antigenic

 

11 Toxicological information

Non toxic

 

12 Ecological information

There is no supposed effect on any ecosystem from those substances released as a consequence of normal production.

 

13 Disposal consideration

13.1. In case that material is released or spilled:

remove by usual means (sweep away, use vacuum cleaner, etc.

13.2. Waste disposal method

burn down

 

14 Transport information

Keep container closed and protect it from damage.

 

15 Regulatory information

Non toxic, allergen, non-explosive, flammable limits:

settled powder

410°C

spun powder

580°C

Extinguishing media:

CO2, water

 

16 Other information

Recommended uses:

Penicillin is contraindicated at patients known to be hypersensitive to Penicillin and it should be used with caution at patients with known histories of allergy. It is not recommended for chronic, severe or deep seated infections.

 

On medical prescription only!

 

 

Sources of information:

USP 31

 

Ph.Eur. 6th

 

Company specification