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NEOMYCIN SULFATE

SYNONYMS:

Neobiotic; Otobiotic. Mycifradin sulfate; O-2,6-diamino-2,6-dideoxy-.beta.-L-
idopyranosyl-(1.->3)-O-.beta.-D-ribofuranosyl-(1->5)]-O-
[2,6-diamino-2,6-dideoxy-.alpha.-D-glucopyranosyl-(1->4)]-
2-deoxy sulfate

 

 

CAS NO.:

1405-10-3

 

EINECS NO.:

215-773-1

 

FORMULA:

C23H52N6O25S3

 

H.S. CODE:

29419000

 

CLASS NO.:

N/A

 

UN NO.:

N/A

 

NFPA:

2-1-0-E

 

DESCRIPTION:

Neomycin sulfate is a white to yellowish powder; hygroscopic; very soluble in water; slightly soluble in alcohol; insoluble in acetone.
Neomycin is an aminoglycoside antibiotic derived from the metabolic Streptomyces fradiae, effective against a wide range of aerobic gram-negative bacilli and some gram-positive bacteria. It consists of three components A, B, and C. The main form is B, The chemical designation is 2-Deoxy-4-O-(2,6-diamino-2,6-dideoxy-alpha-D-glucopyranosyl)-5-O-(3-O- (2,6-diamino-2,6-dideoxy- beta-L-idopyranosyl)-bete-D-ribofuranosyl)-D-streptamine.

 

APPLICATION

Neomycin is applied topically to the skin, conjunctiva, and ears in the treatment of infections due to susceptible organisms. It is used in combination with other antibiotics or antiinflammatory steroids. Neomycin sulfate is administered orally in preoperative bowel preparation.
Neomycin and Framycetin are not absorbed from the gastrointestinal tract and are thusfound in many topical medications such as creams, ointments and eyedrops. They can also be used for gastrointestinal infections. Framycetin yields neamine and neobiosamine B on hydrolysis.

SPECIFICATION & PACKING

APPEARANCE: white to yellowish powder

ASSAY: 680 μm/mg min (Anhydrous potency)

IDENTIFICATION: positive  (Test A, Test B,)

SULFATE: 27.0 - 31.0%

STREPTOMYCIN B: 3.0% max

pH: 5.0 - 7.0

RELATED SUBSTANCES: Neomycin C: 3.0 - 15.0%

Neamine : 2.0% max

Total Impurity: 15.0% max

LOSS ON DRYING: 8.0% max

OPTICAL ROTATION: +53.5º  ~ +59.0º

SULFATED ASH: 1.0% max

RESIDUE ON IGNITION: 1.0% max
Packing: 25KG/DRUM

Storage: Keep container dry. Keep in a cool place. Ground all equipment containing material. Keep container tightly closed. Keep in a cool, well-ventilated place. Combustible materials should be stored away from extreme heat and away from strong oxidizing agents.

RAW MATERIAL:

N/A

END GOODS:

N/A

REMARKS:

N/A

MATERIAL SAFE DATA SHEETS

Section 1: Chemical Product and Company Identification

Product Name: Neomycin sulfate

CAS#: 1405-10-3

Synonym:

Chemical Name: Not available.

Chemical Formula: C23H52N6O25S3


Section 2: Composition and Information on Ingredients

Composition:

Name               CAS #                % by Weight

Neomycin sulfate    1405-10-3                  100

Toxicological Data on Ingredients: Neomycin sulfate LD50: Not available. LC50: Not available.

Section 3: Hazards Identification

Potential Acute Health Effects:

Very hazardous in case of ingestion. Hazardous in case of eye contact (irritant), of inhalation. Slightly hazardous in case of skin contact (irritant, permeator).

Potential Chronic Health Effects:

CARCINOGENIC EFFECTS: Not available.

MUTAGENIC EFFECTS: Not available.

TERATOGENIC EFFECTS: Not available.

DEVELOPMENTAL TOXICITY: Not available.

Repeated or prolonged exposure is not known to aggravate medical condition.

Section 4: First Aid Measures

Eye Contact: Check for and remove any contact lenses. Do not use an eye ointment. Seek medical attention.

Skin Contact:

After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin.

Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated

clothing before reusing.

Serious Skin Contact: Not available.

Inhalation: Allow the victim to rest in a well ventilated area. Seek immediate medical attention.

Serious Inhalation: Not available.

Ingestion:

Do not induce vomiting. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not

breathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: May be combustible at high temperature.

Auto-Ignition Temperature: Not available.

Flash Points: Not available.

Flammable Limits: Not available.

Products of Combustion: These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...), sulfur oxides (SO2,SO3...).

Fire Hazards in Presence of Various Substances: Not available.

Explosion Hazards in Presence of Various Substances:

Risks of explosion of the product in presence of mechanical impact: Not available.

Risks of explosion of the product in presence of static discharge: Not available.

Fire Fighting Media and Instructions:

SMALL FIRE: Use DRY chemical powder.

LARGE FIRE: Use water spray, fog or foam. Do not use water jet.

Special Remarks on Fire Hazards: Not available.

Special Remarks on Explosion Hazards: Not available.

Section 6: Accidental Release Measures

Small Spill:

Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by

spreading water on the contaminated surface and dispose of according to local and regional authority

requirements.

Large Spill:

Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate through the sanitary system.

 

Section 7: Handling and Storage

Precautions:

Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the

residue under a fume hood. Ground all equipment containing material. Do not breathe dust. Avoid contact with eyes Wear suitable protective clothing In case of insufficient ventilation, wear suitable respiratory equipment If you feel unwell, seek medical attention and show the label when possible.

Storage:

Keep container dry. Keep in a cool place. Ground all equipment containing material. Keep container tightly

closed. Keep in a cool, well-ventilated place. Combustible materials should be stored away from extreme heat

and away from strong oxidizing agents.

Section 8: Exposure Controls/Personal Protection

Engineering Controls:

Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below

recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.

Personal Protection:

Splash goggles. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent.

Gloves.

Personal Protection in Case of a Large Spill:

Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product.

Exposure Limits: Not available.

Section 9: Physical and Chemical Properties

Physical state and appearance: Solid.

Odor: Not available.

Taste: Not available.

Molecular Weight: 908.87 g/mole

Color: Not available.

pH (1% soln/water): Not available.

Boiling Point: Not available.

Melting Point: Decomposes.

Critical Temperature: Not available.

Specific Gravity: Not available.

Vapor Pressure: Not applicable.

Vapor Density: Not available.

Volatility: Not available.

Odor Threshold: Not available.

Water/Oil Dist. Coeff.: Not available.

Ionicity (in Water): Not available.

Dispersion Properties: Not available.

Solubility: Not available.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Not available.

Incompatibility with various substances: Not available.

Corrosivity: Non-corrosive in presence of glass.

Special Remarks on Reactivity: Not available.

Special Remarks on Corrosivity: Not available.

Polymerization: No.

Section 11: Toxicological Information

Routes of Entry: Eye contact. Inhalation. Ingestion.

Toxicity to Animals:

LD50: Not available.

LC50: Not available.

Chronic Effects on Humans: Not available.

Other Toxic Effects on Humans:

Very hazardous in case of ingestion.

Hazardous in case of inhalation.

Slightly hazardous in case of skin contact (irritant, permeator).

Special Remarks on Toxicity to Animals: Not available.

Special Remarks on Chronic Effects on Humans: Excreted in maternal milk in animal.

Special Remarks on other Toxic Effects on Humans: Not available.

Section 12: Ecological Information

Ecotoxicity: Not available.

BOD5 and COD: Not available.

Products of Biodegradation:

Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The products of degradation are more toxic.

Special Remarks on the Products of Biodegradation: Not available.


Section 13: Disposal Considerations

Waste Disposal:

Section 14: Transport Information

DOT Classification: Not a DOT controlled material (United States).

Identification: Not applicable.

Special Provisions for Transport: Not applicable.

Section 15: Other Regulatory Information

Federal and State Regulations:

California prop. 65: This product contains the following ingredients for which the State of California has found to cause cancer, birth defects or other reproductive harm, which would require a warning under the statute:

Neomycin sulfate

California prop. 65: This product contains the following ingredients for which the State of California has found to cause birth defects which would require a warning under the statute: Neomycin sulfate

TSCA 8(b) inventory: Neomycin sulfate

Other Regulations: Not available..

Other Classifications:

WHMIS (Canada): CLASS D-2B: Material causing other toxic effects (TOXIC).

DSCL (EEC): R36- Irritating to eyes.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 1

Reactivity: 0

Personal Protection: E

National Fire Protection Association (U.S.A.):

Health: 2

Flammability: 1

Reactivity: 0

Specific hazard:

Protective Equipment:

Gloves.

Lab coat.

Dust respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respirator

when ventilation is inadequate. Splash goggles.


Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

SPECIAL DESCRIPTION

Aminoglycoside is any of a group of antibiotics derived from various species of Streptomyces or Micromonosporaceae, while some of which are produced synthetically. Aminoglycosides inhibit bacterial protein synthesis by binding with the 30S ribosomal subunit. They include;

 

 

Aminoglycoside antibiotic

CAS RN.

Adechlorin

96328-17-5

Gentamicin

1403-66-3

Netilmicin

56391-56-1

Gentamicin sulfate

1405-41-0

Amikacin

37517-28-5

Apramycin

37321-09-8

Butirosin sulfate anhydrous

51022-98-1

Chlorothricin

34707-92-1

Dibekacin

34493-98-6

Dihydrostreptomycin Sulfate

5490-27-7

Framycetin

119-04-0

Geneticin

49863-47-0

Hygromycin A

6379-56-2

Hygromycin B

31282-04-9

Isepamicin

58152-03-7

Kanamycin

59-01-8

Nebramycin

11048-13-8

Neomycin

1404-04-2

O-Demethylchlorothricin

134637-04-0

O-Demethylhydroxychlorothricin

134615-17-1

Paromomycin

7542-37-2

Puromycin

53-79-2

Ribostamycin

25546-65-0

Sisomicin

32385-11-8

Streptomycin

57-92-1

Streptozocin

18883-66-4

Tobramycin sulfate

49842-07-1

Tobramycin

32986-56-4

Neomycin analogues or derivatives;

Product

CAS RN.

Neomycin C

66-86-4

Framycetin

119-04-0

Fradicin

1403-61-8

Neomycin

1404-04-2

Bacitracin

1405-87-4

Neomycin sulfate

1405-10-3

Neomycin, hydrochloride

1406-02-6

Neomycin undecylenate

1406-04-8

Streptonigrin

3930-19-6

Neamine

3947-65-7

Paromomycin

7542-37-2

Predni aquos opthiole

8024-67-7

Cortisporin

8024-64-4

Synalar N

8025-20-5

Nebacetin

8025-63-6

Cicatrin

8055-43-4

Mixture (neomycin, polymyxin, bacitracin)

8057-37-2

Neoterramycin

8057-00-9

Proctosedyl

8058-05-7

Vibrocil

8059-14-1

Pimafucort

8072-88-6

Hexasalicylideneneomycin

11041-92-2

Neomycin B hydrochloride

25389-99-5

Ribostamycin

25546-65-0

Neomycin B sulfate

28002-70-2

3'-O-Methylneamine

37085-86-2

4'-O-Methylneamine

37085-87-3

1-N-(s)-4-Amino-2-hydroxybutyryl-3'4'-deoxyneamine

42859-94-9

Butirosamine

50474-68-5

Mixture (neomycin, polymyxin)

51273-62-2

Statrol

51484-67-4

Neomycin F

51795-47-2

Polyspectrin

52218-57-2

Diaropect

52503-65-8

Betnovate-N

53262-69-4

Neomycin B-glucoside

53861-54-4

L-N(sup 1)-(4-Amino-2-hydroxybutyryl)-4'-deoxyneomycin A

54333-80-1

4'-Deoxy-5-O-xylosylneamine

54333-81-2

Neomycin palmitate

55298-68-5

Ribosylparomamine

55781-25-4

Dodeca-N-methylneomycin hexamethochloride

57270-93-6

Dimethylaminopropylneomycin

57285-81-1

Tresaderm

57571-74-1

Kanamycin phosphotransferase II

58943-39-8

Neomycin C hydrochloride

63121-20-0

Neomycin 4,4'-methylenebis(3-hydroxy-2-naphthalenecarboxylic acid

71750-54-4

Cysto-myacyne

76391-80-5

Dontisolon

76403-99-1

Framycort

77536-65-3

Neomycin-pantothenate

78149-94-7

Vineomycin A1

78164-00-8

neomedrol-veriderm

78232-14-1

Neo-medrol

78232-16-3

Oterna

78371-70-7

Pulpomixine

78515-94-3

6'''-Deamino-6'''-hydroxyparomomycin I

78524-72-8

6'''-Deamino-6'''-hydroxyneomycin B

78524-73-9

Maxitrol

78666-15-6

Mixture(neomycin, nystatin, polymyxin, acetarsol, dimethicone)

78891-94-8

Sofradex

79173-16-3

3',4'-dideoxyparomomycin

80451-74-7

Vineomycin B2

80928-52-5

Vineomycin B1

81457-63-8

Vineomycin A2

81457-62-7

Trofodermin

84057-92-1

Dansylparomomycin

85166-09-2

Neotil

85883-86-9

Panotile

99401-18-0

3-N-methylparomomycin I

106288-50-0

Polyspectran OS

117733-87-6

Mixture(colistin sulfate, neomycin sulfate, hydrocortisone acetate, thonzonium bromide)

119509-48-7

(11beta)-11,17,21-Trihydroxypregn-4-ene-3,20-dione neomycin sulfate / polymyxin sulfate

123354-95-0

Fokalmin

126663-41-0

Dexapolyspectran

143305-95-7