7/30/2019 Pradeep Report Matter

1/4

Pharmaceutical emulsions. They may also be used as solubilizing agents for a variety

of substances including essential oils and oil-soluble vitamins, and as wetting agents

in the formulation of oral and potential suspensions. They have been found to be

useful in improving the oral bioavailability of molecules that are substrates for p-

glycoprotein1

7. Description: Polysorbates have a characteristic odor and a warm, somewhat

bitter taste. Their colors and physical forms at 25C although it should be

noted that the absolute color intensity of the products may vary from batch to

batch and form manufacturer to manufacturer.

8. Typical Properties:

Acidity/alkalinity: PH = 6.0-8.0 for 5%w/v aqueous solution.

Flash point: 149C

9. Stability and Storage Conditions: Polysorbates are stable to electrolytes and

weak acids and bases; gradual specification occurs with strong acids and

bases. The oleic acid esters are sensitive to oxidation. Polysorbates are

hygroscopic and should be examined for water content prior to use and dried if

necessary. Also, in common with other polyoxyethylene surfactants,

prolonged storage can lead to the formation of peroxides.

Polysorbates should be stored in a well-closed container, protected from light,

in a cool, dry place.

10. Incompatibilities: Discoloration and/or precipitation occur with various

substances, especially phenols, tannins, tars, and tarlike materials. The

antimicrobial activity of paraben preservatives is reduced in the presence of

Polysorbates.

11. Safety: Polysorbates are widely used in cosmetics food products, and oral,

parentereal, and topical pharmaceutical formulations and are generallyregarded as nontoxic and nonirritant materials. Ther have, however, been

occasional reports of hypersensitivity to Polysorbates following their topical

and intermuscular use.3 polysorbates have also been associated with serious

adverse effects, including some deaths, in low-birthweight infants

intravenously administered a vitamin E preparation containing a mixture of

Polysorbates 20 and 80. when heated decomposition, the poplysorbates emit

acrid smoke and irritating fumes.

12. The WHO has set an estimated acceptable daily intake for Polysorbates 20,

40,, 60, 65, and 80, calculated as total polysorbate esters, at up to 25 mg/kg

body- weight. 6

5.4 SORBTAN ESTER 52,54,56, (span 80)

1. Nonproprietary Names:

BP: Sorbitan laurate

Ph EUR: Sorbitani lauras

USPNF: Sorbitan monoaurate (sorbitan, esters monodecanoate)

Sorbitan monooleate.

2. Synonyms: Ablunol S- 80, Arlacel 80, Span 80.

3. Chemical Names and CAS Registry Numbers: (Z) Sorbitan mono-9-octadecenoate

[1338-43-8].

4. Empirical Formula and Molecular Weight: C24H44O6, 429

5. Structural Formula:

7/30/2019 Pradeep Report Matter

2/4

R1= R2 = OH, R3 = R (see below) for sorbitan monoesters

R1 = OH, R2 = R3 = R for sorbitan diesters

R1 = R2 = R3 = R for sorbitan trimesters

7/30/2019 Pradeep Report Matter

3/4

Density: 1.01

Flash point:> 149C

HLB value: 4.3

Hydroxyl value: 193-209

Saponification value: 149-160

Solubility: sorbitan esters are generally soluble or dispersible in oils; they are alsosoluble in most organic solvents. In water, although insoluble, they are generally

dispersible.

Surface tension: 30

Viscosity (dynamic): 970-1080

10. Stability and Storage Conditions

Gradual soap formation occurs with strong acids or bases; sorbitan esters are stable in

weak acids or based.

Sorbitan esters should stored in a well-closed container in a cool, dry place.

Sorbitan esters are widely used in cosmetics, food products, and oral and topical

pharmaceutical formulations and are genereally regarded as nontoxic and nonirritant

materials. However, there have been occasional reports of hypersensitive skinreactions following the topical application of products containing sorbitan esters.

When heated to decomposition, the sorbitan esters emit acrid smoke and irritating

fumes.

The WHO has set an estimated acceptable daily intake of sorbitan monopalmitate,

monostereate , and tristearate, and of sorbitan monolaurate and monooleate at up to 25

mg/kg body-weight calculated as total sorbitan esters.

7/30/2019 Pradeep Report Matter

4/4

5.5. ALCOHOL107,31,92

1. Nonproprietary Names:

BP: Ethanol (96%)

JP: Ethanol

Ph Eur: Ethanolum (96 per centum)

USP: Alcohol2. Synonyms: Ethyl alcohol; ethyl hydroxide; grain alcohol; methyl carbinol.

3. Chemical Name and CAS Registry Number: Ethanol [64-17-5]

4. Empirical Formula and Molecular Weight: C2H6O46.07

5. Structural Formula:

6. Functional Category: Antimicrobial preservative; disinfectant; skin penetrant;

solvent.-

7. Applications in Pharmaceutical Formulation or Technology: Ethanol and aqueous

ethanol solutions of various concentrations are widely used in pharmaceuticalformulations and cosmetics. Although ethanol is primarily used as a solvent, it is also

employed in solutions as an antimicrobial preservative. Topical ethanol solutions are

also used as penetration enhancers and as disinfectants. Ethanol has also been used in

transdermal preparations in combination with Labrasol as a co- surfactant.

8. Description: In the BP 2004, the term ethanol used without other qualification

refers to ethanol containing > 99.5% v/v of C2H6O. the term alcohol, without other

qualification, refers ethanol 95.1-96.9% v/v. where other strengths are intended, the

term alcohol or ethanol is used, followed by the statement of the strength.