Molecular Mass: 340.28 Anhydrous substance

                             367.31 Crystalline water

Esculin

(pharmaceutical Ingredient)

Description

Esculin is a pharmaceutical ingredient that is used for the production of pharmaceutical products with venotonic, capillary-strengthening and antiphlogistic action. The drug is derived from a coumarin derivative that is extracted from the bark of flowering ash (Fraxinus ornus). This ingredient has a similar action to that of vitamin P and it is the best for the treatment of both internal and external hemorrhoids as well as varicose veins. Apart from this, Esculin is used in the diagnostic laboratories.

Molecular Mass: 340.28 Anhydrous substance

: 367.31 Crystalline water

Property - Value

Appearance - Crystalline powder

Color - White to light-creamy

Taste - Bitter

Odor - Odorless

Melting temperature (ºC) - Approximately 240.0 (with disintegration)

Successive melting temperatures (ºC) - 155.0; 204.0; 212.0

Solubility:

In water (20ºC): Poorly soluble

In alcohol (20ºC): Poorly soluble

In methanol (20ºC): Poorly soluble

In hot alcohol: Soluble

In hot methanol: Soluble

In hot pyridine: Soluble

In hot dioxane: Soluble

Moisture content according to K. Fisher (%) - 6.50 – 8.0

Sulfate ash (%): Not more than 0.1

Heavy metals content (%): Not more than 0.004

Limpidity of solution: Need not meet standard No 5

Specific rotation (º): (2% solution of anhydrous esculin (wt/v) in 50% dioxane solution) from -84.0 to -87.0

Extinction coefficient (µm): (0.0015% solution in methanol)from 0.340 to -0.360

Particle size (µm): Min 95.0 – 180.0

Esculin content calculated as dry substance: Not less than 98.0

Microbial content: Total microorganisms (number/g) not more than 10-3

Supplied: The substance is filled in double polyethylene bags of 25 kg and placed in cardboard barrels.

Quality: IX French Pharmacopoeia, DAB 10

Expiration Term: Four years

Physicochemical Indices of the Finished Product: 17Moulds and yeast (number/g)not more than (10 to the power of (-2) times 18) Enterobacteriaceae, Ps. aerguinosa, St. aureusnot allowed

The drug is a product of a coumarin derivative extracted from the bark of flowering ash (Fraxinus ornus).

Esculin substance is used for manufacturing pharmaceuticals with venotonic, capillary-strengthening and antiphlogistic action, with similar action to that of vitamin P. It is excellent for treatment of internal and external hemorrhoids and varicose veins. The Esculin is also used in the diagnostic laboratories.

Physicochemical Indices of the Finished Product

17Moulds and yeast (number/g)not more than (10 to the power of (-2) times 18) Enterobacteriaceae, Ps. aerguinosa, St. aureusnot allowed

Property      -   Value

Appearance - crystalline powder

Color            - white to light-creamy

Taste           - bitter

Odor            - odorless

Melting temperature (ºC) - approximately 240.0 (with disintegration)

Successive melting temperatures (ºC) - 155.0; 204.0; 212.0

Solubility

in water (20ºC)poorly soluble

in alcohol (20ºC)poorly soluble

in methanol (20ºC)poorly soluble

in hot alcohol  - soluble

in hot methanol - soluble

in hot pyridine- soluble

in hot dioxane - soluble

Moisture content according to K. Fisher (%) - 6.50 – 8.0

Sulfate ash (%)not more than 0.1

Heavy metals content (%)not more than 0.004

Limpidity of solution -  need not meet standard No 5

Specific rotation (º)
(2% solution of anhydrous esculin (wt/v) in 50% dioxane solution)from -84.0 to -87.0

Extinction coefficient (µm)
(0.0015% solution in methanol)from 0.340 to -0.360

Particle size (µm)min 95.0 – 180.0

Esculin content calculated as dry substance - not less than 98.0

Microbial content

Total microorganisms (number/g)not more than 10-3

Supplied

The substance is filled in double polyethylene bags of 25 kg and placed in cardboard barrels.

Quality

IX French Pharmacopoeia, DAB 10

Expiration Term

Four years