Sodium Picosulfate BP USP NF IP Reagent FCC Food Grade Manufacturers Exporters
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Sodium Picosulfate

Test Specification...BP
Description It occurs as a white or almost white, crystalline powder.
Identification

Test (A)

Test(B)

Test(C)

Test(D)

a. Infrared absorption Spectrophotometry.

b. Thin- layer chromatography

c. Specified test. A white precipitate is formed.

d. The solution gives reaction of sodium.

Solubility Freely soluble in water, slightly soluble in ethanol (96%)
Appearance of Solution The solution S is clear and not more intensely colored than reference solution GY7
Acidity or alkalinity Specified test.
Related substance-

1.Correction factors

2.Impurities A, B

3.Unspecified impurities

4.Total

1. Impurity A=0.7; Impurity B=0.5

2. Not more than 0.2%

3. Not more than 0.10%

4. Not more than 0.5%

Chlorides Not more than 200ppm
Sulfates Not more than400ppm
Water Between 3.0% to 5.0%
Assay Not less than 98.5% to not more than 100.5 % (anhydrous substance).
Test Specification...USP
Description It occurs as a white or almost white, crystalline powder.
Identification

Test A

Test B

a. Infrared Absorption

b. The solution gives reaction of sodium.

Solubility Freely soluble in water, slightly soluble in alcohol
Color of Solution TheSample solutionis not more intensely colored than theStandard solution.
Acidity or alkalinity Specified test.
Related substance-

1. 4,4′-[(Pyridin-2-yl)methylene] bisphenol

2. 4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]phenylsodium sulfate (sodiumpicosulfaterelated compound A)

3.Any other individual impurity

4.Total impurities

1. Not more than 0.2%

2. Not more than 0.2%

3. Not more than 0.10%

4. Not more than 0.5%

Chlorides Not more than 0.02%
Sulfates Not more than0.04%
Water determination Between 3.0% to 5.0%
Residual solvents Meets the requirements
Assay Not less than 98.5% to not more than 100.5 % calculated on anhydrous basis

Shelf life, Storage and Packing
It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.

Other
GLP, cGMP (FDA) Approved, ISO 9001, ISO 14001, ISO 45001, ISO 17025, ISO 22000, FSSC 22000, FSSAI, Halal and Kosher certified.
We observe WHO Good manufacturing practice and Good laboratory practice.

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