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Povidone

Test Specification...BP
Characters It occurs as white or yellowish-white, hygroscopic powder or flakes.
Identification Test (A) Test (B) Test (C) Test (D) (a) Infrared absorption spectrophotometry (b) Specified Test. A pink color is produced. (c) Specified Test. A red color is produced. (e) Specified Test. The substance dissolves.
Solubility Freely soluble in water, in ethanol (96 %) and in methanol, very slightly soluble in acetone.
Appearance of solution Solution is clear and not more intensely colored than reference solution B6, BY6 or R6
pH Between 3.0 to 5.0
Aldehydes Not more than 500ppm, expressed as acetaldehyde.
Peroxides Not more than 400 ppm, expressed as H2O2.
Formic acid Not more than 0.5%
Hydrazine Not more than 1ppm
Impurity A Not more than 10 ppm.
Impurity B Not more than 3.0%
Water Not more than 5.0%
Sulfated Ash Not more than 0.1%
Assay Not less than 11.5% and not more than 12.8% of Nitrogen (anhydrous basis)
Test Specification...FCC
Characters It occurs as a White or yellowish-white, hygroscopic powder or flakes.
Identification Test A Test B a. Infrared absorption spectrophotometry b. Specified test. The substance dissolves.
Solubility Freely soluble in water, in ethanol (96 per cent) and in methanol, very slightly soluble in acetone.
Appearance of solution Solution S is clear and not more intensely coloured than reference solution B6, BY6 or R6
pH 3.0 to 5.0
Viscosity, expressed as K-value The K-value of povidone having a stated K-value or a stated K-value range with an average of more than 15 is 90.0 % to 108.0 % of the stated value or of the average of the stated range.
Aldehydes Maximum 500 ppm, expressed as acetaldehyde.
Peroxides Maximum 400 ppm
Formic acid Maximum 0.5%
Hydrazine Maximum 1ppm
Impurity A Maximum 10ppm
Impurity B Maximum 3.0%
Water Maximum 5.0%
Sulphated Ash Maximum 0.1%
Assay Not less than 11.5% not more than 12.8% of Nitrogen
Test Specification...USP
Characters It occurs as a white to slightly creamy white powder, hygroscopic.
Identification Test A Test B Test C Test D Test E a. Infrared Absorption b. Specified test. An orange-yellow precipitate is formed c. Specified test. A pale blue precipitate is formed d. Specified test. A deep red color is produced e. Specified test. The substance dissolves
Solubility Freely soluble in water, in methanol, and in alcohol; slightly soluble in acetone; practically insoluble in ether
Residue on Ignition Not more than 0.1%
Lead Not more than 10 ppm
Limit of Aldehydes Not more than 0.05%
Limit of Hydrazine Not more than 1 ppm of hydrazine.
Vinylpyrrolidinone Not more than 0.001%
2-Pyrrolidone Not more than 3.0%
Peroxides Not more than 0.35, corresponding to not more than 400 ppm, expressed as H2O2
Formic acid Not more than 0.5%
pH 3.0–5.0 for Povidone having a nominal K-value of 30 or less
Water Not more than 5.0 %
K-Value K-value of Povidone having a stated K-value or a stated K-value range with an average of more than 15: 90.0%–108.0% of the stated value or of the average of the stated range
Residual solvents Meets the requirements
Assay (Nitrogen Determination Method) Not less than 11.5% and not more than 12.8% on the 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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