Sr no test observation limits 1 description "white to off white, fine granular powder" "white to off white, fine granular powder" 2 solubility sightly soluble in ethanol 95% sightly soluble in ethanol 95% 3 identification complies "the maxima obtained in sample preparation & standard preparation exhibits on 284 nm" 4 loss no drying 2.51% not more than 3.0% 5 assay 50.66% not less than 49.0% on dried basis.

Decription ( Characteristic)Clear , colourless, syrupy liquid Miacible with water and alcoholClear , colourless, syrupy liquid Miacible with water and alcohol2(A.) HPLC ChromatogramCompliesAs per test(B) Optical Rotation+1.60+1.50 to +3.50(C.) Clarity @ 25 CCompliesClear syrupy liquid @ 25C3Appearance Of SolutionCompliesThe solution is clear & colourless4Condutivity4.00 S.cm-1Not more than 10S.cm-1 at temp of 20C5LeadComplies0.5 ppm (max)6NickelComplies1.0 ppm (max)7Redusing Sugar13.16 mlNot less than 12.8 ml of 0.05 M Sodium Thiosulphate8Redusing Sugar After Hydrolysis11.04 mlNot less than 8.0 ml of 0.05 M Sodium Thiosulphate9Water29.7028.0 to 32.0 %10Assay ( as D - Glucitol or D - Sorbitol)88.8172.0 to 92.0 % (on dried basis)11Total Viable Count50 cfugm max500 cfugm max12Total Fungal Count30 cfugm max150 cfugm max13E.ColiAbsentAbsentgm14SalmonellaAbsentAbsentgm

Description Bulky white powder, odorless CompliesSolubility Practically insoulble in water and in ethanol (95%). It dissolved in dilute acids. CompliesIdentification The resulting solution gives reaction A of magnesium salt CompliesColour of solution Solution A is not more intensely coloured than reference solution BS3. CompliesArsenic Not more than 4 ppm CompliesHeavy Meals Not more than 30 ppm CompliesChloride Not more than 0.1% CompliesSulphate Not more than 0.5% CompliesIron Not more than 0.08% CompliesSoluble Substance Not more than 1.0% Complies"Substance Insolube In Acetic Acid" Not more than 0.1% CompliesCalcium Not more than 1.5% CompliesLoss on Ignition Between 30.0 to 32.5% 31.33%Assay Between 95.0 to 100.5% of Mg(OH)2 96.28%

Description Yellowish-brown to reddish brown, amorphous powder, having a slight, characteristic odor. Its solution is acid to litmus. Reddish-brown, amorphous powder, having a slight, characterstic odor. Its solution is acid to litmusSolubility Soluble in water and in alcohol, practically insoluble in chloroform, in carbon tetrachloride, in either, in solvent hexane, and in acetone. Soluble in water and in alcohol, practically insoluble in chloroform, in carbon tetrachloride, in either, in solvent hexane, and in acetone.Identification A. A Deep blue color is produced Complies the testB. A brown, dy, nonsmearing film is formed, and it dissolved readily in water. Complies the testHeavy Metals Limit Max. 20 ppm 0.5 ppmIodine (on dried basis) Not more than 6.6% 3.36%Loss on Drying Not more than 8.0% ww 3.06%Nitrogen (on dried basis) 9.5-11.50% 10.80%Sulphated Ash Not more than 0.20% 0.010%Assay (Available iodine on dried basis) 9.00%-12% ww 10.76%

AppearanceWhite to creamish flakesWhite2ColourWhite to creamishWhite3Average molecular weight6000 - 701265654pH (5% in aqu. soln.)4.5 - 7.54.715Moisture1.0% Max0.31%6Hydroxyl Value (mgKOHgm)16 - 1817.09

Description White or almost white crystalline powder or colourless crystals CompliesSolubility Free soluble in ethanol (95 per cent). In either and in methol; very slightly soluble in water CompliesIdentification IR A) Melting Point 125 C to 128 C 126 CB) By IR Infrared absorption spectrophgotometry : Positive PositiveC) TLC Chromatogram Spot : to Comply CompliesAppearance of solution Solution should be clear & not more intensely coloured than BYS6 solution CompliesAcidity NMT 0.1 ML OF 0.1 N NaOH Required to change the colour of the indicator to blue 0.08ml of 0.1M NaOH RequiredRelated Substance 1) Impurity NMT 05% 0.36%2) Unspecified Impurities NMT 0.5% 0.15%3) Total Impurities NMT 1.0% 0.28%Sulphated Ash NMT 0.1% 0.078%Assay By HPLC 98.0% to 102.0% 98.1%

Appearance White to faintly yellowish powder Almost white crystalineSolubility Freely soluble in anhydrous formic acid. Very Slightly soluble in Ether and Methylene chloride. Practically Insoluble in Alcohol and In water. CompliesIdentification A) IR IR Spectrum concordant with reference working standard CompliesB) By TLC The Rf Value of the principal spot observed in the chromatogram of the test solution corresponds to that of the principal spot in Std Solution CompliesResidue On Ignition NMT 0.2% 0.05%Chromatographic Purity (By TLC) NMT 0.5% CompliesLoss On Drying NMT 0.5% 0.30%Assay (On Dried Basis) By Titration 98.00% to 102.0% 99.02%

AppearanceCompliesWhite or yellowish white powderCompliesA. IRCompliesB. The substance dissolves3pH (1.0g in 20.0ml)3.63.0 7.04Water3.8%5.0%5Vinylpyrrolidinone0.02%0.2%6K-Value29.725.0 34.0

Sr no test observation limits 1 description "white to off white, fine granular powder" "white to off white, fine granular powder" 2 solubility sightly soluble in ethanol 95% sightly soluble in ethanol 95% 3 identification complies "the maxima obtained in sample preparation & standard preparation exhibits on 284 nm" 4 loss no drying 2.51% not more than 3.0% 5 assay 50.66% not less than 49.0% on dried basis.

Decription ( Characteristic)Clear , colourless, syrupy liquid Miacible with water and alcoholClear , colourless, syrupy liquid Miacible with water and alcohol2(A.) HPLC ChromatogramCompliesAs per test(B) Optical Rotation+1.60+1.50 to +3.50(C.) Clarity @ 25 CCompliesClear syrupy liquid @ 25C3Appearance Of SolutionCompliesThe solution is clear & colourless4Condutivity4.00 S.cm-1Not more than 10S.cm-1 at temp of 20C5LeadComplies0.5 ppm (max)6NickelComplies1.0 ppm (max)7Redusing Sugar13.16 mlNot less than 12.8 ml of 0.05 M Sodium Thiosulphate8Redusing Sugar After Hydrolysis11.04 mlNot less than 8.0 ml of 0.05 M Sodium Thiosulphate9Water29.7028.0 to 32.0 %10Assay ( as D - Glucitol or D - Sorbitol)88.8172.0 to 92.0 % (on dried basis)11Total Viable Count50 cfugm max500 cfugm max12Total Fungal Count30 cfugm max150 cfugm max13E.ColiAbsentAbsentgm14SalmonellaAbsentAbsentgm

Description Bulky white powder, odorless CompliesSolubility Practically insoulble in water and in ethanol (95%). It dissolved in dilute acids. CompliesIdentification The resulting solution gives reaction A of magnesium salt CompliesColour of solution Solution A is not more intensely coloured than reference solution BS3. CompliesArsenic Not more than 4 ppm CompliesHeavy Meals Not more than 30 ppm CompliesChloride Not more than 0.1% CompliesSulphate Not more than 0.5% CompliesIron Not more than 0.08% CompliesSoluble Substance Not more than 1.0% Complies"Substance Insolube In Acetic Acid" Not more than 0.1% CompliesCalcium Not more than 1.5% CompliesLoss on Ignition Between 30.0 to 32.5% 31.33%Assay Between 95.0 to 100.5% of Mg(OH)2 96.28%

Description Yellowish-brown to reddish brown, amorphous powder, having a slight, characteristic odor. Its solution is acid to litmus. Reddish-brown, amorphous powder, having a slight, characterstic odor. Its solution is acid to litmusSolubility Soluble in water and in alcohol, practically insoluble in chloroform, in carbon tetrachloride, in either, in solvent hexane, and in acetone. Soluble in water and in alcohol, practically insoluble in chloroform, in carbon tetrachloride, in either, in solvent hexane, and in acetone.Identification A. A Deep blue color is produced Complies the testB. A brown, dy, nonsmearing film is formed, and it dissolved readily in water. Complies the testHeavy Metals Limit Max. 20 ppm 0.5 ppmIodine (on dried basis) Not more than 6.6% 3.36%Loss on Drying Not more than 8.0% ww 3.06%Nitrogen (on dried basis) 9.5-11.50% 10.80%Sulphated Ash Not more than 0.20% 0.010%Assay (Available iodine on dried basis) 9.00%-12% ww 10.76%

AppearanceWhite to creamish flakesWhite2ColourWhite to creamishWhite3Average molecular weight6000 - 701265654pH (5% in aqu. soln.)4.5 - 7.54.715Moisture1.0% Max0.31%6Hydroxyl Value (mgKOHgm)16 - 1817.09

Description White or almost white crystalline powder or colourless crystals CompliesSolubility Free soluble in ethanol (95 per cent). In either and in methol; very slightly soluble in water CompliesIdentification IR A) Melting Point 125 C to 128 C 126 CB) By IR Infrared absorption spectrophgotometry : Positive PositiveC) TLC Chromatogram Spot : to Comply CompliesAppearance of solution Solution should be clear & not more intensely coloured than BYS6 solution CompliesAcidity NMT 0.1 ML OF 0.1 N NaOH Required to change the colour of the indicator to blue 0.08ml of 0.1M NaOH RequiredRelated Substance 1) Impurity NMT 05% 0.36%2) Unspecified Impurities NMT 0.5% 0.15%3) Total Impurities NMT 1.0% 0.28%Sulphated Ash NMT 0.1% 0.078%Assay By HPLC 98.0% to 102.0% 98.1%

Appearance White to faintly yellowish powder Almost white crystalineSolubility Freely soluble in anhydrous formic acid. Very Slightly soluble in Ether and Methylene chloride. Practically Insoluble in Alcohol and In water. CompliesIdentification A) IR IR Spectrum concordant with reference working standard CompliesB) By TLC The Rf Value of the principal spot observed in the chromatogram of the test solution corresponds to that of the principal spot in Std Solution CompliesResidue On Ignition NMT 0.2% 0.05%Chromatographic Purity (By TLC) NMT 0.5% CompliesLoss On Drying NMT 0.5% 0.30%Assay (On Dried Basis) By Titration 98.00% to 102.0% 99.02%

AppearanceCompliesWhite or yellowish white powderCompliesA. IRCompliesB. The substance dissolves3pH (1.0g in 20.0ml)3.63.0 7.04Water3.8%5.0%5Vinylpyrrolidinone0.02%0.2%6K-Value29.725.0 34.0