Welcome to AKHIL HEALTHCARE PVT LTD
AKHIL HEALTHCARE PVT LTD
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OWNER
Mr MANOJ SHAH
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Year of Establishment
1980
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Primary Business
Retailer
Welcome to AKHIL HEALTHCARE PVT LTD
AKHIL HEALTHCARE PVT LTD
OWNER
Mr MANOJ SHAH
Year of Establishment
1980
Primary Business
Retailer

Sr. No Tests Specification Result 1 Appearance White Slab or pastilles White Slab 2 Solubility Practically insoluble in water, freely soluble in methylene chloride practically insoluble in ethanol (96%) Practically insoluble in water, freely soluble in methylene chloride practically insoluble in ethanol (96%) 3 Odor

Test results specification 1 characteristics complies white, fluffy powders, odour, slight and characteristics hydroscopic 2 identification complies a) 1. 1% dispersion with thymol blue-orange colour 2. 1% dispersion with cresol red yellow colour b) very viscous gel produce 3 limit of benzene (by gc) complies not more than 0.5% 4 heavy meals complies not more than 20 ppm 5 loss on drying 0.46% not more than 2.0% of ww at 80 c 6 sulphated ash 0.45% not more than 4.0% of ww 7 assay 59.40% not less than 56.0% and not more than 68% of carboxylic acid groups in – house specification 8 ph 2.85 1.0% solution limit 2.5 to 3.0 9 viscosity ………. 15000 to 35000 cps of 0.5% sol spindle 6 36255 cps 29400 to 39000 cps of 0.5% sol spindle 6 (20 epm 25 c, neutral solution) 10 clarity 95% 0.5 % solution has not less than 80% transmission

TEST SPECIFICATION RESULTS 1 Purity ≥ 99.8 wt% 99.98 wt% 2 Color ≤5 APHA 2 APHA 3 Water ≤0.05 wt% 0.0120 wt% 4 Sp. Gr (204°C) 0.785~0.787 0.786 5 Acidity ≤ 10 wt ppm 2 ppm 6 KMNO4_TEST ≥30 min 40 7 Residue after Evaporation ≤ 15 wt ppm 4 wt ppm

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 alcohol Clear , colourless, syrupy liquid Miacible with water and alcohol 2 (A.) HPLC Chromatogram Complies As per test (B) Optical Rotation +1.60° +1.50° to +3.50° (C.) Clarity @ 25 ° C Complies Clear syrupy liquid @ 25°C 3 Appearance Of Solution Complies The solution is clear & colourless 4 Condutivity 4.00 μS.cm-1 Not more than 10μS.cm-1 at temp of 20°C 5 Lead Complies 0.5 ppm (max) 6 Nickel Complies 1.0 ppm (max) 7 Redusing Sugar 13.16 ml Not less than 12.8 ml of 0.05 M Sodium Thiosulphate 8 Redusing Sugar After Hydrolysis 11.04 ml Not less than 8.0 ml of 0.05 M Sodium Thiosulphate 9 Water 29.70 28.0 to 32.0 % 10 Assay ( as D - Glucitol or D - Sorbitol) 88.81 72.0 to 92.0 % (on dried basis) 11 Total Viable Count 50 cfugm max 500 cfugm max 12 Total Fungal Count 30 cfugm max 150 cfugm max 13 E.Coli Absent Absentgm 14 Salmonella Absent Absentgm

Description Bulky white powder, odorless Complies Solubility Practically insoulble in water and in ethanol (95%). It dissolved in dilute acids. Complies Identification The resulting solution gives reaction A of magnesium salt Complies Colour of solution Solution A is not more intensely coloured than reference solution BS3. Complies Arsenic Not more than 4 ppm Complies Heavy Meals Not more than 30 ppm Complies Chloride Not more than 0.1% Complies Sulphate Not more than 0.5% Complies Iron Not more than 0.08% Complies Soluble Substance Not more than 1.0% Complies "Substance Insolube In Acetic Acid" Not more than 0.1% Complies Calcium Not more than 1.5% Complies Loss 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 litmus Solubility 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 test B. A brown, dy, nonsmearing film is formed, and it dissolved readily in water. Complies the test Heavy Metals Limit Max. 20 ppm 0.5 ppm Iodine (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%

Appearance White to creamish flakes White 2 Colour White to creamish White 3 Average molecular weight 6000 - 7012 6565 4 pH (5% in aqu. soln.) 4.5 - 7.5 4.71 5 Moisture 1.0% Max 0.31% 6 Hydroxyl Value (mgKOHgm) 16 - 18 17.09

Appearance White to faintly yellowish powder Almost white crystaline Solubility Freely soluble in anhydrous formic acid. Very Slightly soluble in Ether and Methylene chloride. Practically Insoluble in Alcohol and In water. Complies Identification A) IR IR Spectrum concordant with reference working standard Complies B) 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 Complies Residue On Ignition NMT 0.2% 0.05% Chromatographic Purity (By TLC) NMT 0.5% Complies Loss On Drying NMT 0.5% 0.30% Assay (On Dried Basis) By Titration 98.00% to 102.0% 99.02%

Appearance Complies White or yellowish white powder Complies A. IR Complies B. The substance dissolves 3 pH (1.0g in 20.0ml) 3.6 3.0 ~7.0 4 Water 3.8% ≤ 5.0% 5 Vinylpyrrolidinone 0.02% ≤ 0.2% 6 K-Value 29.7 25.0 ~ 34.0

Description White or almost white crystalline powder or colourless crystals Complies Solubility Free soluble in ethanol (95 per cent). In either and in methol; very slightly soluble in water Complies Identification IR A) Melting Point 125° C to 128° C 126 °C B) By IR Infrared absorption spectrophgotometry : Positive Positive C) TLC Chromatogram Spot : to Comply Complies Appearance of solution Solution should be clear & not more intensely coloured than BYS6 solution Complies Acidity 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 Required Related 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%
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