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Sodium Chloride Specificatons of BP Ph Eur USP IP Analytical Reagent FCC Food Grade Manufacturers & Exporters Please visit Sodium Chloride USP NF ACS BP Ph Eur EP JP IP Analytical reagent FCC Food grade Manufacturers our associates world class FDA-GMP approved, ISO-9001 Certified facility Anmol Chemicals Sodium Chloride CAS Number 7647-14-5 Sodium Chloride USP Grade Specifications: NaCl --- 58.44 Sodium Chloride CAS 7647-14-5 DEFINITION Sodium Chloride contains NLT 99.0% and NMT 100.5% of sodium chloride (NaCl), calculated on the dried basis. IDENTIFICATION A. Identification Tests General Sodium: Meets the requirements B. Chloride: Sample solution: 3 mg of Sodium Chloride in 2 mL of water Analysis: Acidify the Sample solution with diluted nitric acid and add 0.4 mL of silver nitrate. Shake, and allow to stand. A curdled, white precipitate is formed. Centrifuge, wash the precipitate with three 1-mL portions of water, and discard the washings. Carry out this operation rapidly in subdued light, disregarding the fact that the supernatant may not become perfectly clear. Suspend the precipitate in 2 mL of water and add 1.5 mL of 10 N ammonium hydroxide. Acceptance criteria: The precipitate dissolves easily with the possible exception of a few large particles, which dissolve more slowly. Aluminum (where it is labeled as intended for use in the manufacture of peritoneal dialysis solutions, hemodialysis solutions, or hemofiltration solutions): To pass the test. Acceptance criteria: The fluorescence of the Sample solution does not exceed that of the Standard solution (0.2 ppm). Arsenic: NMT 1 ppm Barium: To pass the test. Ferrocyanides: To pass the test. Iodides: To pass the test. Iron: To pass the test. --- (NMT 2 ppm). Limit of Bromides: To pass the test. --- (NMT 100 ppm). Limit of Phosphates: To pass the test. --- (NMT 25 ppm). Limit of Potassium (where it is labeled as intended for use in the manufacture of injectable dosage forms, peritoneal dialysis solutions, hemodialysis solutions, or hemofiltration solutions): To pass the test. Acceptance criteria: NMT 500 ppm Magnesium and Alkaline-Earth Metals: To pass the test. --- (NMT 100 ppm, calculated as Ca). Nitrites: To pass the test. Sulfate: To pass the test. Appearance of Solution: Dissolve 20.0 g of Sodium Chloride in carbon dioxide-free water, and dilute with the same solvent to 100.0 mL. This solution is clear and colorless. Acidity or Alkalinity: To pass the test. Loss on Drying: Sample: 1.000 g Analysis: Dry the Sample in an oven at 105C for 2 h. Acceptance criteria: NMT 0.5% Bacterial Endotoxins Test: To pass the test. Sterility Tests: Where the label states that Sodium Chloride is sterile, it meets the requirements for Sterility under the relevant dosage form monograph(s) in which Sodium Chloride is used. Specifications of Sodium Chloride BP Grade NaCl -- 58.44 -- CAS 7647-14-5 Action and use: Used in treatment of electrolyte deficiency. DEFINITION Content: 99.0 per cent to 100.5 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder or colourless crystals or white or almost white pearls. Solubility Freely soluble in water, practically insoluble in anhydrous ethanol. IDENTIFICATION A. It gives the reactions of chlorides. B. It gives the reactions of sodium. TESTS Solution S: If the substance is in the form of pearls crush before use. Dissolve 20.0 g in carbon dioxide-free water prepared from distilled water and dilute to 100.0 ml with the same solvent. Appearance of solution: Solution S is clear and colourless. Acidity or alkalinity: To 20 ml of solution S add 0.1 ml of bromothymol blue solution. Not more than 0.5 ml of 0.01 M hydrochloric acid or 0.01 M sodium hydroxide is required to change the colour of the indicator. Bromides: Maximum 100 ppm. Ferrocyanides: Dissolve 2.0 g in 6 ml of water. Add 0.5 ml of a mixture of 5 ml of a 10 g/l solution of ferric ammonium sulphate in a 2.5 g/l solution of sulphuric acid and 95 ml of a 10 g/l solution of ferrous sulphate. No blue colour develops within 10 min. Iodides: Moisten 5 g by the drop wise addition of a freshly prepared mixture of 0.15 ml of sodium nitrite solution, 2 ml of 0.5 M sulphuric acid , 25 ml of iodide-free starch solution and 25 ml of water. After 5 min, examine in daylight. The mixture shows no blue colour. Nitrites: To 10 ml of solution S add 10 ml of water. The absorbance is not greater than 0.01 at 354 nm. Phosphates: Maximum 25 ppm. Sulphate: Maximum 200 ppm. Aluminium: Maximum 0.2 ppm, if intended for use in the manufacture of peritoneal dialysis solutions, hem dialysis solutions or haemofiltration solutions. Arsenic: Maximum 1 ppm, determined on 5 ml of solution S. Barium: To 5 ml of solution S add 5 ml of distilled water and 2 ml of dilute sulphuric acid. After 2 h, any opalescence in the solution is not more intense than that in a mixture of 5 ml of solution S and 7 ml of distilled water. Iron: Maximum 2 ppm, determined on solution S. Magnesium and alkaline-earth metals: Maximum 100 ppm, calculated as Ca and determined on 10.0 g. Potassium: maximum 5.00 x 102 ppm, if intended for use in the manufacture of parenteral dosage forms or hem-dialysis, haemofiltration or peritoneal dialysis solutions. Atomic emission spectrometry: To pass the test Heavy metals: Maximum 5 ppm. Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C for 2h. Bacterial endotoxins: Less than 5 IU/g, if intended for use in the manufacture of parenteral dosage forms without a further appropriate procedure for removal of bacterial endotoxins. Specifications of NaCl, Sodium Chloride IP Grade: Dry Basis Assay: 99.0% - 100.5% Description: White, crystalline powder. Solubility: Freely soluble in water; practically insoluble in ethanol. Acidity or alkalinity: Passes Test Clarity and Colour of Solution: Clear & colourless solution (10% w/w). Arsenic: 1 ppm maximum. Barium: Passes Test Bromide: 0.1% maximum. Calcium & Magnesium as Ca: 50 ppm maximum. Ferro cyanide: Passes Test Heavy Metals: 5 ppm maximum. Iodide: Passes Test Iron: 20 ppm maximum. Loss on Drying: 1% maximum. Potassium: 0.1% maximum. Sodium Chloride Analytical Regent Specifications Analytical Reagent Chemicals Sodium Chloride NaCl Formula Wt 58.44 CAS Number 7647-14-5 REQUIREMENTS Assay: min 99.0% NaCl pH of a 5% solution: 5.0-9.0 at 25C MAXIMUM ALLOWABLE Insoluble matter: 0.005% Iodide (I): 0.002% Bromide (Br): 0.01% Chlorate and nitrate (as NO3): 0.003% Nitrogen compounds (as N): 0.001% Phosphate (PO4): 5 ppm Sulfate (SO4): 0.004% Barium (Ba): Passes test Heavy metals (as Pb): 5 ppm Iron (Fe): 2 ppm Calcium (Ca): 0.002% Magnesium (Mg): 0.001% Potassium (K): 0.005% SDS MSDS of Sodium Chloride BP Ph Eur EP JP USP NF IP ACS Analytical Reagent FCC Food grade Manufacturers

Crystal Clear Products and the group companies are manufacturing chemicals since several decades. We have automatic vacuum operated titanium evaporators and SS316 equipments to produce top grade of chemical products. We have toll manufacturers and representatives in China, UAE, Europe, Canada & USA and agents & customers in all countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Bangkok Thailand, Kaula Lumpur Malaysia, Dubai UAE etc. & sales representative in Chicago, Houston New York & Los Angeles, USA. Associated units are FDA-GMP certified, Halal and/or Kosher certified, REACH registered, ISO-9001, ISO-22000 HACCP certified, Crisil Rated.

Contact Sodium Chloride IP BP Ph Eur EP JP USP NF ACS Analytical Reagent FCC Food Grade manufacturers exporters at:

Crystal Clear Products
Plot No-C1-1031-9, GIDC Estate, Panoli, Ankleshwar, Gujarat - 393002. India
Telephone Mobile: 91-7506449333; e-mail: info@crystalclearproducts.org

e-mail: info@crystalclearproducts.org

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