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Sodium Lactate Manufacturer Exporter BP Ph Eur USP FCC Food Grade Manufacturer Exporter

Crystal Clear Products is a manufacturer exporter company manufacturing several chemicals including Sodium Lactate and IP BP Ph Eur USP NF JP ACS AR Analytical Reagent FCC Food Grade, Pharmaceutical Chemicals at best prices. The group has offices and factories in India USA and UAE and toll manufacturers in China and sells to almost every country in the world.

The manufacturing facilities of our partner manufacturers have one or more of FDA-cGMP-GLP certification, ISO-9001 certification, Halal and/or Kosher certification, REACH pre-registration ISO-22000 HACCP. We also allow third party inspection of products offered. We can offer small quantities from laboratory and trial packs to large shipments of container loads of material.

Hazard Statements:
Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.
Not considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200)
Signal Word: None

Transport Information
DOT USA, TDG Canada & ADR/RID Europe
: Not dangerous goods.
IMO/IMDG: Not dangerous goods.
IATA/ICAO: Not dangerous goods.

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Sodium Lactate IP BP Ph Eur USP NF FCC Food AR ACS Reagenr Grade Manufacturers

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CAS Number 72-17-3 Sodium Lactate, EINECS: 200-772-0, Molecular Weight: 112.06, Chemical Formula: C3H5NaO3

Sodium Lactate Solution USP Grade Specifications
Sodium Lactate Solution is an aqueous solution containing not less than 50.0 percent, by weight, of monosodium lactate. It contains not less than 98.0 percent and not more than 102.0 percent of the labeled amount of C3H5NaO3.
Label it to indicate its content of sodium lactate.

Identification: It responds to the tests for Sodium and for Lactate.
pH: between 5.0 and 9.0.
Chloride: A portion, equivalent to 1 g of sodium lactate, shows no more chloride than corresponds to 0.7 mL of 0.020 N hydrochloric acid (0.05%).
Sulfate: To 10 mL of a solution (1 in 100) add 2 drops of hydrochloric acid and 1 mL of barium chloride TS: no turbidity is produced.
Heavy metals: Dilute a quantity of Solution, equivalent to 2.0 g of sodium lactate, with 1 N acetic acid to 25 mL: the limit is 0.001%.
Sugars: To 10 mL of hot alkaline cupric tartrate TS add 5 drops of Solution: no red precipitate is formed.
Limit of citrate, oxalate, phosphate, or tartrate: Dilute 5 mL with recently boiled and cooled water to 50 mL. To 4 mL of this solution add 6 N ammonium hydroxide or 3 N hydrochloric acid, if necessary, to bring the pH to between 7.3 and 7.7. Add 1 mL of calcium chloride TS, and heat in a boiling water bath for 5 minutes: the solution remains clear.
Limit of methanol and methyl esters
: To pass the test.


Sodium Lactate BP Grade Ph Eur Specifications

DEFINITION
Solution of a mixture of the enantiomers of sodium 2-hydroxypropanoate in approximately equal proportions.

Content
Minimum 50.0 per cent m/m of sodium 2-hydroxypropanoate (C3H5NaO3); 96.0 per cent to 104.0 per cent of the content of sodium lactate stated on the label.

CHARACTERS
Appearance: Clear, colourless, slightly syrupy liquid.
Solubility: Miscible with water and with alcohol.

IDENTIFICATION
A. To 0.1 ml add 10 ml of water. 5 ml of the solution gives the reaction of lactates.
B. It gives reaction of sodium.

TESTS
Solution S: Dilute a quantity of the substance to be examined corresponding to 40.0 g of sodium lactate to 200 ml with distilled water.
Appearance of solution: The substance to be examined is clear and not more intensely coloured than reference solution.
pH: 6.5 to 9.0 for the substance to be examined.
Reducing sugars and sucrose: To 5 ml of the substance to be examined add 2 ml of dilute sodium hydroxide solution and 0.2 ml of copper sulphate solution. The solution is clear and blue and remains so on boiling. Add to the hot solution 4 ml of hydrochloric acid. Boil for 1 min. Add 6 ml of strong sodium hydroxide solution and heat to boiling again. The solution is clear and blue.
Methanol: the limit is 50 ppm calculated with reference to sodium lactate, if intended for use in the manufacture of parenteral dosage forms, dialysis, haemodialysis or haemofiltration solutions.
Chlorides: Maximum 50 ppm calculated with reference to sodium lactate.
Oxalates and phosphates: To pass the test.
Sulphates: Maximum 100 ppm calculated with reference to sodium lactate.
Aluminium: Maximum 0.1 ppm, if intended for use in the manufacture of parenteral dosage forms, dialysis, haemodialysis or haemofiltration solutions.
Atomic absorption spectrometry: To pass the test.
Barium: To 10 ml of solution S add 10 ml of calcium sulphate solution. Allow to stand for 30 min. Any opalescence in the solution is not more intense than that of a standard prepared at the same time and in the same manner using a mixture of 10 ml of solution S and 10 ml of distilled water R.
Iron: Maximum 10 ppm calculated with reference to sodium lactate.
Heavy metals: Maximum 10 ppm calculated with reference to sodium lactate.
Bacterial endotoxins: Less than 5 IU/g, if intended for use in the manufacture of parenteral dosage forms without a further appropriate procedure for the removal of bacterial endotoxins.


Sodium Lactate Solution FCC Food Grade Specifications
2-Hydroxypropanoic Acid, Monosodium Salt
C3H5NaO3 Formula weight, anhydrous 112.06
CAS 72-17-3

DESCRIPTION
Sodium Lactate Solution occurs as a clear, colorless or practically colorless, slightly viscous liquid that is odorless or has a slight, not unpleasant odor. It is miscible with water. It is normally available in solutions with concentrations ranging from 60% to about 80%, by weight.

Function: Emulsifier; flavor enhancer; flavoring agent or adjuvant; humectant; pH control agent.

REQUIREMENTS
Indicate the content, by weight, of sodium lactate (C3H5NaO3).
Identification: A sample gives positive tests for Sodium and for Lactate.
Assay: Not less than 50.0%, by weight, and not less than 98.0% and not more than 102.0%, by weight, of the labeled amount of C3H5NaO3.
Chloride: Not more than 0.05%.
Citrate, Oxalate, Phosphate, or Tartrate: Passes test.
Cyanide: Not more than 0.5 mg/kg.
Lead: Not more than 2 mg/kg.
Methanol and Methyl Esters: Not more than 0.025%.
pH: Between 5.0 and 9.0.
Sugars: Passes test.
Sulfate: Not more than 0.005%.

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Last updated 11/19/2022

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