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Lactic Acid Specifications of Commercial Pure & BP Ph Eur USP FCC Food Grade Manufacturers & Exporters

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Lactic Acid Suppliers Manufacturers
Lactic Acid CAS Number 50-21-5, 598-82-3 and 79-33-4

Lactic Acid USP Grade Specifications:
Propanoic acid, 2-hydroxy-;
Lactic acid --- CAS 50-21-5

DEFINITION
Lactic Acid is a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5), equivalent to a total of NLT 88.0% and NMT 92.0%, by weight, of lactic acid (C3H6O3). It is obtained by the lactic fermentation of sugars or is prepared synthetically. Lactic Acid obtained by fermentation of sugars is levorotatory, whereas that prepared synthetically is racemic.
[Note: Lactic Acid prepared by fermentation becomes dextrorotatory on dilution, which hydrolyzes l-(−)-lactic acid lactate to l-(+)-lactic acid.]

IDENTIFICATION
A. Identification Tests—General, Lactate Meets the requirements.

Chloride:
Sample solution: 1 in 100
Analysis: To 10 mL of the Sample solution acidified with nitric acid add a few drops of silver nitrate.
Acceptance criteria: No opalescence is produced immediately.
Sulfate:
Sample solution: 1 in 100
Analysis: To 10 mL of the Sample solution add 2 drops of hydrochloric acid and 1 mL of barium chloride.
Acceptance criteria: No turbidity is produced.
Residue on Ignition:
Sample: 5 mL, accurately weighed
Acceptance criteria: NMT 3 mg (0.05%)
Limit of Citric, Oxalic, Phosphoric, or Tartaric Acid:
Sample solution: 1 in 10
Analysis: To 10 mL of the Sample solution add 40 mL of calcium hydroxide TS, and boil for 2 min.
Acceptance criteria: No turbidity is produced.
Readily Carbonizable Substances:
Sample: 5 mL
Analysis: Rinse a test tube with sulfuric ;acid, and allow to drain for 10 min. Add 5 mL of sulfuric acid to the test tube, carefully overlay it with the Sample, and maintain the tube at 15°.
Acceptance criteria: No dark color develops at the interface of the two acids within 15 min.
Optical Rotation, Angular Rotation −0.05° to +0.05° for racemic Lactic Acid.
Sugars:
Sample: 5 drops
Analysis: To 10 mL of hot alkaline cupric tartrate add the Sample.
Acceptance criteria: No red precipitate is formed.
Packaging and Storage: Preserve in tight containers.

Lactic Acid BP Ph Eur Grade Specifications
C3H6O3 -- 90.1 -- CAS 50-21-5

DEFINITION
Mixture of 2-hydroxypropanoic acid, its condensation products, such as lactoyl-lactic acid and polylactic acids, and water. The equilibrium between lactic acid and polylactic acids depends on the concentration and temperature. It is usually the racemate ((RS)-lactic acid).
Content: 88.0 per cent m/m to 92.0 per cent m/m of C3H6O3.

CHARACTERS
Appearance: Colourless or slightly yellow, syrupy liquid.
Solubility: Miscible with water and with ethanol (96 per cent).

IDENTIFICATION
A. Dissolve 1 g in 10 ml of water. The solution is strongly acidic.
B. Relative density: 1.20 to 1.21.
C. It gives the reaction of lactates.

TESTS
Solution S: Dissolve 5.0 g in 42 ml of 1 M sodium hydroxide and dilute to 50 ml with distilled water.
Appearance: The substance to be examined is not more intensely coloured than reference solution.
Ether-insoluble substances: Dissolve 1.0 g in 25 ml of ether. The solution is not more opalescent than the solvent used for the test.
Sugars and other reducing substances: To 1 ml of solution S add 1 ml of 1 M hydrochloric acid , heat to boiling, allow to cool and add 1.5 ml of 1 M sodium hydroxide and 2 ml of cupri-tartaric solution. Heat to boiling. No red or greenish precipitate is formed.
Methanol: Maximum 50 ppm, if intended for use in the manufacture of parenteral dosage forms.
Citric, oxalic and phosphoric acids: To pass the test.
Sulphates: Maximum 200 ppm.
Calcium: Maximum 200 ppm.
Heavy metals: Maximum 10 ppm.
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. Before use, neutralise the test solution to pH 7.0-7.5 with strong sodium hydroxide solution and shake vigorously.

Specifications of Lactic Acid FCC Food Grade
α-Hydroxypropionic Acid; 2-Hydroxypropionic Acid
C3H6O3 -- Formula weight 90.08
INS: 270 CAS: L(+)-Lactic Acid CAS 79-33-4
CAS: DL-Lactic Acid CAS 598-82-3

DESCRIPTION
Lactic Acid occurs as a colorless or yellow, syrupy liquid consisting of a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is prepared synthetically. It is usually available in solutions containing the equivalent of from 50% to 90% lactic acid. It is hygroscopic, and when concentrated by boiling, the acid condenses to form lactic acid lactate, 2-(lactoyloxy)propanoic acid, that on dilution and heating, hydrolyzes to Lactic Acid. It is miscible with water and with alcohol.
Function: Acidifier.

REQUIREMENTS
Identification: A sample gives positive tests for Lactate.
Assay: Not less than 95.0% and not more than 105.0% of the labeled concentration of C3H6O3.
Chloride: Not more than 0.1%.
Citric, Oxalic, Phosphoric, or Tartaric Acid:Passes test.
Cyanide: Not more than 5 mg/kg.
Iron: Not more than 10 mg/kg.
Lead: Not more than 0.5 mg/kg.
Residue on Ignition: Not more than 0.1%.
Sugars: Passes test.
Sulfate: Not more than 0.25%.

SDS MSDS of Lactic Acid BP Ph Eur EP JP USP NF IP ACS Analytical Reagent FCC Food grade Manufacturers

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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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