Glutaraldehyde or Glutaral Concentrate Commercial Pure & BP Ph Eur USP FCC Food Grade Manufacturers & Exporters
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Glutaraldehyde or Glutaral Concentrate CAS Number 111-30-8
Glutaral Concentrate USP Grade Specifications:
C5H8O2 100.12
Pentanedial; Glutaraldehyde CAS 111-30-8
DEFINITION
Glutaral Concentrate is a solution of glutaraldehyde in Purified Water. It contains NLT 100.0% and NMT 104.0% of the labeled amount of glutaral (C5H8O2). The labeled amount is 50.0 g of C5H8O2 per 100 g of Concentrate.
IDENTIFICATION
A.
Solution A: Add 4 mL of sulfuric acid to 0.8 g of 2,4-dinitrophenylhydrazine, then add 6 mL of water, dropwise, with swirling. When dissolution is essentially complete, add 20 mL of alcohol, and filter. The filtrate is the 2,4-dinitrophenylhydrazine reagent.
Analysis: Add 0.4 mL of Concentrate to 20 mL of Solution A, mix by swirling, and allow to stand for 5 min. Collect the precipitate on a filter, and rinse thoroughly with alcohol. Dissolve the precipitate in 20 mL of hot ethylene dichloride, filter, and cool the filtrate in an ice bath until crystallization occurs. Collect the precipitate on a filter. Redissolve the precipitate by refluxing with 30 mL of acetone, filter, and cool the filtrate in an ice bath until crystallization occurs. Collect the precipitate on a filter.
Acceptance criteria: The 2,4-dinitrophenylhydrazone so obtained melts at 185C –195C, within a 3C range.
ASSAY: To pass the test.
Acidity:
Analysis: Transfer 60.0 g to a conical flask, add phenolphthalein TS, and titrate with 0.10 N alcoholic potassium hydroxide to a pink endpoint that is permanent for NLT 15 s.
Acceptance criteria: NMT 40 mL of 0.10 N potassium hydroxide is consumed, corresponding to NMT 0.4% (w/w) of acid, calculated as acetic acid.
pH: 3.7–4.5
Clarity of Solution:
Analysis: Transfer 5.0 mL of Concentrate to a glass-stoppered, 100-mL graduated cylinder, add water to obtain 100 mL of mixture, insert the stopper, and mix by inverting the graduated cylinder several times. Allow the bubbles to rise and view downward through the solution against a dark background.
Acceptance criteria: The solution is clear.
This article is not intended for direct administration to humans or animals.
Strong Glutaraldehyde Solution BP Ph Eur Grade Specifications:
C5H8O2 --- 100.1 --- CAS 111-30-8
DEFINITION
Strong Glutaraldehyde Solution is an aqueous solution of glutaraldehyde (pentanedial). It contains not less than 47.0% and not more than 53.0% w/w of glutaraldehyde, C5H8O2.
CHARACTERISTICS
A colourless or almost colourless solution.
IDENTIFICATION
A. Heat 1 mL with 10 mL of a solution containing 1 g of hydroxylamine hydrochloride and 2 g of sodium acetate in water on a water bath for 10 minutes, allow to cool and filter. The melting point of the residue, after washing with water and drying at 105C, is about 178C.
B. Add 0.05 mL to 2 mL of ammoniacal silver nitrate solution and mix gently for a few minutes. Silver is deposited.
TESTS
Acidity: Dilute 10 mL with 10 mL of carbon dioxide-free water and titrate with 0.1M sodium hydroxide VS using bromothymol blue solution as indicator. Not more than 5.0 mL of 0.1M sodium hydroxide is required to change the colour of the solution.
Clarity and colour of solution: Dilute 1 volume with 4 volumes of water. The resulting solution is clear, and not more intensely coloured than reference solution.
Weight per mL: 1.126 to 1.134 g.
Glutaraldehyde Solution BP Ph Eur Specifications:
DEFINITION
Glutaraldehyde Solution is a dilution of Strong Glutaraldehyde Solution in a mixture of Purified Water and Ethanol (96 per cent).
In making Glutaraldehyde Solution, Ethanol (96 per cent) may be replaced by Industrial Methylated Spirit.
Content of glutaraldehyde, C5H8O2: 9.2 to 10.5% w/v.
IDENTIFICATION
A. Heat 5 mL with 10 mL of a solution containing 1 g of hydroxylamine hydrochloride and 2 g of sodium acetate on a water bath for 10 minutes, allow to cool and filter. The melting point of the residue, after washing with water and drying at 105C, is about 178C, Appendix V A.
B. To 1 mL add 2 mL of ammoniacal silver nitrate solution and mix gently for a few minutes. Silver is deposited.
TESTS
Ethanol content: 50 to 60% v/v.
Glutaraldehyde FCC Food Grade Speifications:
Glutaral; 1,5-Pentanedial
C5H8O2 Formula weight 100.12
CAS: 111-30-8
DESCRIPTION
Glutaraldehyde occurs as a clear, nearly colorless, aqueous solution. It is miscible with water. The grades of Glutaraldehyde suitable for food use usually have concentrations between 15% and 50%.
Function: Fixing agent in the immobilization of enzyme preparations; cross-linking agent for microencapsulating flavoring substances; antimicrobial for sugar milling.
REQUIREMENTS
Labelling: Indicate the concentration of Glutaraldehyde.
Identification: 2,4-Dinitrophenylhydrazine Reagent Add 4 mL of sulfuric acid to 0.8 g of 2,4-dinitrophenylhydrazine, then while swirling, add 6 mL of water, dropwise. When dissolution is essentially complete, add 20 mL of alcohol, mix, and filter. The filtrate is the reagent.
Procedure Add 0.4mLof sample to 20mLof 2,4-Dinitrophenylhydrazine Reagent. Mix by swirling and allow the mixture to stand for 5 min. Collect the precipitate on a filter, and rinse thoroughly with alcohol. Dissolve the precipitate in 20 mL of hot ethylene dichloride, filter, and cool the filtrate in an ice bath until crystallization occurs. Collect the precipitate on a filter. Redissolve the precipitate by refluxing with 30 mL of acetone, filter, and cool the filtrate in an ice bath until crystallization occurs. Collect the precipitate on a filter. The 2,4-dinitrophenylhydrazone so obtained melts between 185C and 195C.
Assay: Not less than 100.0% and not more than 105.0% of the labelled amount of C5H8O2.
Lead: Not more than 2 mg/kg.
pH: Between 3.1 and 4.5.
SDS MSDS of Glutaraldehyde or Glutaral Concentrate BP Ph Eur EP JP USP NF IP ACS Analytical Reagent FCC Food grade Manufacturers |
