Macrogols

Macrogols BP
Ph Eur
Action and use: Non-ionic surfactant.

DEFINITION
Mixtures of polymers with the general formula H-(OCH2-CH2)n-OH where n represents the average number of oxyethylene groups. The type of macrogol is defined by a number that indicates the average relative molecular mass. A suitable stabiliser may be added.

IDENTIFICATION
A. It complies with the test for viscosity (see Tests).
B. To 1 g in a test-tube add 0.5 ml of sulphuric acid, close the test-tube with a stopper fitted with a bent delivery tube and heat until white fumes are evolved. Collect the fumes via the delivery tube into 1 ml of mercuric chloride solution. An abundant white, crystalline precipitate is formed.
C. To 0.1 g add 0.1 g of potassium thiocyanate and 0.1 g of cobalt nitrate and mix thoroughly with a glass rod. Add 5 ml of methylene chloride R and shake. The liquid phase becomes blue.

TESTS
Appearance of solution: The solution is clear and not more intensely coloured than reference solution.
Dissolve 12.5 g in water and dilute to 50 ml with the same solvent.
Acidity or alkalinity: Dissolve 5.0 g in 50 ml of carbon dioxide-free water and add 0.15 ml of bromothymol blue solution. The solution is yellow or green. Not more than 0.1 ml of 0.1 M sodium hydroxide is required to change the colour of the indicator to blue.
Viscosity: The viscosity is calculated using a density given in Table 1444.-1.
For macrogols having a relative molecular mass greater than 400, determine the viscosity on a 50 per cent m/m solution of the substance to be examined.
Freezing point: See Table 1444.-2.
Hydroxyl value: Introduce m g (see Table 1444.-3) into a dry conical flask fitted with a reflux condenser. Add 25.0 ml of phthalic anhydride solution, swirl to dissolve and boil under a reflux condenser on a hot plate for 60 min. Allow to cool. Rinse the condenser first with 25 ml of pyridine and then with 25 ml of water, add 1.5 ml of phenolphthalein solution and titrate with 1 M sodium hydroxide until a faint pink colour is obtained (n1 ml). Carry out a blank test (n2 ml).
Calculate the hydroxyl value using the expression: [56.1x(n2-n1)]m
For macrogols having a relative molecular mass greater than 1000, if the water content is more than 0.5 per cent, dry a sample of suitable mass at 100-105C for 2 h and carry out the determination of the hydroxyl value on the dried sample.
Reducing substances: Dissolve 1 g in 1 ml of a 10 g/l solution of resorcinol and warm gently if necessary. Add 2 ml of hydrochloric acid. After 5 min the solution is not more intensely coloured than reference solution.
Formaldehyde: Maximum 30 ppm.
competent authority may impose a limit of not more than 15 ppm.
Ethylene glycol and diethylene glycol: LimitıMaximum 0.4 per cent, calculated as the sum of the contents of ethylene glycol and diethylene glycol.
Ethylene oxide and dioxan: Maximum 1 ppm of ethylene oxide and 10 ppm of dioxan.
Heavy metals: Maximum 20 ppm.
Water: Maximum 2.0 per cent for macrogol with a relative molecular mass not greater than 1000 and maximum 1.0 per cent for macrogol with a relative molecular mass greater than 1000, determined on 2.00 g.
Sulphated ash: Maximum 0.2 per cent, determined on 1.0 g.

STORAGE
In an airtight container .

LABELLING
The label states:
the type of macrogol;
the content of formaldehyde.

General Properties and Specifications of Lithium stearate or Lithium octadecenoate:
Appearance: White soft solid.
Odor: Fatty odor.
Chloride: 0.2 % maximum.
Sulfate: 0.2 % maximum.
Melting point: 220C.

Certifications :
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is cGMP, GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL, EXCiPACT, WC, COPP, WHO-GMP and WC certified. We are also REACH registered for export to European countries.