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Lauryl Methacrylate/Sodium Methacrylate Crosspolymer Dispersion (40 per cent)

Compositional Guideline: Lauryl Methacrylate/Sodium Methacrylate Crosspolymer Dispersion (40 per cent)  permitted for use in listed medicines.

Description

Lauryl methacrylate/sodium methacrylate crosspolymer dispersion (40 per cent) is a white or pale yellow to light yellow liquid that is a copolymer of the monomers, lauryl methacrylate and methacrylic acid, crosslinked with ethylene glycol dimethacrylate (49:35:16 molar ratio). The radical polymerisation is carried out in the presence of lauroyl peroxide and sodium stearoyl-N-methyltaurate. Phenoxyethanol (0.89-1.09%) is added as a preservative. The ingredient is a water dispersion that contains 40% of lauryl methacrylate/sodium methacrylate crosspolymer.

Molecular formula: (C16H30O2)a(C10H14O4)b(C4H5O2Na)c

Molecular structure:

Lauryl Methacrylate/Sodium Methacrylate Crosspolymer Dispersion

Test

Method reference

Acceptance criteria

CHARACTERISATION
General properties
AppearanceVisualWhite or pale-yellow opaque liquid
OdourOrganolepticCharacteristic odour
pH (undiluted solution at 20 oC)USP <791>6 – 10
SolubilityVisualInsoluble in various organic solvents
Specific Gravity (at 20 oC)USP <841>1.003 g/mL
Viscosity (at 20 oC)Höppler viscometer8.4 mPa.s 
Particle SizeUSP <430>2.1 – 4.0 µm
Loss on DryingUSP <731>58.0 – 62.0%
Identity
FT-IRUSP <1854>Observation of characteristic peaks at 2922, 1727, 1466, and 1147 cm-1.
Elemental impurities
Total Heavy MetalsUSP <233>≤20 ppm
LeadUSP <233>≤5 ppm
ArsenicUSP <233>≤3 ppm
MercuryUSP <233>≤3 ppm
CadmiumUSP <233>≤2 ppm
Other organic impurities 
Lauryl MethacrylateGC[1]≤80 ppm
Ethylene Glycol DimethacrylateGC[1]≤80 ppm
Methacrylic AcidLC[2]≤80 ppm
Lauroyl PeroxideLC[3]≤200 ppm
Microbiology
While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 100 'Microbiological Standards for Medicines' mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 11 of the Order.

Footnotes

  1. GC: Column: Fused silica capillary column of 0.2 to 0.3 mm i.d. and 25 to 30 m length with 5% phenylmethylsiloxane of 0.2 to 0.4 μm thickness cross-linked to the inner surface; Column temperature: 10°C per minute from 60°C to 280°C; Carrier gas: Helium; Flow rate: 1.0 mL per minute; Split ratio: Splitless; Inlet temperature: 150°C; Detector: Hydrogen flame ionisation detector; Detecting gas: Hydrogen (combustion gas) and air (support gas); Detector temperature: 300°C.

  2. LC: Column: Stainless steel tube with an inner diameter of 4.6 mm and a length of 15 cm filled with 5 μm octadecylsilylated silica gel; Column temperature: 40°C; Mobile phase: Water/acetonitrile mixture (3:2) with phosphoric acid (0.1% w/v); Flow rate: 1.0 mL per minute; Detector: UV-Vis (measurement wavelength: 205 nm).

  3. LC: Column: Stainless steel tube with an inner diameter of 4.6 mm and a length of 15 cm filled with 5 μm octadecylsilylated silica gel; Column temperature: 40°C; Mobile phase: Acetonitrile/water mixture (97:3); Flow rate: 1.0 mL per minute; Detector: UV-Vis (measurement wavelength: 210 nm).

Abbreviations

  • CAS = Chemical Abstract Services
  • FT-IR = Fourier transform infrared spectroscopy
  • GC = Gas chromatography
  • LC = Liquid chromatography
  • USP = United States Pharmacopeia
  • UV-Vis = Ultraviolet-visible spectroscopy
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