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Trefriw Wells mineral water

Compositional guideline for 'Trefriw Wells mineral water' permitted for use in listed medicines

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Name of the ingredient

Trefriw Wells mineral water (AAN)

Definition of the ingredient

Trefriw Wells mineral water is a naturally-occurring mineral water containing Fe2+ (ferrous ion), sourced from Trefriw Wells Spa, North Wales, United Kingdom.

Table 1: Ingredient specific requirements

Test Method reference Acceptance criteria
Description
Appearance Visual Clear, colourless liquid
Odour Organoleptic Slightly metallic
Characteristics
pH BP (Appendix V L) 2.5-3.5
Conductivity (at 20oC) BP (Appendix V O) 1700–2500 µS/cm
Turbidity BP (Appendix IV A) No more than 2 FTU
Assay
Ferrous ion (Fe2+) Colorimetric (FerroZineTM)

166–219 mg/L

Table 2: Incidental constituents

Test Method reference Acceptance criteria
Incidental metals and non-metals
Total heavy metals AAS Not more than 10 ppm
Chromium AAS Not more than 50 ppb
Selenium AAS Not more than 10 ppb
Cyanide Colorimetric Not more than 50 ppb
Beryllium

ICP-ES1

Not more than 60 ppb1
Pesticide residues and environmental contaminants: (including agricultural and veterinary substances)
Pesticide residues Ph Eur method 2.8.13 Complies
Other organic or inorganic impurities or toxins
Radiological quality
Gross α activity

Evaporation or Coprecipitation method1

Not more than 0.5 Bq/L1
Gross β activity

Evaporation or Coprecipitation method1

Not more than 0.5 Bq/L1
Microbiology
Sporothrix fungus Culture2 Absent in 100 mL
Iron-oxidising bacteria Culture2 Absent in 100 mL
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. 77 '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 9 of the Order.
Notes
  1. NHMRC (2011), Australian Drinking Water Guidelines Paper 6 National Water Quality Management Strategy.
  2. Note: Original reference refers to the 2004 version of the guidelines
  1. Johnson DB and Hallberg KB (2007), Techniques for detecting and identifying acidophilic mineral-oxidising microorganisms. Biomining, Rawlings DE and Johnson DB (eds) pp 237-262.
  2. Hallberg KB and Johnson DB (2007), Isolation, enumeration, growth and preservation of acidophilic prokaryotes. In: Manual of Environmental Microbiology 3rd Edition. Hurst CJ, Crawford R, Garland JL, Lipson DA, Mills AL and Stetzenbach LD (eds). pp 1155-1165. American Society of Microbiology, Washington, DC.
  3. These references describe techniques for the detection of iron-oxidising bacteria, but they are also applicable to the detection of Sporothrix fungus.

Key to abbreviations

AAS: Atomic absorption spectroscopy

BP: British Pharmacopoeia

Bq/L: Becquerel/L

FTU: Formazin turbidity unit

ICP-MS: Inductively coupled plasma emission spectroscopy

NHMRC: National Health and Medical Research Council

µS/cm: micro Siemens/cm

 

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