TGA - Therapeutic Goods Administration
TGA - Therapeutic Goods Administration
07/13/2021 | News release | Distributed by Public on 07/13/2021 01:08
Bittern
Name of the ingredient
Bittern (AAN)
Definition of the ingredient
Bittern is an essentially saturated solution of magnesium rich salts remaining after the physical collection of precipitated sodium chloride and less soluble salts including sulphates of magnesium (Epsomite) and some potassium sulfate. Only physical processes including manual removal of salt crystals; natural (solar) heat and/or natural evaporative winds are employed in the production process.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | An essentially colorless oily / syrupy fluid with a slight opalescence haze. It contains no or only a few visible crystals at 30oC, and is free from other visible inclusions. |
| Odour | Organoleptic | Virtually odourless to mild salty note |
| Taste | Organoleptic | Strong, deep pungent taste with bitter notes. |
| Characteristics | ||
| pH | Calibrated probe, 50% solution | 6.0 to 8.0 |
| Specific Gravity | Calibrated Instrument | 1.250 to 1.325 g/mL |
| Solubility | USP |
Very soluble in water Very soluble in ethanol |
| Identification | ||
| Magnesium | USP <191> | Complies with Identification test A for magnesium |
| Chlorides | USP <191> | Complies with Identification test A for Chlorides |
| Ions Profile | USP <233> | Matches assay |
| Assay - Major Ions | ||
| Chlorine | USP <233> | 260,000 to 300,000 ppm |
| Magnesium | USP <233> | 89,000 to 101,000 ppm |
| Assay - Characterising Ions | ||
| Sulfur | USP <233> | 9,500 to 12,500 ppm |
| Potassium | USP <233> | 4,500 to 12,000 ppm |
| Sodium | USP <233> | 4,500 to 9,000 ppm |
| Bromine | USP <233> | 1,500 to 3,000 ppm |
| Lithium | USP <233> | 0.5 to 5 ppm |
| Boron | USP <233> | Not more than 15 ppm |
| Zinc | USP <233> | Not more than 10 ppm |
| Rubidium | USP <233> | Not more than 10 ppm |
| Strontium + Silver + Caesium | USP <233> | Not more than 3 ppm |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Incidental metals and non-metals | ||
| Calcium | USP <233> | Not more than 200 ppm |
| Silicon | USP <233> | Not more than 30 ppm |
| Aluminium | USP <233> | Not more than 30 ppm |
| Manganese | USP <233> | Not more than 30 ppm |
| Iron | USP <233> | Not more than 30 ppm |
| Nickel | USP <233> | Not more than 3 ppm |
| Mercury | USP <233> | Not more than 3 ppm |
| Barium | USP <233> | Not more than 2 ppm |
| Arsenic | USP <233> | Not more than 1.5 ppm |
| Cadmium | USP <233> | Not more than 0.5 ppm |
| Lead | USP <233> | Not more than 0.5 ppm |
| Thallium | USP <233> | Not more than 100 ppb |
| Uranium | USP <233> | Not more than 100 ppb |
| Pesticide residues and environmental contaminants | ||
|
Pesticides, Herbicides, Fungicides Residues (see notes for list of included substances) |
Ph Eur method 2.8.13 or equivalent | Complies |
| Notes: Pesticides, Herbicides, Fungicides Residues to include: Aldrin, alpha-BHC, alpha-Endosulfan, Atrazine, Azinphos ethyl, Azinphos methyl, beta-BHC, beta-Endosulfan, Bifenthrin, Bioresmethrin, Bromophos ethyl, Bupirimate, Buprofezin, Carbaryl, Carbophenothion, Chlorfenvinphos (E), Chlorfenvinphos (Z), Chlorothalonil, Chlorpyrifos, Chlorpyrifos methyl, cis-Chlordane, Coumaphos, Cyfluthrin, Cyhalothrin, Cypermethrin, Cyprodinil, delta-BHC, Deltamethrin, Demeton-S-methyl, Diazinon, Dichlofluanid, Dichlorvos, Dicloran, Dicofol, Dieldrin, Difenoconazole, Dimethoate, Dimethomorph, Dioxathion, Diphenylamine, Diuron, Endosulfan sulfate, Endrin, Endrin aldehyde, Endrin ketone, Ethion, Fenamiphos, Fenarimol, Fenchlorphos, Fenitrothion, Fenoxycarb, Fenthion, Fenvalerate, Flumethrin, Flusilazole, Formothion, gamma-BHC (Lindane), HCB, Heptachlor, Heptachlor epoxide, Hexaconazole, Hexazinone, Imazalil, Iprodione, Linuron, Malathion, Metalaxyl, Methacrifos, Methidathion, Methoprene, Methoxychlor, Metolachlor, Mevinphos, Molinate, o-Phenylphenol, Oxychlordane, Oxyfluorfen, p,p-DD, p,p-DDE, p,p-DDT, Parathion (ethyl), Parathion methyl, Penconazole, Pendimethalin, Permethrin, Phenothrin, Phorate, Phosalone, Piperonyl butoxide, Pirimicarb, Pirimiphos ethyl, Pirimiphos methyl, Prochloraz Procymidone, Profenophos, Propargite, Propiconazole I, Propiconazole II, Prothiofos, Pyrimethanil, Simazine, Tebuconazole, Tebufenpyrad, Tetradifon, Thiometon, trans-Chlordane, Triazophos, Trifluralin, Vinclozolin | ||
| Other organic or inorganic impurities or toxins | ||
| Caesium 134 | High Resolution gamma ray spectrometry | Not more than 2Bq/kg |
| Caesium 137 | High Resolution gamma ray spectrometry | Not more than 2Bq/kg |
| Ruthenium-103 | High Resolution gamma ray spectrometry | Not more than 2Bq/kg |
Key to abbreviations
BP = British Pharmacopoeia
HPLC = High-pressure liquid chromatography
IR = Infrared spectrophotometry
PCBs = Polychlorinated biphenyls
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopoeia
ICP-OES = Inductively coupled plasma - optical emission spectrometry
ICP-MS = Inductively coupled plasma mass spectrometry