Table II: Pharmacopeial specifications for sodium lauryl sulfate.
Test JP 2001 PhEur 2005 USPNF 23
Unsulfated alcohols 44.0% — 44.0%
Nonesterified alcohols — 44.0% —
Total alcohols 559.0% — 559.0%
Organic volatile impurities — — +
Assay (as C12H25NaO4S) — 585.0% —
Stability and Storage Conditions
Cetostearyl alcohol; cetyl alcohol; magnesium lauryl sulfate; wax, anionic emulsifying.
Empirical formula: C12H26O4S·HMg
Smith BJ. SDS polyacrylamide gel electrophoresis of proteins.
Methods Mol Biol 1994; 32: 23–34.
Grant WM. Toxicology of the Eye, 2nd edn. Springfield, IL: Charles C Thomas, 1974: 964.
Chemical Name and CAS Registry Number
Sodium pyrosulfite [7681-57-4]
Empirical Formula and Molecular Weight
Applications in Pharmaceutical Formulation or Technology
Sodium metabisulfite usually contains small amounts of sodium sulfite and sodium sulfate.
Table I: Pharmacopeial specifications for sodium metabisulfite.
Test JP 2001 PhEur 2005 USPNF 23
Appearance of solution + + — pH (5% w/v solution) — 3.5–5.0 —
Arsenic 44 ppm 45 ppm 43 ppm Heavy metals 420 ppm 420 ppm 40.002% Selenium — — <0.005%
Assay (as Na2S2O5) — 95.0–100.5% —
Acidity/alkalinity: pH = 3.5–5.0 for a 5% w/v aqueous solution at 208C.
Melting point: sodium metabisulfite melts with decomposition at less than 1508C.
Osmolarity: a 1.38% w/v aqueous solution is isoosmotic with serum.
Table II: Solubility of sodium metabisulfite.
Solvent Solubility at 208C unless otherwise stated
Ethanol (95%) Slightly soluble
Stability and Storage Conditions
It is incompatible with phenylmercuric acetate when autoclaved in eye drop preparations.(6)
in the UK. Included in the Canadian List of Acceptable Non- medicinal Ingredients.
Potassium metabisulfite; sodium bisulfite; sodium sulfite.
Synonyms: E222; sodium hydrogen sulfite.
Appearance: white crystalline powder.
The EINECS number for sodium metabisulfite is 231-673-0.
Schroeter LC. Sulfurous acid salts as pharmaceutical antioxidants.
J Pharm Sci 1961; 50(11): 891–901.
Anonymous. Possible allergic-type reactions. FDA Drug Bull
Anonymous. Sulfites in drugs and food. Med Lett Drugs Ther
Baker GJ. Bronchospasm induced by bisulfite containing food and drugs. Med J Aust 1981; ii: 614–617.
Fwarog FJ, Leung DYM. Anaphylaxis to a component of isoethane. J Am Med Assoc 1982; 248: 2030–2031.
Wilkins JW, Greene JA, Weller JM. Toxicity of intraperitoneal bisulfite.
Clin Pharmacol Ther 1968; 9: 328–332.
BP: Anhydrous disodium hydrogen phosphate Disodium hydrogen phosphate
Disodium hydrogen phosphate dodecahydrate JP: Dibasic sodium phosphate
PhEur: Dinatrii phosphas anhydricus Dinatrii phosphas dihydricus Dinatrii phosphas dodecahydricus
Chemical Name and CAS Registry Number
Empirical Formula and Molecular Weight
Na2HPO4·xH2O where x = 0, 1, 2, 7, or 12.
Buffering agent; sequestering agent.
Applications in Pharmaceutical Formulation or Technology
Table I: Pharmacopeial specifications for sodium phosphate, dibasic(a).
Test JP 2001 PhEur 2005 USP 28
Insoluble substances — — 40.4%
Monosodium phosphate — 40.025 —
Heavy metals 410 ppm + 40.002%
Dihydrate — 19.5–21.0% 18.5–21.5%
Assay (dried basis) 598.0% 98.0–101.0% 98.0–100.5%
(a) PhEur 2005 (Suppl. 5.1) for the dodecahydrate.
pKa1 = 2.15 at 258C;(3) pKa2 = 7.20 at 258C; pKa3 = 12.38 at 258C.
Stability and Storage Conditions
The bulk material should be stored in an airtight container, in a cool, dry place.
associated with adverse effects. LD50 (rat, oral): 17 g/kg(7)
Dibasic potassium phosphate; sodium phosphate, monobasic; tribasic sodium phosphate.
Dibasic potassium phosphate Empirical formula: K2HPO4 Molecular weight: 174.15
Appearance: colorless or white, granular, hygroscopic powder.
Acidity/alkalinity: pH = 8.5–9.6 for a 5% w/v aqueous solution at 258C.
Osmolarity: a 2.08% w/v aqueous solution of dibasic potassium phosphate is isoosmotic with serum.
Solubility: freely soluble in water; very slightly soluble in ethanol (95%).
Empirical formula: Na3PO4·xH2O
Molecular weight: 163.94 for the anhydrous material
380.06 for the dodecahydrate (12H2O)
CAS number: [7601-54-9] for the anhydrous material.
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