Phosphates Enema

Sodium Phosphates Enema

Phosphates Rectal Solution

Phosphates Enema is a rectal solution containing suitable quantities of either Anhydrous Sodium Dihydrogen Phosphate, Sodium Dihydrogen Phosphate Monohydrate, Sodium Dihydrogen Phosphate Dihydrate or Phosphoric Acid and either Anhydrous Disodium Hydrogen Phosphate, Disodium Hydrogen Phosphate Dodecahydrate or Disodium Hydrogen Phosphate Dihydrate in freshly boiled and cooled Purified Water. A suitable antimicrobial preservative may be included.

The composition of two established formulations is described below.

Sodium Dihydrogen Phosphate Dihydrate	160 g
Disodium Hydrogen Phosphate Dodecahydrate	60 g
Purified Water, freshly boiled and cooled	Sufficient to produce 1000 mL

A suitable antimicrobial preservative may be included.

Sodium Dihydrogen Phosphate Dihydrate	100 g
Disodium Hydrogen Phosphate Dodecahydrate	80 g
Purified Water, freshly boiled and cooled	Sufficient to produce 1000 mL

A suitable antimicrobial preservative may be included.

The enema complies with the requirements stated under Rectal Preparations and with the following requirements.

Formula A: 15.2 to 16.8% w/v; Formula B: 9.5 to 10.5% w/v; any other formulation: 95.0 to 105.0% of the stated amount.

Formula A: 5.6 to 6.4% w/v; Formula B: 7.5 to 8.5% w/v; any other formulation: 95.0 to 105.0% of the stated amount.

A. Yields the reactions characteristic of sodium salts, Appendix VI.

B. Yields the reactions characteristic of phosphates, Appendix VI.

The enema being examined is clear, Appendix IV A, and colourless, Appendix IV B, Method II.

pH, 5.0 to 6.2, Appendix V L.

To 20 mL add 80 mL of water and 25 g of sodium chloride and titrate with 0.5m sodium hydroxide VS using phenolphthalein solution R1 as indicator. Each mL of 0.5m sodium hydroxide VS is equivalent to 78.00 mg of NaH₂PO₄,2H₂O.

Titrate 50 mL with 0.5m hydrochloric acid VS using 2 mL of a mixture of 4 volumes of bromocresol green solution and 1 volume of methyl red solution as indicator and titrating to the colour indicative of pH 4.4. Each mL of 0.5m hydrochloric acid VS is equivalent to 179.0 mg of Na₂HPO₄,12H₂O.

The label states (1) where appropriate, that the enema is Formula A or Formula B; (2) for any formulation other than Formula A or B, the content in terms of the amount or equivalent of Sodium Dihydrogen Phosphate Dihydrate and Disodium Hydrogen Phosphate Dodecahydrate.