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British Pharmacopeia (BP) US Pharmacopeia (USP) European Pharmacopeia (EP)

Glyceryl Trinitrate Solution:

EP:

Glyceryl trinitrate solution is an ethanolic solution of glyceryl trinitrate.

Glyceryl Trinitrate solution contains not less than 9.85 g/l and not more than 101.0 g/l of propane-1,2,3-triol trinitrate and not less than 98.5 per cent and not more than 101.0 per cent of the declared content of glyceryl trinitrate stated on the label.

 

Diluted Glyceryl Trinitrate:

USP:

Dilted Nitroglycerin is a mixture of nitroglycerin with lactose, dextrose, alcohol, propylene glycol, or other suitable inert excipient to permit safe handling.

Diluted Nitroglycerin contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C3H5N3O9.

 

Glyceryl Trinitrate Tablets:

BP:

Glyceryl Trinitrate Tablets are made with Mannitol as the basis and may be prepared by adding Glyceryl Trinitrate Solution of an appropriate concentration to dried granules of Mannitol, mixing intimately, drying at a temperature not exceeding 50¢X or without heating for not more than 4 hours and compressing.

Glyceryl Trinitrate Tablets contain not less than 85.0 percent and not more than 115.0 percent of the prescribed or stated amount of C3H5N3O9.

USP:

Nitroglycerin Tablets contain not less than 90.0 percent and not more than 115.0 percent of the labeled amount of C3H5N3O9.

 

Glyceryl Trinitrate Sublingual Spray:

BP:

Glyceryl Trinitrate Sublingual Spray contains Glyceryl Trinitrate Solution in a suitable vehicle either in a suitable pressurised container or in a container fitted with a spray device. Glyceryl Trinitrate Sublingual Spray contain not less than 80.0 percent and not more than 120.0% of the amount of C3H5N3O9 stated to be delivered per metered dose.

 

Glyceryl Trinitrate Transdermal Patches:

BP:

Glyceryl Trinitrate Transdermal Patches contain glyceryl trinitrate in a suitable matrix or reservoir presentation. They are prepared from Glyceryl Trinitrate Solution

Glyceryl Trinitrate Transdermal Patches contain not less than 90.0 percent and not more than 115.0% of the prescribed or stated amount of C 3 H 5 N 3 O 9 .

 

Glyceryl Trinitrate Ointment

USP:

Nitroglycerin Ointment is diluted Nitroglycerin in a suitable ointment base.

Nitroglycerin Ointment contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of C 3 H 5 N 3 O 9 .

 

Glyceryl Trinitrate Injection:

USP:

Nitroglycerin Injection is a sterile solution prepared from Diluted Nitroglycerin; the solvent may contain alcohol, propylene glycol, and water for injection.

Nitroglycerin Injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C3H5N3O9.

 

 

Tak Cheung LAW