Drug Substance

The quality of Bharat Pharma’s drug substance Diluted Nitroglycerin not only conforms but also exceeds the specified standards of mentioned Pharmacopoeias w.r.t., Purity as well as Impurity profile. The purity of Nitroglycerin in the drug substance remains close to 100 % of label claim whereas total impurity profile remains near to 1/10th of the specified acceptable Pharmacopeia limit.

Drug Substance

IUPAC Name: 1,3 -dinitro oxy propan-2- yl nitrate

Pharmacological Name: Diluted Nitroglycerin IP/USP

Common Generic Name: Nitroglycerin, Glyceryl trinitrate (GTN) , Tri nitroglycerin

CAS Number of Nitroglycerin: 55-63-0

Category: Nitrate anti anginal; Vasodilator

Common inert diluents: Lactose monohydrate, Lactose anhydrous, Propylene glycol, Alcohol (Ethanol), Solvated adhesive of various grades as per customer’s demand

Pharmaceutical grade Nitroglycerin, which is a high potential explosive material, is diluted with solid or liquid inert medium for safe handling and making usable for manufacturing of pharmaceutical dosage forms. Diluted Nitroglycerin remain in the form of mixture or solution depending upon the nature of inert medium used for dilution Variety of delivery systems / dosage forms including sublingual tablets, sustained release tablets, injectables, oral sprays, ointment, gel and or transdermal patches are manufactured with Diluted Nitroglycerin.

Range

Neat Nitroglycerin is diluted in Lactose, Propylene glycol, Alcohol and other inert medium e.g. Solvated adhesive of grade as per the customer’s requirements.

Diluted Nitroglycerin IP/USP
10% w/w or 2% w/w Nitroglycerin in Lactose used to manufacture Nitroglycerin Tablets, Capsules and ointments

Diluted Nitroglycerin IP/USP
10% or 5% or 2% or 1% w/w Nitroglycerin in Propylene glycol used to manufacture IV injectable, Gel, Ointment and Oral Sprays

Nitroglycerin diluted in Solvated Adhesive
15% to 22% w/w Nitroglycerin in solvated adhesive used to manufacture transdermal patches

Packing

Container closure system for packing and pack size of Nitroglycerin drug substance is selected according to its physical form, hazardous nature, and customer’s demand.

Diluted Nitroglycerin in solid form is packed in triple poly lined wide mouth transport worthy HDPE drums.
Diluted Nitroglycerin in free flow liquid form is packed in leak proof packing using narrow mouth aluminum or HDPE container supported with bung /insert. For protection of container during transportation, packing is either wrapped with bubble sheet or placed in wooden box.

Diluted Nitroglycerin in viscous liquid from is packed in narrow mouth composite containers compatible with UN packing group, comprising of inner HDPE container and outer MS steel container closed with two HDPE bungs.

All the packing are protected with irreversible seal system.

Diluted Nitroglycerin IP/USP

(10% or 2% w/w Nitroglycerin in Lactose) in triple poly lined blue HDPE drum of 25 kg pack size

Diluted Nitroglycerin IP/USP

(10% or 5% or 2% or 1% w/w Nitroglycerin in Propylene glycol) in Aluminum containers of 5 kg, 10 kg , and 25 kg pack size

Nitroglycerin diluted in Solvated Adhesive

(15% to 22% w/w Nitroglycerin in solvated adhesive) in Composite containers (with inner container of HDPE and outer container of MS) of 20 kg, 50kg and 100 kg pack size