Ammonium Chloride India Manufacturer; Ammonium Chloride IP BP USP

Ammonium Chloride - Clinical Pharmacology

The ammonium ion (NH4+) in the body plays an important role in the maintenance of acid-base balance. The kidney uses ammonium (NH4+) in place of sodium (Na+) to combine with fixed anions in maintaining acid-base balance, especially as a homeostatic compensatory mechanism in metabolic acidosis.

When a loss of hydrogen ions (H+) occurs and serum chloride (Cl−) decreases, sodium is made available for combination with bicarbonate (HCO3−). This creates an excess of sodium bicarbonate (NaHCO3) which leads to a rise in blood pH and a state of metabolic alkalosis.

The therapeutic effects of Amm. Cloride depend upon the ability of the kidney to utilize ammonia in the excretion of an excess of fixed anions and the conversion of ammonia to urea by the liver, thereby liberating hydrogen (H+) and chloride (Cl−) ions into the extracellular fluid.

The acidification properties of ammonium chloride are caused by its dissociation into chloride and ammonium ions in vivo. The ammonium cation is converted by the liver to urea with the release of a hydrogen ion. This ion combines with bicarbonate to form water and carbon dioxide. In the extracellular fluid, chloride ions combine with fixed bases and decrease the alkaline reserves in the body. The net effects are decreased serum bicarbonate levels and a decrease in blood and urine pH.

The excess chloride ions presented to the kidney, are not completely reabsorbed by the tubules and are excreted with cations (principally sodium) and water. This diuretic effect is usually compensated for by the kidneys after a few days of therapy.

The veterinary indications for ammonium chloride are as a urinary acidifying agent to help prevent and dissolve certain types of uroliths (e.g., struvite), to enhance renal excretion of some types of toxins (e.g., strontium) or drugs (e.g., quinidine), or to enhance the efficacy of certain antimicrobials (e.g., chlortetracycline, methenamine mandelate, nitrofurantoin, oxytetracycline, penicillin G or tetracycline) when treating urinary tract infections. Ammonium chloride has also been used intravenously for the rapid correction of metabolic alkalosis.

Indications and Usage for Ammonium Chloride

Ammonium Chloride Injection, USP, after dilution in isotonic sodium chloride injection, may be indicated in the treatment of patients with (1) hypochloremic states and (2) metabolic alkalosis.

Contraindications

Ammo. Chlo. is contraindicated in patients with severe hepatic disease as ammonia may accumulate and cause toxicity. In general, it should not be administered to uremic patients as it may intensify the metabolic acidosis already existing in some of these patients. It should not be used alone in patients with severe renal insufficiency and metabolic alkalosis secondary to vomiting hydrochloric acid as sodium depletion can occur. In these cases, sodium chloride repletion with or without ammonium chloride administration should be performed to correct both sodium and chloride deficits. Ammonium chloride is contraindicated in patients with urate calculi or respiratory acidosis and high total CO2 and buffer base. It cannot alone correct hypochloremia with secondary metabolic alkalosis due to intracellular potassium chloride depletion. Potassium chloride must be administered to these patients.

It should not be administered when metabolic alkalosis due to vomiting of hydrochloric acid is accompanied by loss of sodium (excretion of sodium bicarbonate in the urine).

It is reported to be physically compatible with all commonly used IV replacement fluids and potassium chloride.

It is incompatible with: codeine phosphate, dimenhydrinate, methadone HCl, nitrofurantoin sodium, sulfisoxazole diolamine, and warfarin sodium. It is also reportedly incompatible with alkalis and their hydroxides.

Precautions

Patients receiving Ammo. Chlo. should be constantly observed for symptoms of ammonia toxicity (pallor, sweating, retching, irregular breathing, bradycardia, cardiac arrhythmias, local and general twitching, tonic convulsions and coma).

It should be used with caution in patients with high total CO2 and buffer base secondary to primary respiratory acidosis.

Intravenous administration should be slow to avoid local irritation and toxic effects.

When exposed to low temperatures, concentrated solutions of Ammonium Chloride may crystallize. If crystals are observed, the vial should be warmed to room temperature in a water bath prior to use.

Do not administer unless the solution is clear and seal is intact. Discard unused portion.

Pregnancy Category C:

Animal reproduction studies have not been conducted with this item. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.

Adverse Reactions

Rapid intravenous administration of Ammo. Cloride may be accompanied by pain or irritation at the site of injection or along the venous route.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia (from large volume diluent).

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Overdosage

Overdosage of Ammo. Cloride has resulted in a serious degree of metabolic acidosis, disorientation, confusion and coma. Should metabolic acidosis occur following overdosage, the administration of an alkalinizing solution such as sodium bicarbonate or sodium lactate will serve to correct the acidosis.

Ammonium Chloride Dosage and Administration

Ammonium Chloride Injection, USP is administered intravenously and must be diluted before use. Solutions for intravenous infusion should not exceed a concentration of 1% to 2% of NH4Cl.

Dosage is dependent upon the condition and tolerance of the patient. It is recommended that the contents of one to two vials (100 to 200 mEq) be added to 500 or 1000 mL of isotonic (0.9%) sodium chloride injection. The rate of intravenous infusion should not exceed 5 mL per minute in adults (approximately 3 hours for infusion of 1000 mL). Dosage should be monitored by repeated serum bicarbonate determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

CHARACTERISTIC	Technical	Pure	Extra Pure
Dry Basis Assay (NH4Cl)	98.5% min.	99.% min.	99.5% min.
Moisture	5% max.	1% max.	0.5% max.
Iron	50	20	5
Sulphate	0.1% max.	0.1% max.	0.015% max.
Residue on Ignition	0.9% max	0.5% max	0.3% max
pH of 2% Ammonium Chloride Solution	4.0-5.5	4.0-5.5	4.0-5.5
Matter insoluble in water	0.1% max.	0.01% max.	0.005% max.
Heavy Metals as Pb	5 ppm max	5 ppm max	1 ppm max.
Arsenic	5 ppm max	5 ppm max	1 ppm max.

Particulars	Ammonium Chloride Pure Grade Non-Caking
Appearance (NH4Cl)	White Crystalline Powder
Assay of (NH4Cl on Dry Basis)	99% min.
Moisture	1% max.
pH of 5% solution	4 to 6
Iron	25 ppm max.
Matter Insoluble in water	0.01% max.
Sulphate	0.1% max.
Packing	In 50 Kg HDPE bag with HMHDPE liner

DESCRIPTION	COLOURLESS CRYSTALS OR WHITE, CRYSTALLINE POWDER.

SOLUBILITY	FREELY SOLUBLE IN WATER; SPARINGLY SOLUBLE IN ETHANOL (95%).

STANDARD	CONTENT NOT LESS THAN 99.0% AND NOT MORE THAN 100.5% OF NH₄Cl CALCULATED WITH REFERENCE TO THE DRIED SUBSTANCE.

IDENTIFICATION	A 10% w/w SOLUTION GIVES THE REACTIONS OF AMMONIUM SALTS AND OF CHLORIDES.

CLARITY AND	A 10% w/w SOLUTION IS CLEAR & COLOURLESS.
COLOUR OF SOLN.

pH	BETWEEN 4.5 AND 6.0, DETERMINED IN A 5.0 W/V SOLUTION.

ARSENIC	NOT MORE THAN 4 PARTS PER MILLION.

HEAVY METALS	NOT MORE THAN 10 PARTS PER MILLION.

MAGNESIUM &	NOT MORE THAN 1%.
ALKALI SALTS

IRON	NOT MORE THAN 20 PARTS PER MILLION.

SULPHATE	NOT MORE THAN 150 PARTS PER MILLION.

SULPHATED ASH	NOT MORE THAN 0.1%.

CALCIUM	NOT MORE THAN 200 PARTS PER MILLION.

THIOCYANATE	TO PASS THE TEST.

LOSS ON DRYING	NOT MORE THAN 1%, DETERMINED ON 1 GM BY DRYING IN AN OVEN AT 105⁰C.

Particulars	BP Specification	Our Typical Product
Dry Basis Assay	99-100.5%	99.9%
Characteristics	Colourless Crystals or white crystalline powder; odourless	White, crystalline powder; odourless
Solubility	Soluble in 2.7 parts of water	Soluble in 2.7 parts of water
Identification	Yields the reactions characteristic of ammonium salts and of chlorides	Yields the reactions characteristic of ammonium salts and of chlorides
Acidity or alkalinity	To conform to specified test	Passes test
Clarity and Colour of Solution	Clear & colourless solution (10% w/v)	Clear & colourless solution (10% w/v)
Calcium	200 ppm	30 ppm
Heavy Metals	10 ppm	Nil
Iron	20 ppm	5 ppm
Bromide and iodide	To conform to specified test	Passes test
Sulphate	150 ppm	20 ppm
Loss on Drying	1%	0.05%
Sulphated Ash	0.1%	0.009%

Particulars	Our Typical Product	USP Specification
Dry Basis Assay	99.9%	99.5-100.5%
pH of 5% Solution	5.3	4.6-6
Sulphated Ash	0.009%	0.1% (residue on ignition)
Heavy Metals as Pb	Nil	0.001%
Loss on Drying	0.1%	0.5% (4 hours on silica gel)
Thiocyanate	Passes test	To pass the test

AMMONIUM CHLORIDE SALAMMONIAC

Applications