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1. Ammoniac, Sal
2. Chloride, Ammonium
3. Sal Ammoniac
1. 12125-02-9
2. Salmiac
3. Sal Ammoniac
4. Ammonium Muriate
5. Ammoniumchlorid
6. Darammon
7. Ammonium Chloride ((nh4)cl)
8. Ammoniumchloride
9. Nh4cl
10. Amchlor
11. Ammoneric
12. 01q9pc255d
13. Ammoniumklorid
14. Chlorammonic
15. Salammonite
16. Ammonchlor
17. Chloramon
18. Elektrolyt
19. Sal Ammonia
20. Ammon Chlor
21. Ammonii Chloridum
22. Ammonium Chloratum
23. Cloruro De Amonio
24. Muriate Of Ammonia
25. Gen-diur (spain)
26. Ammonium Chloride Fume
27. Chlorammonic [france]
28. Chlorid Amonny [czech]
29. Chlorid Ammonia
30. Chlorid Amonny
31. Ammoniumchlorid [german]
32. Chlorid Ammonia [czech]
33. Ammonium Chloride Tablets
34. Ammonium Chloride Injection
35. Ccris 7262
36. Hsdb 483
37. Einecs 235-186-4
38. Ammonium Chloride 2.14%
39. Ammonium Chloride [usp:jan]
40. Unii-01q9pc255d
41. Ammonium Chlorid
42. Ammonium Choride
43. Ammonium Cloride
44. Amonium Chloride
45. Ai3-08937
46. Chloride Ammonium
47. Ammoniurn Chloride
48. Amrnonium Chloride
49. Arnmonium Chloride
50. Ammonium Chloride (nh4)(hcl2))
51. Ammonia Hydrochloride
52. Conclyte-a (tn)
53. Ammonium Chloride In Plastic Container
54. Ammonia Hydrochloride-
55. Ammonium Chloride Salt
56. Ammonium Chloride 0.9% In Normal Saline
57. Quaternary Ammonium Salt
58. Ec 235-186-4
59. Quaternary Ammonium Chloride
60. Ammonium Chloride Acs Grade
61. Ammonium Chloride (jan/usp)
62. Ammonium Chloride [ii]
63. Ammonium Chloride [mi]
64. Ammonium Chloride, Puratronic?
65. Ammonium Chloride [fcc]
66. Ammonium Chloride [jan]
67. Ammonium Chloride [hsdb]
68. Ammonium Chloride [inci]
69. Dtxsid0020078
70. Ammonium Chloride [vandf]
71. Ammonium Chloride [mart.]
72. Ammonium Muriaticum [hpus]
73. Ammonium Chloride [usp-rs]
74. Ammonium Chloride [who-dd]
75. Bcp29846
76. Ammonium Chloride, Biochemical Grade
77. Mfcd00143604
78. Akos015833109
79. Ammonium Chloride [green Book]
80. Ammonium Chloride [orange Book]
81. Db06767
82. Ammonium Chloride [ep Monograph]
83. Ammonium Chloride [usp Monograph]
84. Ammonium Chloride, 0.5m Aqueous Solution
85. Ft-0622314
86. Ai3-08937;chloride, Ammonium;ammoniac, Sal
87. Ammonia Nitrogen Standard Solution, 1000 Ppm
88. D01139
89. Ammonium Chloride, Trace Metals Grade, 99.97%
90. Ammonium, Ion Chromatography Standard Solution, Specpure?, Nh4+ 1000?g/ml
91. Ammonium Ion Chromatography Standard Solution, Ready-to-use, Traceable To Nist, In H2o
92. Buffer Solution, Ph 6.86 (?0.01 At 25?c), No Color, Specpure?, Nist Traceable
93. Ammonium Ion Solution For Ise, 0.1 M Nh4+, Analytical Standard (for Ion-selective Electrodes)
94. Ammonium Ion Solution For Ise, 1000 Mg/kg N, Analytical Standard (for Ion-selective Electrodes)
| Molecular Weight | 53.49 g/mol |
|---|---|
| Molecular Formula | ClH4N |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 1 |
| Rotatable Bond Count | 0 |
| Exact Mass | 53.0032268 g/mol |
| Monoisotopic Mass | 53.0032268 g/mol |
| Topological Polar Surface Area | 1 Ų |
| Heavy Atom Count | 2 |
| Formal Charge | 0 |
| Complexity | 0 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Ammonium chloride in plastic container |
| Active Ingredient | Ammonium chloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 5meq/ml |
| Market Status | Prescription |
| Company | Hospira |
| 2 of 2 | |
|---|---|
| Drug Name | Ammonium chloride in plastic container |
| Active Ingredient | Ammonium chloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 5meq/ml |
| Market Status | Prescription |
| Company | Hospira |
Mesh Heading: diuretics, expectorants
National Library of Medicine, SIS; ChemIDplus Record for Ammonium chloride (12125-02-9). Available from, as of April 13, 2006: https://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp
Ammonium chloride is used as a systemic acidifier in patients with metabolic alkalosis resulting from chloride loss following vomiting, gastric suction, gastric fistula drainage, and pyloric stenosis. Ammonium chloride also has been used in the treatment of diuretic-induced chloride depletion. A solution containing isotonic or hypotonic sodium chloride with potassium chloride usually has been more effective than ammonium chloride in hypokalemic patients. Ammonium chloride also has been used to treat alkalosis resulting from excessive use of alkalinizing drugs.
American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 2776
Ammonium chloride has been used in a variety of conditions to induce incipient acidosis for the purpose of promoting diuresis, particularly in edematous conditions associated with hypochloremia. Ammonium chloride had limited value as a diuretic when used alone because of its limited period of effectiveness, but the drug has been useful when administered alone or in combination with a xanthine diuretic (e.g., caffeine, pamabrom) for short-term therapy to relieve temporary water-weight gain, edema, bloating, and/or full feeling associated with premenstrual and menstrual periods. Ammonium chloride also has been used for its diuretic effect in Meniere's syndrome.
American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 2776
MEDICATION (VET): As urinary acidifier, and to increase its rate of flow when it is given in large doses. Reduces incidence of urinary calculi in cattle and sheep. Increases intestinal tract acidity, thus increases calcium absorption and this is utilized in preventing milk fever in cattle. Stimulant and liquefier of bronchial secretions.
Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 16
For more Therapeutic Uses (Complete) data for AMMONIUM CHLORIDE (11 total), please visit the HSDB record page.
Ammonium salts are contra-indicated in patients with hepatic or renal impairment.
SWEETMAN, S.C. (ed.) Martindale-The Complete Drug Reference. 36th ed. London: The Pharmaceutical Press, 2009., p. 1551
Patients receiving ammonium chloride should be closely monitored for signs and symptoms of ammonia toxicity such as pallor, sweating, irregular breathing, vomiting, bradycardia, cardiac arrhythmias, local or generalized twitching, asterixis, tonic seizures, and coma.
American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 2777
Sustained correction of hypochloremia cannot be achieved by administering ammonium chloride alone in patients with secondary metabolic alkalosis resulting from intracellular potassium depletion; concomitant administration of potassium chloride is necessary in such patients.
American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 2777
Ammonium chloride should be administered with caution to patients with pulmonary insufficiency or cardiac edema. The drug should not be used in patients with primary respiratory acidosis and high total carbon dioxide and buffer base.
American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 2777
For more Drug Warnings (Complete) data for AMMONIUM CHLORIDE (12 total), please visit the HSDB record page.
1. Expectorant in cough syrups. 2. 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. The therapeutic effects of Ammonium Chloride 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. 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.
Systemic acidifier. In liver ammonium chloride is converted into urea with the liberation of hydrogen ions ( which lowers the pH) and chloride.
B - Blood and blood forming organs
B05 - Blood substitutes and perfusion solutions
B05X - I.v. solution additives
B05XA - Electrolyte solutions
B05XA04 - Ammonium chloride
G - Genito urinary system and sex hormones
G04 - Urologicals
G04B - Urologicals
G04BA - Acidifiers
G04BA01 - Ammonium chloride
Absorption
Completely absorbed within 36 h. In healthy persons, absorption of ammonium chloride given by mouth was practically complete. Only 1 to 3% of the dose was recovered in the feces.
Route of Elimination
Excretion: Urine
Volume of Distribution
Data not found.
Clearance
Data not found.
From human incidentally exposures it was learnt that following oral administration, ammonium chloride is rapidly absorbed from the GI tract, complete absorption occurring within 3 -6 hours. Only 1 -3% of the dose was recovered in the feces. Substantial first pass metabolism occurs in the liver. For animals, after repeated oral administration, ammonium chloride enters readily the body and main targets for its toxicity are kidneys.
European Chemicals Agency (ECHA); Registered Substances, Ammonium chloridee (CAS Number: 12125-02-9) (EC Number: 235-186-4) (October 28, 2014). Available from, as of February 10, 2015: https://echa.europa.eu/en/information-on-chemicals
Ammonium chloride is effectively absorbed from the gastrointestinal tract ... . In healthy persons, absorption of ammonium chloride given by mouth was practically complete. Only 1 to 3% of the dose was recovered in the feces.
Reynolds, J.E.F., Prasad, A.B. (eds.) Martindale-The Extra Pharmacopoeia. 28th ed. London: The Pharmaceutical Press, 1982., p. 687
Following oral administration, ammonium chloride is rapidly absorbed from the GI tract, complete absorption occurring within 3-6 hours. However, an oral dosage form of ammonium chloride is no longer commercially available in the US.
American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 2777
Oral administration of ammonium chloride to healthy male and female volunteers at 9 mg/kg bw produced transient increases in blood ammonia in about half of the subjects. Patients with cirrhosis showed a greater and more prolonged increase over a higher baseline. This confirms substantial first pass metabolism in the liver.
European Chemicals Bureau; IUCLID Dataset, Ammonium chloride (12125-02-9) (2000 CD-ROM edition). Available from, as of July 17, 2006: https://esis.jrc.ec.europa.eu/
Ammonium ion is converted to urea in the liver; chloride ion replaces bicarbonate.
When ammonium ion is converted to urea, liberated hydrogen ion reacts with bicarbonate and other body buffers ... chloride ion displaces bicarbonate ion; latter is converted to carbon dioxide ... chloride load to kidneys is increased and appreciable amount escapes reabsorption along with equivalent amount of cation ... and isoosmotic quantity of water.
Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 862
The toxicity of ammonium chloride depends on the ammonia which enters the living organism and hence the cell. This substance is readily absorbed by the gastrointestinal tract, and utilized in the liver to form amino acids and proteins. When ammonium ions are converted to urea, liberated hydrogen ion reacts with bicarbonate ion to form water and carbon dioxide. The chloride ion displaces the bicarbonate ion. Chloride is loaded into the kidneys. The increased chloride concentration in the extracellular fluid produces an increased load to the renal tubules. Increase excretion of electrolytes and water causes loss of extracellular fluid and promotes the mobilization of edema fluid.
European Chemicals Agency (ECHA); Registered Substances, Ammonium chloridee (CAS Number: 12125-02-9) (EC Number: 235-186-4) (October 28, 2014). Available from, as of February 10, 2015: https://echa.europa.eu/en/information-on-chemicals
/Ammonium chloride/ is metabolized in the liver to form urea and hydrochloric acid.
American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 2777
Male Sprague-Dawley rats gavaged with 1000 umol (15)N ammonium chloride each day for 5 days were found to excrete low, but significant amounts of excess (15)N nitrate in their urines on the five days of treatment and on the five subsequent days. A total of 0.28 + or - 0.03 umol excess (15)N nitrate (mean + or - SE) per rat was recovered which indicates that ammonia is converted to nitrate in a yield of approximately 0.0080%.
PMID:6690089 Saul RL, Archer MC; Carcinogenesis 5 (1): 77-81 (1984)
Unknown
Ammonium chloride increases acidity by increasing the amount of hydrogen ion concentrations. Ammonium chloride can be used as an expectorant due to its irritative action on the bronchial mucosa. This effect causes the production of respiratory tract fluid which in order facilitates the effective cough.
The acid-forming properties of ammonium chloride result from dissociation of the salt to an ammonium cation and a chloride anion. In patients with normal hepatic function, the ammonium cation is converted to urea by the liver and a hydrogen cation is released which reacts with a bicarbonate ion to form water and carbon dioxide. The chloride anion combines with fixed bases in the extracellular fluid, thereby reducing the alkaline reserve of the body. The net result is the displacement of bicarbonate ions by chloride anions. The displacement of bicarbonate by chloride alters the bicarbonate:carbonic acid ratio if the body and acidosis results. The increased chloride concentration in the extracellular fluid produces an increased load to the renal tubules and appreciable amounts of chloride anions escape reabsorption. These anions are excreted along with cations and water. Sodium is the principal cation excreted; however, potassium excretion may also be increased to some degree. By increasing the excretion of both extracellular electrolytes and water, ammonium chloride causes a net loss of extracellular fluid and promotes the mobilization of edema fluid.
American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 2777
API SUPPLIERS
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5824
Submission : 1985-05-23
Status : Inactive
Type : II
Certificate Number : R0-CEP 2021-326 - Rev 00
Issue Date : 2023-05-30
Type : Chemical
Substance Number : 7
Status : Valid
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ABOUT THIS PAGE
A Ammonium Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ammonium Chloride, including repackagers and relabelers. The FDA regulates Ammonium Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ammonium Chloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ammonium Chloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ammonium Chloride supplier is an individual or a company that provides Ammonium Chloride active pharmaceutical ingredient (API) or Ammonium Chloride finished formulations upon request. The Ammonium Chloride suppliers may include Ammonium Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ammonium Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ammonium Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Ammonium Chloride active pharmaceutical ingredient (API) in detail. Different forms of Ammonium Chloride DMFs exist exist since differing nations have different regulations, such as Ammonium Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ammonium Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Ammonium Chloride USDMF includes data on Ammonium Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ammonium Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ammonium Chloride suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ammonium Chloride Drug Master File in Korea (Ammonium Chloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ammonium Chloride. The MFDS reviews the Ammonium Chloride KDMF as part of the drug registration process and uses the information provided in the Ammonium Chloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ammonium Chloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ammonium Chloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ammonium Chloride suppliers with KDMF on PharmaCompass.
A Ammonium Chloride CEP of the European Pharmacopoeia monograph is often referred to as a Ammonium Chloride Certificate of Suitability (COS). The purpose of a Ammonium Chloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ammonium Chloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ammonium Chloride to their clients by showing that a Ammonium Chloride CEP has been issued for it. The manufacturer submits a Ammonium Chloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ammonium Chloride CEP holder for the record. Additionally, the data presented in the Ammonium Chloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ammonium Chloride DMF.
A Ammonium Chloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ammonium Chloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Ammonium Chloride suppliers with CEP (COS) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ammonium Chloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ammonium Chloride API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Ammonium Chloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Ammonium Chloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ammonium Chloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ammonium Chloride suppliers with NDC on PharmaCompass.
Ammonium Chloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Ammonium Chloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ammonium Chloride GMP manufacturer or Ammonium Chloride GMP API supplier for your needs.
A Ammonium Chloride CoA (Certificate of Analysis) is a formal document that attests to Ammonium Chloride's compliance with Ammonium Chloride specifications and serves as a tool for batch-level quality control.
Ammonium Chloride CoA mostly includes findings from lab analyses of a specific batch. For each Ammonium Chloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Ammonium Chloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Ammonium Chloride EP), Ammonium Chloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ammonium Chloride USP).
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