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    Chemistry

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    Also known as: 515-98-0, Lac-hydrin, Ammonium (+-)-lactate, Ammonium lactate [usan], Azanium;2-hydroxypropanoate, Propanoic acid, 2-hydroxy-, monoammonium salt
    Molecular Formula
    C3H9NO3
    Molecular Weight
    107.11  g/mol
    InChI Key
    RZOBLYBZQXQGFY-UHFFFAOYSA-N
    FDA UNII
    67M901L9NQ
    Ammonium Lactate
    A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed)
    Ammonium lactate is an alpha-Hydroxy Acid.
    1 2D Structure

    Ammonium Lactate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    azanium;2-hydroxypropanoate
    2.1.2 InChI
    InChI=1S/C3H6O3.H3N/c1-2(4)3(5)6;/h2,4H,1H3,(H,5,6);1H3
    2.1.3 InChI Key
    RZOBLYBZQXQGFY-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(C(=O)[O-])O.[NH4+]
    2.2 Other Identifiers
    2.2.1 UNII
    67M901L9NQ
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2 Hydroxypropanoic Acid

    2. 2 Hydroxypropionic Acid

    3. 2-hydroxypropanoic Acid

    4. 2-hydroxypropionic Acid

    5. D Lactic Acid

    6. D-lactic Acid

    7. L Lactic Acid

    8. L-lactic Acid

    9. Lactate

    10. Lactate, Ammonium

    11. Lactic Acid

    12. Propanoic Acid, 2-hydroxy-, (2r)-

    13. Propanoic Acid, 2-hydroxy-, (2s)-

    14. Sarcolactic Acid

    2.3.2 Depositor-Supplied Synonyms

    1. 515-98-0

    2. Lac-hydrin

    3. Ammonium (+-)-lactate

    4. Ammonium Lactate [usan]

    5. Azanium;2-hydroxypropanoate

    6. Propanoic Acid, 2-hydroxy-, Monoammonium Salt

    7. Lactate (monoammonium)

    8. Lactic Acid Ammonium Salt

    9. 2-hydroxypropanoic Acid Monoammonium Salt

    10. 67m901l9nq

    11. Lac Hydrin

    12. Bms-186091

    13. Lachydrin

    14. Ammonium Lactate (usan)

    15. Propanoic Acid, 2-hydroxy-, Ammonium Salt (1:1)

    16. Amlactin

    17. Laclotion

    18. (+/-)-ammonium Lactate; Bms 186091; Lac-hydrin; W 1001-10

    19. Kerasal Al

    20. Ammonium 2-hydroxypropanoate

    21. Einecs 208-214-8

    22. 52003-58-4

    23. Bms 186091

    24. Unii-67m901l9nq

    25. Lac-hydrin (tn)

    26. Ammonium2-hydroxypropanoate

    27. Schembl36407

    28. Ammonium Lactate [mi]

    29. Ammonium Lactate [inci]

    30. Ammonium Lactate [vandf]

    31. Ammonium-l-2-hydroxy-propionate

    32. Dtxsid3052808

    33. Propanoic Acid, 2-hydroxy-, Monoammonium Salt, (+-)-

    34. Ammonium (+/-)-lactate

    35. Ammonium Lactate [mart.]

    36. Lactic Acid Ammonium Salt (inn)

    37. Ammonium Lactate [who-dd]

    38. Hms3264p05

    39. Ammonium Lactate [orange Book]

    40. Ccg-213638

    41. Db06768

    42. Nsc 760427

    43. Db-071380

    44. D02920

    45. 515-98-052003-58-4(replacedby515-98-0)

    46. Propanoic Acid, 2-hydroxy-, Monoammonium Salt, (+/-)-

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 107.11 g/mol
    Molecular Formula C3H9NO3
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count0
    Exact Mass107.058243149 g/mol
    Monoisotopic Mass107.058243149 g/mol
    Topological Polar Surface Area61.4 Ų
    Heavy Atom Count7
    Formal Charge0
    Complexity53.5
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameAmmonium lactate
    PubMed HealthAmmonium Lactate (On the skin)
    Drug ClassesAntipruritic
    Drug LabelAmmonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4.Ingredients: Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light min...
    Active IngredientAmmonium lactate
    Dosage FormLotion; Cream
    RouteTopical
    Strengtheq 12% base
    Market StatusPrescription
    CompanyWatson Labs; Perrigo New York; Taro

    2 of 4  
    Drug NameLac-hydrin
    PubMed HealthAmmonium Lactate (On the skin)
    Drug ClassesAntipruritic
    Drug Label*Lac-Hydrin is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Lac-Hydrin 12% (ammonium lactate) Cream also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light minera...
    Active IngredientAmmonium lactate
    Dosage FormCream; Lotion
    RouteTopical
    Strengtheq 12% base
    Market StatusPrescription
    CompanyRanbaxy

    3 of 4  
    Drug NameAmmonium lactate
    PubMed HealthAmmonium Lactate (On the skin)
    Drug ClassesAntipruritic
    Drug LabelAmmonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4.Ingredients: Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light min...
    Active IngredientAmmonium lactate
    Dosage FormLotion; Cream
    RouteTopical
    Strengtheq 12% base
    Market StatusPrescription
    CompanyWatson Labs; Perrigo New York; Taro

    4 of 4  
    Drug NameLac-hydrin
    PubMed HealthAmmonium Lactate (On the skin)
    Drug ClassesAntipruritic
    Drug Label*Lac-Hydrin is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Lac-Hydrin 12% (ammonium lactate) Cream also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light minera...
    Active IngredientAmmonium lactate
    Dosage FormCream; Lotion
    RouteTopical
    Strengtheq 12% base
    Market StatusPrescription
    CompanyRanbaxy

    4.2 Drug Indication

    For the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Lactic acid is an alpha-hydroxy acid. It is a normal constituent of tissues and blood. The alpha-hydroxy acids (and their salts) may act as humectants when applied to the skin. This property may influence hydration of the stratum corneum. In addition, lactic acid, when applied to the skin, may act to decrease corneocyte cohesion.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    AMMONIUM LACTATE
    5.2.2 FDA UNII
    67M901L9NQ
    5.2.3 Pharmacological Classes
    Acidifying Activity [MoA]
    5.3 Absorption, Distribution and Excretion

    Absorption

    In vitro study of percutaneous absorption of ammonium lactate lotion, 12% using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours.

    5.4 Mechanism of Action

    Unknown.

    API SUPPLIERS

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    Seqens

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    DMF Review : Reviewed

    Rev. Date : 2023-11-02

    Pay. Date : 2023-10-30

    DMF Number : 12003

    Submission : 1996-06-17

    Status : Active

    Type : II

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    Pfanstiehl

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    Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12612

    Submission : 1997-08-05

    Status : Active

    Type : II

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    Pfanstiehl

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    Chattem Chemicals, Inc

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    Chattem Chemicals, Inc

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-08-15

    Pay. Date : 2023-07-12

    DMF Number : 13843

    Submission : 1998-11-12

    Status : Active

    Type : II

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    INOLEX CHEMICAL CO

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    INOLEX CHEMICAL CO

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5130

    Submission : 1983-09-30

    Status : Active

    Type : II

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    Corbion

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    Corbion

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11075

    Submission : 1994-09-13

    Status : Inactive

    Type : II

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    GREAT-5 INTERNATIONAL INC

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    GREAT-5 INTERNATIONAL INC

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    Seqens

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    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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    Ammonium Lactate

    About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...

    Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling up and manufacturing drug substances from the pre-clinical phase to the commercial phase. It offers a large portfolio of APIs and proprietary products. Seqens also develops custom solutions and ingredients for the most demanding industries, such as healthcare, electronics and cosmetics. Its unique range of technologies enables it to manufacture complex molecules for small- and large-scale demands. It operates 24 industrial plants and 10 R&D centres across the globe.
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    Pfanstiehl

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    Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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    Ammonium Lactate

    About the Company : Transform your biologic formulations with Pfanstiehl, the industry leader in High-Purity Low Endotoxin Low Metals Parenteral grade excipient manufacturing. Our expertise spans isol...

    Transform your biologic formulations with Pfanstiehl, the industry leader in High-Purity Low Endotoxin Low Metals Parenteral grade excipient manufacturing. Our expertise spans isolation, purification, custom synthesis, and scale-up development, ensuring the highest quality injectable formulation ingredients. Whether you need gram-scale quantities or multi-ton batches, trust Pfanstiehl for the highest quality injectable grade excipients available. The leading pharmaceutical companies worldwide use Pfanstiehl excipients for their unmatched purity, lowest endotoxin, and minimal trace metals. Partner with us to elevate your biologics formulations
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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707676200,"product":"FG0216 AMMONIUM LACTATE,BATCH:K\/NP\/7063-001","address":"8\/46,DR.BALIGA NAGAR,JASMIN MILL","city":"BOMBAY ,MAHARASTHRA","supplier":"PHARMA LINKS.","supplierCountry":"INDIA","foreign_port":"KATHMANDU","customer":"UNILEVER NEPAL LIMITED","customerCountry":"NEPAL","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"939.8","totalValueFC":"283.2","currency":"INR","unitRateINR":939.83000000000004,"date":"12-Feb-2024","totalValueINR":"23495.75","totalValueInUsd":"283.2","indian_port":"Raxaul","hs_no":"29181190","bill_no":"7466985","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Raxaul","supplierAddress":"8\/46,DR.BALIGA NAGAR,JASMIN MILL, BOMBAY ,MAHARASTHRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707676200,"product":"AMMONIUM LACTATE CAS NO:515 98 0","address":"NO.12-13-705\/7\/A B\/8\/A B\/201,","city":"HYDERABAD, AP.","supplier":"WAVELENGTH PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"CHICAGO","customer":"PADAGIS US LLC","customerCountry":"UNITED STATES","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"14.2","totalValueFC":"20649.8","currency":"USD","unitRateINR":1142.2590066666667,"date":"12-Feb-2024","totalValueINR":"1713388.51","totalValueInUsd":"20649.8","indian_port":"Hyderabad ICD","hs_no":"29189990","bill_no":"7463690","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad ICD","supplierAddress":"NO.12-13-705\/7\/A B\/8\/A B\/201,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1655663400,"product":"AMMONIUM LACTATE (TEST LIC : TL\/AZ\/22\/000083) FOR R&D PURPOSE NOT FOR SALE","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"WAVELENGTH PHARMACEUTICALS","supplierCountry":"ISRAEL","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"49.70","actualQuantity":"49.7","unit":"KGS","unitRateFc":"52","totalValueFC":"2615.4","currency":"USD","unitRateINR":"4105.4","date":"20-Jun-2022","totalValueINR":"204038.38","totalValueInUsd":"2615.4","indian_port":"BOMBAY AIR","hs_no":"29181190","bill_no":"9199513","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690309800,"product":"AMMONIUM LACTATE (TL NO: TL\/AZ\/22\/002141) FOR R&D PURPOSE NOT FOR SALE","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"WAVELENGTH PHARMACEUTICALS","supplierCountry":"ISRAEL","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"600.00","actualQuantity":"600","unit":"KGS","unitRateFc":"38.3","totalValueFC":"23210.8","currency":"USD","unitRateINR":"3179.6","date":"26-Jul-2023","totalValueINR":"1907684.121","totalValueInUsd":"23210.8","indian_port":"BOMBAY AIR","hs_no":"29181190","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724437800,"product":"PURASAL NH\/COS (AMMONIUM LACTATE)","address":"101-102-103\/D,SHYAM KAMAL,OPP.","city":"VILE-PARLE-E,MUMBAI. MAHARASHTRA","supplier":"PURAC ASIA PACIFIC ","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"PIOMA CHEMICALS","customerCountry":"INDIA","quantity":"800.00","actualQuantity":"800","unit":"KGS","unitRateFc":"5.9","totalValueFC":"4790.9","currency":"USD","unitRateINR":"502.3","date":"24-Aug-2024","totalValueINR":"401849.6","totalValueInUsd":"4790.9","indian_port":"JNPT","hs_no":"29181110","bill_no":"5217872","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"3 INTERNATIONAL BUSINESS PARK #06-19, NORDIC, EUROPEAN CENTRE SINGAPORE , , SINGAPORE SINGAPORE","customerAddress":"101-102-103\/D,SHYAM KAMAL,OPP."}]
    20-Jun-2022
    24-Aug-2024
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    DOSAGE - LOTION;TOPICAL - EQ 12% BASE **Feder...DOSAGE - LOTION;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19155

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    DOSAGE - CREAM;TOPICAL - EQ 12% BASE **Federa...DOSAGE - CREAM;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20508

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