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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 Reference Price

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    [{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683052200,"product":"RM AMMONIUM LACTATE COSMETIC GRADE BATCH NUMBER AAMC23003V AAMC23004V AAMC23001R GREEN CARD NO 21173 DT 20 04 2022 VA","address":"NO.201, DEVAVRATA SECTOR 17, VASHI, NAVI MUMBAI - 400705. Contac","city":"NAVI MUMBAI","supplier":"SOLARA ACTIVE PHARMA SCIENCES","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"M S","customerCountry":"UNITED STATES","quantity":"8000.00","actualQuantity":"8000","unit":"KGS","unitRateFc":"13.5","totalValueFC":"102863","currency":"USD","unitRateINR":1058,"date":"03-May-2023","totalValueINR":"8464000","totalValueInUsd":"102863","indian_port":"JNPT","hs_no":"29181190","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"NO.201, DEVAVRATA SECTOR 17, VASHI, NAVI MUMBAI - 400705. Contac, NAVI MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700245800,"product":"AMMONIUM LACTATE","address":"NO.12-13-705\/7\/A B\/8\/A B\/201,","city":"HYDERABAD, AP.","supplier":"WAVELENGTH PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"PARIS","customer":"SEQENS","customerCountry":"FRANCE","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"32","totalValueFC":"180.1","currency":"USD","unitRateINR":2500,"date":"18-Nov-2023","totalValueINR":"15000","totalValueInUsd":"180.1","indian_port":"Hyderabad Air","hs_no":"29189990","bill_no":"5413984","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"NO.12-13-705\/7\/A B\/8\/A B\/201,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1661279400,"product":"PURASAL NH\/COS (AMMONIUM LACTATE)","address":"101-102-103\/D,SHYAM KAMAL,OPP. SAHAKARI BHANDAR,AGARWAL MARKET,","city":"VILE-PARLE-E,MUMBAI. MAHARASHTRA","supplier":"PURAC ASIA PACIFIC ","supplierCountry":"SPAIN","foreign_port":"NA","customer":"PIOMA CHEMICALS","customerCountry":"INDIA","quantity":"1600.00","actualQuantity":"1600","unit":"KGS","unitRateFc":"5.7","totalValueFC":"9178.4","currency":"USD","unitRateINR":"456.4","date":"24-Aug-2022","totalValueINR":"730296","totalValueInUsd":"9178.4","indian_port":"JNPT","hs_no":"29181110","bill_no":"2147757","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"101-102-103\/D,SHYAM KAMAL,OPP. SAHAKARI BHANDAR,AGARWAL MARKET,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1665599400,"product":"PURASAL NH\/COS (AMMONIUM LACTATE)","address":"101-102-103\/D,SHYAM KAMAL,OPP. SAHAKARI BHANDAR,AGARWAL MARKET,","city":"VILE-PARLE-E,MUMBAI. MAHARASHTRA","supplier":"PURAC ASIA PACIFIC ","supplierCountry":"SPAIN","foreign_port":"NA","customer":"PIOMA CHEMICALS","customerCountry":"INDIA","quantity":"1600.00","actualQuantity":"1600","unit":"KGS","unitRateFc":"5.5","totalValueFC":"8817.7","currency":"USD","unitRateINR":"453.5","date":"13-Oct-2022","totalValueINR":"725560","totalValueInUsd":"8817.7","indian_port":"JNPT","hs_no":"29181110","bill_no":"2855797","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"101-102-103\/D,SHYAM KAMAL,OPP. SAHAKARI BHANDAR,AGARWAL MARKET,"}]
    24-Aug-2022
    18-Nov-2023
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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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    ABOUT THIS PAGE

    Ammonium Lactate Manufacturers

    A Ammonium Lactate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ammonium Lactate, including repackagers and relabelers. The FDA regulates Ammonium Lactate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ammonium Lactate 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 Lactate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Ammonium Lactate Suppliers

    A Ammonium Lactate supplier is an individual or a company that provides Ammonium Lactate active pharmaceutical ingredient (API) or Ammonium Lactate finished formulations upon request. The Ammonium Lactate suppliers may include Ammonium Lactate API manufacturers, exporters, distributors and traders.

    click here to find a list of Ammonium Lactate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Ammonium Lactate USDMF

    A Ammonium Lactate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ammonium Lactate active pharmaceutical ingredient (API) in detail. Different forms of Ammonium Lactate DMFs exist exist since differing nations have different regulations, such as Ammonium Lactate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Ammonium Lactate DMF submitted to regulatory agencies in the US is known as a USDMF. Ammonium Lactate USDMF includes data on Ammonium Lactate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ammonium Lactate USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Ammonium Lactate suppliers with USDMF on PharmaCompass.

    Ammonium Lactate GMP

    Ammonium Lactate 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 Lactate 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 Lactate GMP manufacturer or Ammonium Lactate GMP API supplier for your needs.

    Ammonium Lactate CoA

    A Ammonium Lactate CoA (Certificate of Analysis) is a formal document that attests to Ammonium Lactate's compliance with Ammonium Lactate specifications and serves as a tool for batch-level quality control.

    Ammonium Lactate CoA mostly includes findings from lab analyses of a specific batch. For each Ammonium Lactate 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 Lactate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ammonium Lactate EP), Ammonium Lactate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ammonium Lactate USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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