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    Chemistry

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    Also known as: 2-hydroxypropanoic acid, Dl-lactic acid, 50-21-5, 2-hydroxypropionic acid, Milk acid, Lactate
    Molecular Formula
    C3H6O3
    Molecular Weight
    90.08  g/mol
    InChI Key
    JVTAAEKCZFNVCJ-UHFFFAOYSA-N
    FDA UNII
    3B8D35Y7S4
    Lactic Acid
    A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed)
    1 2D Structure

    Lactic Acid

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-hydroxypropanoic acid
    2.1.2 InChI
    InChI=1S/C3H6O3/c1-2(4)3(5)6/h2,4H,1H3,(H,5,6)
    2.1.3 InChI Key
    JVTAAEKCZFNVCJ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(C(=O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    3B8D35Y7S4
    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. Ammonium Lactate

    6. D Lactic Acid

    7. D-lactic Acid

    8. L Lactic Acid

    9. L-lactic Acid

    10. Lactate

    11. Lactate, Ammonium

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

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

    14. Sarcolactic Acid

    2.3.2 Depositor-Supplied Synonyms

    1. 2-hydroxypropanoic Acid

    2. Dl-lactic Acid

    3. 50-21-5

    4. 2-hydroxypropionic Acid

    5. Milk Acid

    6. Lactate

    7. Tonsillosan

    8. Racemic Lactic Acid

    9. Ordinary Lactic Acid

    10. Polylactic Acid

    11. Ethylidenelactic Acid

    12. Lactovagan

    13. Acidum Lacticum

    14. 26100-51-6

    15. Lactic Acid, Dl-

    16. Propanoic Acid, 2-hydroxy-

    17. Kyselina Mlecna

    18. Lacticum Acidum

    19. Dl-milchsaeure

    20. (+/-)-lactic Acid

    21. 598-82-3

    22. 1-hydroxyethanecarboxylic Acid

    23. Aethylidenmilchsaeure

    24. Alpha-hydroxypropionic Acid

    25. (rs)-2-hydroxypropionsaeure

    26. Fema No. 2611

    27. Kyselina 2-hydroxypropanova

    28. Propionic Acid, 2-hydroxy-

    29. Purac Fcc 80

    30. Purac Fcc 88

    31. Ccris 2951

    32. Hsdb 800

    33. (+-)-2-hydroxypropanoic Acid

    34. Lurex

    35. Lactic Acid, Tech Grade

    36. Propanoic Acid, Hydroxy-

    37. Sy-83

    38. Dl- Lactic Acid

    39. Nsc 367919

    40. 2-hydroxypropionicacid

    41. Ai3-03130

    42. Mfcd00004520

    43. Hipure 88

    44. Nsc-367919

    45. .alpha.-hydroxypropanoic Acid

    46. .alpha.-hydroxypropionic Acid

    47. (r)-2-hydroxy-propionic Acid;h-d-lac-oh

    48. Ins No.270

    49. E 270

    50. (+/-)-2-hydroxypropanoic Acid

    51. Chebi:78320

    52. Ins-270

    53. Poly(l-lactide)

    54. 3b8d35y7s4

    55. Lactic Acid Usp

    56. Ncgc00090972-01

    57. Lactic Acid, 1.0n Standardized Solution

    58. 2-hydroxy-propionic Acid

    59. Lactic Acid (natural)

    60. E-270

    61. Dsstox_cid_3192

    62. Alpha-hydroxypropanoic Acid

    63. C01432

    64. Dsstox_rid_76915

    65. Dsstox_gsid_23192

    66. Milchsaure [german]

    67. Lactic Acid [jan]

    68. Milchsaure

    69. Fema Number 2611

    70. Kyselina Mlecna [czech]

    71. 163894-00-6

    72. Cheongin Samrakhan

    73. Cas-50-21-5

    74. Cheongin Haewoohwan

    75. Cheongin Haejanghwan

    76. Kyselina 2-hydroxypropanova [czech]

    77. Einecs 200-018-0

    78. Einecs 209-954-4

    79. Lactic Acid [usp:jan]

    80. Epa Pesticide Chemical Code 128929

    81. Brn 5238667

    82. Lactasol

    83. 1-hydroxyethane 1-carboxylic Acid

    84. Biolac

    85. Unii-3b8d35y7s4

    86. 2-hydroxy-2-methylacetic Acid

    87. Lactide Polymer

    88. Chem-cast

    89. L- Lactic Acid

    90. Dl-polylactic Acid

    91. Lactate (tn)

    92. Lactic Acid,buffered

    93. 4b5w

    94. Propanoic Acid, (+-)

    95. Dl-lactic Acid, Racemic

    96. (.+/-.)-lactic Acid

    97. Ec 200-018-0

    98. Lactic Acid (7ci,8ci)

    99. Lactic Acid (jp17/usp)

    100. Lactic Acid, 85%, Fcc

    101. Lactic Acid, Racemic, Usp

    102. Nciopen2_000884

    103. Lactic Acid (+-)

    104. Dl-lactic Acid [mi]

    105. Lactic Acid, Unspecified Form

    106. Lactic Acid [who-ip]

    107. (rs)-2-hydroxypropanoic Acid

    108. Lactic Acid (fragrance Grade)

    109. Lacticum Acidum [hpus]

    110. Dl-lactic Acid (90per Cent)

    111. Chembl1200559

    112. Dtxsid7023192

    113. Lactic Acid, Natural, >=85%

    114. Bdbm23233

    115. L-lactic Acid Or Dl-lactic Acid

    116. Lactic Acid, 85 Percent, Fcc

    117. Lactic Acid, Dl- [ii]

    118. Dl-lactic Acid, ~90% (t)

    119. Dl-lactic Acid, Ar, >=88%

    120. Dl-lactic Acid, Lr, >=88%

    121. Dl- Lactic Acid [who-dd]

    122. Lactic Acid, 10 Percent Solution

    123. Hy-b2227

    124. Propanoic Acid, 2-hydroxy- (9ci)

    125. Tox21_111049

    126. Tox21_202455

    127. Tox21_303616

    128. Bbl027466

    129. Nsc367919

    130. Stl282744

    131. Akos000118855

    132. Akos017278364

    133. Tox21_111049_1

    134. Acidum Lacticum [who-ip Latin]

    135. Am87208

    136. Db04398

    137. Sb44647

    138. Sb44652

    139. Dl-lactic Acid, 85 % (w/w), Syrup

    140. Propanoic Acid,2-hydroxy-,(.+/-.)-

    141. 2-hydroxypropionic Acid, Dl-lactic Acid

    142. Ncgc00090972-02

    143. Ncgc00090972-03

    144. Ncgc00257515-01

    145. Ncgc00260004-01

    146. 26811-96-1

    147. Lactic Acid, 85 Percent, Reagent, Acs

    148. Db-071134

    149. Lactic Acid 100 Microg/ml In Acetonitrile

    150. Cs-0021601

    151. Ft-0624390

    152. Ft-0625477

    153. Ft-0627927

    154. Ft-0696525

    155. Ft-0774042

    156. L0226

    157. Lactic Acid Solution, Acs Reagent, >=85%

    158. Lactic Acid Solution, Usp, 88.0-92.0%

    159. Lactic Acid Solution, P.a., 84.5-85.5%

    160. Lactic Acid, Meets Usp Testing Specifications

    161. D00111

    162. F71201

    163. A877374

    164. Dl-lactic Acid, Saj First Grade, 85.0-92.0%

    165. Q161249

    166. Dl-lactic Acid, Jis Special Grade, 85.0-92.0%

    167. Lactic Acid Solution, Vetec(tm) Reagent Grade, 85%

    168. F2191-0200

    169. Bc10f553-5d5d-4388-bb74-378ed4e24908

    170. Lactic Acid, United States Pharmacopeia (usp) Reference Standard

    171. Lactic Acid, Pharmaceutical Secondary Standard; Certified Reference Material

    172. Dl-lactic Acid 90%, Synthetic, Meets The Analytical Specifications Of Ph. Eur.

    173. 152-36-3

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 90.08 g/mol
    Molecular Formula C3H6O3
    XLogP3-0.7
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count1
    Exact Mass90.031694049 g/mol
    Monoisotopic Mass90.031694049 g/mol
    Topological Polar Surface Area57.5 Ų
    Heavy Atom Count6
    Formal Charge0
    Complexity59.1
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Lactic acid is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of March 17, 2016: https://clinicaltrials.gov/ct2/results?term=lactic+acid&Search=Search

    (VET): Has been used as a caustic, and in dilute solutions to irrigate tissues; as an intestinal antiseptic and antiferment.

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Cambridge, UK: Royal Society of Chemistry, 2013., p. 990

    A 10% solution is used as a bactericidal agent on the skin of neonates. ... A 16.7% solution in flexible collodion is used to remove warts and small cutaneous tumors.

    Troy, D.B. (Ed); Remmington The Science and Practice of Pharmacy. 21 st Edition. Lippincott Williams & Williams, Philadelphia, PA 2005, p. 1087

    Acidulant

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Cambridge, UK: Royal Society of Chemistry, 2013., p. 990

    4.2 Drug Indication

    For use as an alkalinizing agent.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Lactic acid produces a metabolic alkalinizing effect.

    5.2 ATC Code

    G - Genito urinary system and sex hormones

    G01 - Gynecological antiinfectives and antiseptics

    G01A - Antiinfectives and antiseptics, excl. combinations with corticosteroids

    G01AD - Organic acids

    G01AD01 - Lactic acid

    5.3 Absorption, Distribution and Excretion

    L-lactic acid occurs in small quantities in the blood and muscle fluid of humans and animals; the concentration of lactic acid in these fluids increases after vigorous activity. L-lactic acid is also present in the liver, kidneys, thymus gland, human amniotic fluid, and other organs and body fluids.

    Cosmetic Ingredient Review Expert Panel; International Journal of Toxicology, 17 (Suppl.1): 1-203 (1998)

    A primed infusion study was performed /in humans/ using radioactive L-lactic acid. The virtual volume of distribution of lactate was 49.4% of body weight. The lactate pool size and turnover time were estimated as 0.029 g/kg and 18.4 min, respectively.

    Cosmetic Ingredient Review Expert Panel; International Journal of Toxicology, 17 (Suppl.1): 1-203 (1998)

    In the body, lactate is distributed equivalently to, or slightly less than, total body water. It diffuses readily across cell membranes, primarily by passive transport; under certain conditions, the distribution could be uneven or the lactate pool could consist of several smaller pools with differing rate constants.

    Cosmetic Ingredient Review Expert Panel; International Journal of Toxicology, 17 (Suppl.1): 1-203 (1998)

    The percutaneous absorption of topically applied 5% [14C]-lactic acid in an oil-in-water cream was measured using rats. After 3 days, 50% of the applied lactic acid had penetrated the skin.

    Cosmetic Ingredient Review Expert Panel; International Journal of Toxicology, 17 (Suppl.1): 1-203 (1998)

    For more Absorption, Distribution and Excretion (Complete) data for LACTIC ACID (6 total), please visit the HSDB record page.

    5.4 Metabolism/Metabolites

    ... Propylene glycol ... is oxidized to lactic acid or pyruvic acid by two pathways. These two metabolites are then used by the body as sources of energy either by oxidation through the tricarboxylic acid cycle or by generation of glycogen through the glycolytic pathway.

    Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. V7 31

    Lactic acid diffuses through muscle tissue and is transported to the liver in the bloodstream. In the liver, it is converted to glucose by gluconeogenesis. Lactic acid can also be further catabolized in the lactic acid cycle (also known as the Cori cycle).

    Joint FAO/WHO Expert Committee on Food Additives; WHO Food Additives Ser 48: Lactic acid (2002). Available from, as of April 19, 2006: https://www.inchem.org/documents/jecfa/jecmono/v48je16.htm

    L-lactic acid is a normal metabolic intermediate produced by most mammalian cells and other organisms, such as bacteria; it is metabolized in preference to D-lactic acid in man, dogs, and rats. Lactic acid is converted to pyruvic acid by lactic acid dehydrogenase.

    Cosmetic Ingredient Review Expert Panel; International Journal of Toxicology, 17 (Suppl.1): 1-203 (1998)

    In animals, lactate that is generated by anaerobic metabolism can be transported to other more aerobic tissues, such as the liver, where it can be reconverted to pyruvate. The pyruvate can then be further metabolized, reconverted to carbohydrate material as free glucose, or stored as glycogen.

    Cosmetic Ingredient Review Expert Panel; International Journal of Toxicology, 17 (Suppl.1): 1-203 (1998)

    For more Metabolism/Metabolites (Complete) data for LACTIC ACID (8 total), please visit the HSDB record page.

    5.5 Mechanism of Action

    Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

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FORT GARDEN,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747161000,"product":"904053 LACTIC ACID 80 NAT (RAW MATERIAL) 904053 LACTIC ACID 80 NAT (RAW MATERIAL)","address":"NOVELL HOUSE RD NO 13 MIDC MAROL","city":"MUMBAI, MAHARASHTRA","supplier":"FIRMENICH S A","supplierCountry":"CHINA","foreign_port":"GENEVA","customer":"FIRMENICH AROMATICS PRODUCTION INDIA PRIVATE LIM","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"9.4","totalValueFC":"940.9","currency":"USD","unitRateINR":"801.7","date":"14-May-2025","totalValueINR":"80165.43","totalValueInUsd":"940.9","indian_port":"Bombay Air","hs_no":"29181110","bill_no":"2042224","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"GENEVA","supplierAddress":"RUE DE LA BERGERE7 SATIGNY 1242- GE NEVA SDNF SWITZERLAND","customerAddress":"NOVELL HOUSE RD NO 13 MIDC MAROL"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747161000,"product":"LACTIC ACID 60% POWDER LACTIC ACID 60% POWDER","address":"7TH FLOOR, 713\/714, SHOP ZONE, M.G.ROAD,","city":"MUMBAI","supplier":"HENAN HONGHUI BIOTECHNOLOGY CO LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"TOTAL SOLUTIONS","customerCountry":"INDIA","quantity":"2250.00","actualQuantity":"2250","unit":"KGS","unitRateFc":"3","totalValueFC":"6777.7","currency":"USD","unitRateINR":"256.7","date":"14-May-2025","totalValueINR":"577462.5","totalValueInUsd":"6777.7","indian_port":"JNPT","hs_no":"29181110","bill_no":"2042603","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"9#, 2ND AREA, INDUSTRIAL PARK, HUAI YANG DISTRICT, ZHOUKOU CITY, HENAN PROVINCE, CHINA Zhoukou, , China China","customerAddress":"7TH FLOOR, 713\/714, SHOP ZONE, 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301, 3RD FL.","city":"MUMBAI MAHARASHTRA","supplier":"PURAC THAILAND LTD","supplierCountry":"THAILAND","foreign_port":"LAEM CHABANG","customer":"BRENNTAG INGREDIENTS INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"16000.00","actualQuantity":"16000","unit":"KGS","unitRateFc":"1.2","totalValueFC":"20119.3","currency":"USD","unitRateINR":"107.1","date":"23-May-2025","totalValueINR":"1714176","totalValueInUsd":"20119.3","indian_port":"JNPT","hs_no":"29181110","bill_no":"2235202","productDescription":"API","marketType":"","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"3 MOO 2, ASIA INDUSTRIAL ESTATE TAM BON BANCHANG, AMPHOE BANCHANG, RAYO NG 21130 Rayong, , Thailand Thailand","customerAddress":"ACKRUTI CENTRE POINT, 301, 3RD FL."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747938600,"product":"PURAC FCC 88 DRUM 25KG L(+)- LACTIC ACID FCC SPECIAL 88 PURAC FCC 88 DRUM 25KG L(+)- 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    06-Jan-2022
    27-May-2025
    KGS
    overview
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    Average Price (USD/KGS)

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    API Imports and Exports

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    (USD/KGS)    		 Number of Transactions

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;N/...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 21703

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    PharmaCompass offers a list of Lactic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lactic Acid manufacturer or Lactic Acid supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lactic Acid manufacturer or Lactic Acid supplier.

    PharmaCompass also assists you with knowing the Lactic Acid API Price utilized in the formulation of products. Lactic Acid API Price is not always fixed or binding as the Lactic Acid Price is obtained through a variety of data sources. The Lactic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Lactic Acid

    Synonyms

    2-hydroxypropanoic acid, Dl-lactic acid, 50-21-5, 2-hydroxypropionic acid, Milk acid, Lactate

    Cas Number

    50-21-5

    Unique Ingredient Identifier (UNII)

    3B8D35Y7S4

    About Lactic Acid

    A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed)

    Polylactic Acid Manufacturers

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

    Polylactic Acid Suppliers

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

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

    Polylactic Acid USDMF

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

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

    click here to find a list of Polylactic Acid suppliers with USDMF on PharmaCompass.

    Polylactic Acid JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Polylactic Acid Drug Master File in Japan (Polylactic Acid JDMF) empowers Polylactic Acid API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Polylactic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Polylactic Acid JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Polylactic Acid suppliers with JDMF on PharmaCompass.

    Polylactic Acid GMP

    Polylactic Acid 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 Polylactic Acid 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 Polylactic Acid GMP manufacturer or Polylactic Acid GMP API supplier for your needs.

    Polylactic Acid CoA

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

    Polylactic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Polylactic Acid 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.

    Polylactic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Polylactic Acid EP), Polylactic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Polylactic Acid 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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