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Chemistry

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Also known as: D-lactulose, Bifiteral, Cephulac, Chronulac, Constilac, Cholac
Molecular Formula
C12H22O11
Molecular Weight
342.30  g/mol
InChI Key
JCQLYHFGKNRPGE-FCVZTGTOSA-N
FDA UNII
9XH2P2N8EP

Lactulose
A synthetic disaccharide used in the treatment of constipation and hepatic encephalopathy. It has also been used in the diagnosis of gastrointestinal disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p887)
1 2D Structure

Lactulose

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,3R,4S,5R,6R)-2-[(2R,3S,4S,5R)-4,5-dihydroxy-2,5-bis(hydroxymethyl)oxolan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol
2.1.2 InChI
InChI=1S/C12H22O11/c13-1-4-6(16)7(17)8(18)11(21-4)22-9-5(2-14)23-12(20,3-15)10(9)19/h4-11,13-20H,1-3H2/t4-,5-,6+,7+,8-,9-,10+,11+,12-/m1/s1
2.1.3 InChI Key
JCQLYHFGKNRPGE-FCVZTGTOSA-N
2.1.4 Canonical SMILES
C(C1C(C(C(C(O1)OC2C(OC(C2O)(CO)O)CO)O)O)O)O
2.1.5 Isomeric SMILES
C([C@@H]1[C@@H]([C@@H]([C@H]([C@@H](O1)O[C@@H]2[C@H](O[C@@]([C@H]2O)(CO)O)CO)O)O)O)O
2.2 Other Identifiers
2.2.1 UNII
9XH2P2N8EP
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Amivalex

2. Duphalac

3. Normase

2.3.2 Depositor-Supplied Synonyms

1. D-lactulose

2. Bifiteral

3. Cephulac

4. Chronulac

5. Constilac

6. Cholac

7. Lactulosa

8. Lactulosum

9. Duphalac

10. 4618-18-2

11. 4-o-beta-d-galactopyranosyl-d-fructose

12. 9xh2p2n8ep

13. 4-o-beta-d-galactopyranosyl-d-fructofuranose

14. Chebi:6359

15. 58166-24-8

16. Isolactose

17. Laevolac

18. 4-o-beta-d-galactopyranosyl-beta-d-fructofuranose

19. Nsc-757082

20. (2s,3r,4s,5r,6r)-2-[(2r,3s,4s,5r)-4,5-dihydroxy-2,5-bis(hydroxymethyl)oxolan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol

21. Lactulosum [latin]

22. Lactulosa [spanish]

23. Kristalose

24. Lattulosio [italian]

25. Lactulosum [inn-latin]

26. Dsstox_cid_25833

27. Dsstox_rid_81161

28. Dsstox_gsid_45833

29. Lactulosa [inn-spanish]

30. 58166-25-9

31. Lattulosio

32. Actilax

33. Alpha-lactulose

34. Cephulac (tn)

35. (2s,3r,4s,5r,6r)-2-(((2r,3s,4s,5r)-4,5-dihydroxy-2,5-bis(hydroxymethyl)tetrahydrofuran-3-yl)oxy)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol

36. Cas-4618-18-2

37. Sr-05000002084

38. Einecs 225-027-7

39. Unii-9u7d5qh5ae

40. Unii-9xh2p2n8ep

41. Brn 0093773

42. Brn 6278818

43. 4-beta-d-galactosido-(1,4)-d-fructose

44. Delta-lactulose

45. D-fructose, 4-o-beta-d-galactopyranosyl-

46. Cephulac Syrup

47. Lactulose Syrup

48. 4-o-b-d-galactopyranosyl-d-fructose

49. Lactulose Jp17

50. Chronulac (tn)

51. Ncgc00094707-01

52. W9t

53. Beta-d-fructofuranose, 4-o-beta-d-galactopyranosyl-

54. Lactulose [usan:usp:inn:ban:jan]

55. 4-o-beta-d-galattopiranosil-d-fruttofuranosio [italian]

56. Spectrum_000857

57. Spectrum2_001159

58. Spectrum3_000478

59. Spectrum4_000962

60. Spectrum5_000908

61. .alpha.-lactulose

62. 4-o-beta-d-galattopiranosil-d-fruttofuranosio

63. Schembl18912

64. Bspbio_002216

65. Kbiogr_001303

66. Kbioss_001337

67. 5-17-07-00214 (beilstein Handbook Reference)

68. Fructofuranose, 4-o-beta-d-galactopyranosyl-, D-

69. Divk1c_000064

70. Spectrum1500363

71. Spbio_001117

72. Lactulose (jp17/usp/inn)

73. Alpha-d-fructofuranose, 4-o-beta-d-galactopyranosyl-

74. Chembl296306

75. Dtxsid5045833

76. Hms500d06

77. Kbio1_000064

78. Kbio2_001337

79. Kbio2_003905

80. Kbio2_006473

81. Kbio3_001436

82. Ninds_000064

83. Hms1920j03

84. Hms2094g15

85. Pharmakon1600-01500363

86. Zinc3977952

87. Tox21_111318

88. Bdbm50377984

89. Ccg-39552

90. Mfcd00151469

91. Nsc757082

92. Akos024283994

93. Tox21_111318_1

94. Db00581

95. Nsc 757082

96. Idi1_000064

97. Ncgc00142624-01

98. Ncgc00142624-02

99. Ncgc00142624-03

100. Ncgc00142624-05

101. 2-[(3s,4s,2r,5r)-2,5-bis(hydroxymethyl)-4,5-dihydroxyoxolan-3-yloxy](2s,4s,3r, 5r,6r)-6-(hydroxymethyl)-2h-3,4,5,6-tetrahydropyran-3,4,5-triol

102. 4-o-b-d-galactopyranosyl-d-fructofuranose

103. 4-o-beta-delta-galactopyranosyl-delta-fructose

104. C07064

105. D00352

106. Ab00052029_02

107. Q422689

108. 4-o-beta-delta-galactopyranosyl-delta-fructofuranose

109. Sr-05000002084-1

110. Sr-05000002084-4

111. .alpha.-d-fructofuranose, 4-o-.beta.-d-galactopyranosyl-

112. Wurcs=2.0/2,2,1/[ha122h-2b_2-5][a2112h-1b_1-5]/1-2/a4-b1

113. (2s,3r,4s,5r,6r)-2-{[(2r,3s,4s,5r)-4,5-dihydroxy-2,5-bis(hydroxymethyl)oxolan-3-yl]oxy}-6-(hydroxymethyl)oxane-3,4,5-triol

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 342.30 g/mol
Molecular Formula C12H22O11
XLogP3-4.3
Hydrogen Bond Donor Count8
Hydrogen Bond Acceptor Count11
Rotatable Bond Count5
Exact Mass342.11621151 g/mol
Monoisotopic Mass342.11621151 g/mol
Topological Polar Surface Area190 Ų
Heavy Atom Count23
Formal Charge0
Complexity395
Isotope Atom Count0
Defined Atom Stereocenter Count9
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 12  
Drug NameCholac
PubMed HealthLactulose (By mouth)
Drug ClassesGastrointestinal Agent, Laxative, Hyperosmotic
Drug LabelGenerlac Solution (Lactulose Solution, USP) is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of Generlac Solution contains: 10 g lactulose (and not more than 1.6 g galactose, not more than 1.2 g lactose, not...
Active IngredientLactulose
Dosage FormSolution
RouteOral, rectal
Strength10gm/15ml
Market StatusPrescription
CompanyAlra

2 of 12  
Drug NameConstilac
Active IngredientLactulose
Dosage FormSolution
RouteOral
Strength10gm/15ml
Market StatusPrescription
CompanyAlra

3 of 12  
Drug NameConstulose
PubMed HealthLactulose (By mouth)
Drug ClassesGastrointestinal Agent, Laxative, Hyperosmotic
Drug LabelLactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose).Lactulose is a colonic a...
Active IngredientLactulose
Dosage FormSolution
RouteOral
Strength10gm/15ml
Market StatusPrescription
CompanyActavis Mid Atlantic

4 of 12  
Drug NameEnulose
PubMed HealthLactulose (By mouth)
Drug ClassesGastrointestinal Agent, Laxative, Hyperosmotic
Drug LabelLactulose is a synthetic disaccharide in solution form for oral or rectal administration. Each15 mL of lactulose solution contains 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). Lactulose solut...
Active IngredientLactulose
Dosage FormSolution
RouteOral, rectal
Strength10gm/15ml
Market StatusPrescription
CompanyActavis Mid Atlantic

5 of 12  
Drug NameGenerlac
PubMed HealthLactulose (By mouth)
Drug ClassesGastrointestinal Agent, Laxative, Hyperosmotic
Drug LabelGenerlac Solution (Lactulose Solution, USP) is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of Generlac Solution contains: 10 g lactulose (and not more than 1.6 g galactose, not more than 1.2 g lactose, not...
Active IngredientLactulose
Dosage FormSolution
RouteOral, rectal
Strength10gm/15ml
Market StatusPrescription
CompanyMorton Grove Pharms

6 of 12  
Drug NameLactulose
Active IngredientLactulose
Dosage FormFor solution; Solution
RouteOral; Oral, rectal
Strength10gm/packet; 10gm/15ml; 20gm/packet
Market StatusPrescription
CompanyVintage Pharms; Ani Pharms; Fresenius Kabi; Pharm Assoc; Morton Grove; Roxane; Cumberland Pharms; Vistapharm; Hi Tech Pharma

7 of 12  
Drug NameCholac
PubMed HealthLactulose (By mouth)
Drug ClassesGastrointestinal Agent, Laxative, Hyperosmotic
Drug LabelGenerlac Solution (Lactulose Solution, USP) is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of Generlac Solution contains: 10 g lactulose (and not more than 1.6 g galactose, not more than 1.2 g lactose, not...
Active IngredientLactulose
Dosage FormSolution
RouteOral, rectal
Strength10gm/15ml
Market StatusPrescription
CompanyAlra

8 of 12  
Drug NameConstilac
Active IngredientLactulose
Dosage FormSolution
RouteOral
Strength10gm/15ml
Market StatusPrescription
CompanyAlra

9 of 12  
Drug NameConstulose
PubMed HealthLactulose (By mouth)
Drug ClassesGastrointestinal Agent, Laxative, Hyperosmotic
Drug LabelLactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose).Lactulose is a colonic a...
Active IngredientLactulose
Dosage FormSolution
RouteOral
Strength10gm/15ml
Market StatusPrescription
CompanyActavis Mid Atlantic

10 of 12  
Drug NameEnulose
PubMed HealthLactulose (By mouth)
Drug ClassesGastrointestinal Agent, Laxative, Hyperosmotic
Drug LabelLactulose is a synthetic disaccharide in solution form for oral or rectal administration. Each15 mL of lactulose solution contains 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). Lactulose solut...
Active IngredientLactulose
Dosage FormSolution
RouteOral, rectal
Strength10gm/15ml
Market StatusPrescription
CompanyActavis Mid Atlantic

11 of 12  
Drug NameGenerlac
PubMed HealthLactulose (By mouth)
Drug ClassesGastrointestinal Agent, Laxative, Hyperosmotic
Drug LabelGenerlac Solution (Lactulose Solution, USP) is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of Generlac Solution contains: 10 g lactulose (and not more than 1.6 g galactose, not more than 1.2 g lactose, not...
Active IngredientLactulose
Dosage FormSolution
RouteOral, rectal
Strength10gm/15ml
Market StatusPrescription
CompanyMorton Grove Pharms

12 of 12  
Drug NameLactulose
Active IngredientLactulose
Dosage FormFor solution; Solution
RouteOral; Oral, rectal
Strength10gm/packet; 10gm/15ml; 20gm/packet
Market StatusPrescription
CompanyVintage Pharms; Ani Pharms; Fresenius Kabi; Pharm Assoc; Morton Grove; Roxane; Cumberland Pharms; Vistapharm; Hi Tech Pharma

4.2 Drug Indication

Lactulose is indicated for use as a laxative in the treatment of chronic constipation in adults and geriatric patients. Additionally, lactulose is also employed as an adjunct to protein restriction and supportive therapy for the prevention and treatment of portal-systemic encephalopathy (PSE), including both the hepatic pre-coma and coma variations. In particular, lactulose solution has been effective at managing PSE resulting from surgical portacaval shunts or from chronic hepatic diseases like cirrhosis. Moreover, there have also been studies demonstrating the capacity for lactulose to minimize the formation of gallstones and even some investigations regarding the experimental use of the agent in developing novel anticancer agents owing to its ability to bind galactin carbohydrates involved in various tumor progressions.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Lactulose formulations are most commonly administered via the oral route or the rectal route. Consequently, because the substance experiences minimal absorption by the gut it typically remains localized in the gastrointestinal tract environment and ultimately demonstrates almost all of its pharmacologic effects within the gut. In particular, as lactulose elicits its laxative effects in enhancing stool amounts and softening stool, such biochemical and physiologic activities can cause increased bowel sounds (borborygmi), a feeling of bloatedness, belching, frequent flatus, and diarrhea.


5.2 MeSH Pharmacological Classification

Gastrointestinal Agents

Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion. (See all compounds classified as Gastrointestinal Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Pharmacological Classes
Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]; Acidifying Activity [MoA]
5.4 ATC Code

A06AD11

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


A - Alimentary tract and metabolism

A06 - Drugs for constipation

A06A - Drugs for constipation

A06AD - Osmotically acting laxatives

A06AD11 - Lactulose


5.5 Absorption, Distribution and Excretion

Absorption

After administration by the oral route, less than 3% of the given dose of lactulose solution is absorbed by the small intestine. The remaining unabsorbed lactulose reaches the large intestine where it is metabolized - but even then, negligible quantities of unchanged lactulose or its metabolites are absorbed across the colon.


Route of Elimination

The renal excretion of any lactulose that manages to be absorbed into the circulation has been determined to be 3% or less and is generally complete within 24 hours. Any unabsorbed lactulose is largely excreted with stool.


Volume of Distribution

Negligible amounts of lactulose - metabolized or non-metabolized - are absorbed into the body.. Most lactulose that is administered subsequently remains predominantly around the gastrointestinal tract area.


Clearance

Negligible amounts of lactulose - metabolized or non-metabolized - are absorbed into the body.. Regardless, data regarding the clearance of lactulose is not readily available or accessible.


5.6 Metabolism/Metabolites

Lactulose is essentially only metabolized in the colon by saccharolytic bacteria that are present there. In particular, the substance is broken down into lactic acid and small amounts of acetic and formic acid. Specific examples of bacteria that normally inhabit the large intestine that are capable of lactulose metabolism include Lactobacilli, Bacteroides, Escherichia coli, and Clostridia.


5.7 Biological Half-Life

The data regarding the half-life of lactulose is not readily available or accessible.


5.8 Mechanism of Action

Lactulose is a synthetic disaccharide derivative of lactose that consists of one molecule of galactose and one molecule of fructose. Saccharolytic bacteria present in the large intestine subsequently break the substance down into organic acids like lactic acid and small amounts of formic and acetic acids. Such resultant volatile fatty acid metabolites, in combination with hydrogen and methane that is also generated consequently enhance intraluminal gas formation, peristaltic gut motility, and elicit an osmotic effect that facilitates an increase in the water content of stool as well as associated stool softening. All of these actions ultimately assist in facilitating and increasing the frequency of bowel movements in patients experiencing constipation, although it may take 24 to 48 hours after using the medication for this laxative effect to become evident. At the same time, the formation of such acids via the metabolism of lactulose by colonic bacteria also acidifies the contents of the colon, thereby contributing to the treatment of portal-systemic encephalopathy (PSE). As one of the principal features of PSE involves the accumulation of nitrogenous waste products like ammonia in the systemic circulation, a state in which the colonic contents become more acidic than blood allows ammonia in the circulation to diffuse into the colon.. Furthermore, ammonia that diffuses into the acidic colon is ionized to ammonium ions that are incapable of being absorbed back into the blood. These effects, combined with the laxative action of lactulose facilitates the excretion of excess ammonia. And finally, it is also believed that an acidic colonic environment results in the elimination of urease-producing bacteria that contribute to the formation of ammonia while surviving colonic bacteria use up any trapped ammonia in the colon as a source of nitrogen for protein synthesis.


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02-Jan-2022
30-Apr-2025
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ABOUT THIS PAGE

Looking for 4618-18-2 / Lactulose API manufacturers, exporters & distributors?

Lactulose manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Lactulose 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 Lactulose manufacturer or Lactulose supplier for your needs.

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

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

API | Excipient name

Lactulose

Synonyms

D-lactulose, Bifiteral, Cephulac, Chronulac, Constilac, Cholac

Cas Number

4618-18-2

Unique Ingredient Identifier (UNII)

9XH2P2N8EP

About Lactulose

A synthetic disaccharide used in the treatment of constipation and hepatic encephalopathy. It has also been used in the diagnosis of gastrointestinal disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p887)

Kristalose Manufacturers

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

Kristalose Suppliers

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

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

Kristalose USDMF

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

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

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

Kristalose 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 Kristalose Drug Master File in Japan (Kristalose JDMF) empowers Kristalose 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 Kristalose JDMF during the approval evaluation for pharmaceutical products. At the time of Kristalose 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 Kristalose suppliers with JDMF on PharmaCompass.

Kristalose CEP

A Kristalose CEP of the European Pharmacopoeia monograph is often referred to as a Kristalose Certificate of Suitability (COS). The purpose of a Kristalose CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Kristalose EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Kristalose to their clients by showing that a Kristalose CEP has been issued for it. The manufacturer submits a Kristalose CEP (COS) as part of the market authorization procedure, and it takes on the role of a Kristalose CEP holder for the record. Additionally, the data presented in the Kristalose CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Kristalose DMF.

A Kristalose CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Kristalose 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 Kristalose suppliers with CEP (COS) on PharmaCompass.

Kristalose NDC

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 Kristalose as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Kristalose API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Kristalose 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Kristalose and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Kristalose NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Kristalose suppliers with NDC on PharmaCompass.

Kristalose GMP

Kristalose 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 Kristalose 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 Kristalose GMP manufacturer or Kristalose GMP API supplier for your needs.

Kristalose CoA

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

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

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