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1. 81025-04-9
2. D-lactitol Monohydrate
3. Lactitol (monohydrate)
4. Lactitol Hydrate
5. 4-o-beta-d-galactopyranosyl-d-glucitol Monohydrate
6. Uh2k6w1y64
7. (2s,3r,4r,5r)-4-[(2s,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexane-1,2,3,5,6-pentol;hydrate
8. Lactitol Hydrate (jan)
9. Lactitol Hydrate [jan]
10. D-glucitol, 4-o-beta-d-galactopyranosyl-, Hydrate (1:2)
11. Bli-400
12. Smr000499577
13. Nsc-759131
14. Pizensy
15. Unii-uh2k6w1y64
16. Portolac (tn)
17. (2s,3r,4r,5r)-4-(((2s,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2h-pyran-2-yl)oxy)hexane-1,2,3,5,6-pentaol Hydrate
18. Dsstox_cid_27028
19. Dsstox_rid_82049
20. Dsstox_gsid_47028
21. Mls001076675
22. Mls001361361
23. Mls002207095
24. Schembl230581
25. D-glucitol, 4-o-beta-d-galactopyranosyl-, Monohydrate
26. D-lactitol Monohydrate, ~99%
27. Chembl1200429
28. Dtxsid6047028
29. Lactitol Monohydrate [ii]
30. Lactitol Monohydrate [mi]
31. Hms2231o06
32. Hy-b1389
33. Tox21_302283
34. Mfcd00150767
35. S5282
36. Lactitol Monohydrate [who-dd]
37. Ccg-268187
38. Cs-4859
39. Nsc 759131
40. Ncgc00256064-01
41. As-57306
42. Lactitol Monohydrate [ep Monograph]
43. Cas-81025-04-9
44. D02039
45. D70309
46. A864616
47. Q27291076
48. Lactitol, United States Pharmacopeia (usp) Reference Standard
49. D-glucitol, 4-o-.beta.-d-galactopyranosyl-, Monohydrate
50. Lactitol Monohydrate, European Pharmacopoeia (ep) Reference Standard
51. (2s,3r,4r,5r)-4-((2s,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2h-pyran-2-yloxy)hexane-1,2,3,5,6-pentaol Hydrate
52. (2s,3r,4r,5r)-4-[(2s,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexane-1,2,3,5,6-pentol,hydrate
53. (2s,3r,4r,5r)-4-{[(2s,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}hexane-1,2,3,5,6-pentol Hydrate
| Molecular Weight | 362.33 g/mol |
|---|---|
| Molecular Formula | C12H26O12 |
| Hydrogen Bond Donor Count | 10 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 8 |
| Exact Mass | 362.14242626 g/mol |
| Monoisotopic Mass | 362.14242626 g/mol |
| Topological Polar Surface Area | 202 Ų |
| Heavy Atom Count | 24 |
| Formal Charge | 0 |
| Complexity | 343 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 9 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31871
Submission : 2017-09-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27765
Submission : 2013-11-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13952
Submission : 1998-12-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13970
Submission : 1998-12-04
Status : Inactive
Type : II
Certificate Number : R1-CEP 2011-255 - Rev 00
Issue Date : 2017-09-28
Type : Chemical
Substance Number : 1337
Status : Valid
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USDMF
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Certificate Number : R1-CEP 2011-255 - Rev 00
Status : Valid
Issue Date : 2017-09-28
Type : Chemical
Substance Number : 1337
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A Lactitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lactitol, including repackagers and relabelers. The FDA regulates Lactitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lactitol 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 Lactitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lactitol supplier is an individual or a company that provides Lactitol active pharmaceutical ingredient (API) or Lactitol finished formulations upon request. The Lactitol suppliers may include Lactitol API manufacturers, exporters, distributors and traders.
click here to find a list of Lactitol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lactitol DMF (Drug Master File) is a document detailing the whole manufacturing process of Lactitol active pharmaceutical ingredient (API) in detail. Different forms of Lactitol DMFs exist exist since differing nations have different regulations, such as Lactitol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lactitol DMF submitted to regulatory agencies in the US is known as a USDMF. Lactitol USDMF includes data on Lactitol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lactitol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lactitol suppliers with USDMF on PharmaCompass.
A Lactitol CEP of the European Pharmacopoeia monograph is often referred to as a Lactitol Certificate of Suitability (COS). The purpose of a Lactitol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lactitol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lactitol to their clients by showing that a Lactitol CEP has been issued for it. The manufacturer submits a Lactitol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lactitol CEP holder for the record. Additionally, the data presented in the Lactitol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lactitol DMF.
A Lactitol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lactitol 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 Lactitol suppliers with CEP (COS) on PharmaCompass.
Lactitol 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 Lactitol 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 Lactitol GMP manufacturer or Lactitol GMP API supplier for your needs.
A Lactitol CoA (Certificate of Analysis) is a formal document that attests to Lactitol's compliance with Lactitol specifications and serves as a tool for batch-level quality control.
Lactitol CoA mostly includes findings from lab analyses of a specific batch. For each Lactitol 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.
Lactitol may be tested according to a variety of international standards, such as European Pharmacopoeia (Lactitol EP), Lactitol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lactitol USP).
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