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Chemistry

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Also known as: 22457-89-2, Benphothiamine, Betivina, Benzoylthiamine monophosphate, S-benzoylthiamine o-monophosphate, S-benzoylthiamine monophosphate
Molecular Formula
C19H23N4O6PS
Molecular Weight
466.4  g/mol
InChI Key
BTNNPSLJPBRMLZ-LGMDPLHJSA-N

Benfotiamine
Benfotiamine has been investigated for the treatment and prevention of Diabetic Nephropathy and Diabetes Mellitus, Type 2.
1 2D Structure

Benfotiamine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
S-[(Z)-2-[(4-amino-2-methylpyrimidin-5-yl)methyl-formylamino]-5-phosphonooxypent-2-en-3-yl] benzenecarbothioate
2.1.2 InChI
InChI=1S/C19H23N4O6PS/c1-13(23(12-24)11-16-10-21-14(2)22-18(16)20)17(8-9-29-30(26,27)28)31-19(25)15-6-4-3-5-7-15/h3-7,10,12H,8-9,11H2,1-2H3,(H2,20,21,22)(H2,26,27,28)/b17-13-
2.1.3 InChI Key
BTNNPSLJPBRMLZ-LGMDPLHJSA-N
2.1.4 Canonical SMILES
CC1=NC=C(C(=N1)N)CN(C=O)C(=C(CCOP(=O)(O)O)SC(=O)C2=CC=CC=C2)C
2.1.5 Isomeric SMILES
CC1=NC=C(C(=N1)N)CN(C=O)/C(=C(/CCOP(=O)(O)O)\SC(=O)C2=CC=CC=C2)/C
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Benfothiamine

2. Benphothiamine

3. Btmp-benfo

4. Milgamma

5. Neurostop

6. S-benzoylthiamine Monophosphate

2.2.2 Depositor-Supplied Synonyms

1. 22457-89-2

2. Benphothiamine

3. Betivina

4. Benzoylthiamine Monophosphate

5. S-benzoylthiamine O-monophosphate

6. S-benzoylthiamine Monophosphate

7. Benfotiamina

8. Benfotiaminum

9. 22457-89-2 (free Acid)

10. S-[(z)-2-[(4-amino-2-methylpyrimidin-5-yl)methyl-formylamino]-5-phosphonooxypent-2-en-3-yl] Benzenecarbothioate

11. (z)-s-(2-(n-((4-amino-2-methylpyrimidin-5-yl)methyl)formamido)-5-(phosphonooxy)pent-2-en-3-yl) Benzothioate

12. S-[2-{[(4-amino-2-methylpyrimidin-5-yl)methyl](formyl)amino}-5-(phosphonooxy)pent-2-en-3-yl] Benzenecarbothioate

13. Sr-01000872627

14. N-((4-amino-2-methyl-5-pyrimidinyl)methyl)-n-(4-hydroxy-2-mercapto-1-methyl-1-butenyl)formamide S-benzoate O-phosphate

15. Chebi:41039

16. Prestwick_68

17. Biotamin (tn)

18. Mfcd00057343

19. Prestwick2_000654

20. Prestwick3_000654

21. Benfotiamine (jan/inn)

22. Bspbio_000687

23. Schembl188070

24. Bpbio1_000757

25. Chembl4303665

26. Schembl19184708

27. Hms1570c09

28. Hms2097c09

29. Hms3714c09

30. Zinc2015559

31. Stl453586

32. Akos015920320

33. Ac-8280

34. Ccg-220654

35. Db11748

36. Ncgc00179477-01

37. (3z)-4-{n-[(4-amino-2-methylpyrimidin-5-yl)methyl]carbonylamino}-3-(phenylcarb Onylthio)pent-3-enyl Dihydrogen Phosphate

38. 57b892

39. A15020

40. D01255

41. Sr-01000872627-1

42. Sr-01000872627-2

43. 137-74-6

44. S-[(2z)-2-{[(4-amino-2-methylpyrimidin-5-yl)methyl](formyl)amino}-5-(phosphonooxy)pent-2-en-3-yl] Benzenecarbothioate

45. S-{(1z)-2-[[(4-amino-2-methyl-5-pyrimidinyl)methyl](formyl)amino]-1-[2-(phosphonooxy)ethyl]-1-propenyl} Benzenecarbothioate

46. S-{(1z)-2-[[(4-amino-2-methyl-5-pyrimidinyl)methyl](formyl)amino]-1-[2-(phosphonooxy)ethyl]-1-propenyl} Benzenecarbothioate, Aldrichcpr

2.3 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 466.4 g/mol
Molecular Formula C19H23N4O6PS
XLogP30.5
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count10
Rotatable Bond Count10
Exact Mass466.10759264 g/mol
Monoisotopic Mass466.10759264 g/mol
Topological Polar Surface Area181 Ų
Heavy Atom Count31
Formal Charge0
Complexity697
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Adjuvants, Immunologic

Substances that augment, stimulate, activate, potentiate, or modulate the immune response at either the cellular or humoral level. The classical agents (Freund's adjuvant, BCG, Corynebacterium parvum, et al.) contain bacterial antigens. Some are endogenous (e.g., histamine, interferon, transfer factor, tuftsin, interleukin-1). Their mode of action is either non-specific, resulting in increased immune responsiveness to a wide variety of antigens, or antigen-specific, i.e., affecting a restricted type of immune response to a narrow group of antigens. The therapeutic efficacy of many biological response modifiers is related to their antigen-specific immunoadjuvanticity. (See all compounds classified as Adjuvants, Immunologic.)


Chelating Agents

Chemicals that bind to and remove ions from solutions. Many chelating agents function through the formation of COORDINATION COMPLEXES with METALS. (See all compounds classified as Chelating Agents.)


4.2 ATC Code

A - Alimentary tract and metabolism

A11 - Vitamins

A11D - Vitamin b1, plain and in combination with vitamin b6 and b12

A11DA - Vitamin b1, plain

A11DA03 - Benfotiamine


USDMF

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38067

Submission : 2023-02-20

Status : Active

Type : II

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Benfotiamine (for manufacturing purposes only)

Registration Number : 217MF11200

Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture

Initial Date of Registration : 2005-12-12

Latest Date of Registration : 2007-05-15

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Benfotiamine "Yonezawa"

Registration Number : 217MF10852

Registrant's Address : 1-19-40 Nanko Kita, Suminoe-ku, Osaka City, Osaka Prefecture

Initial Date of Registration : 2005-11-01

Latest Date of Registration : 2007-04-27

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Benfotiamine

Registrant Name : Daeshin Pharmaceutical Co., Ltd.

Registration Date : 2022-01-12

Registration Number : 20210323-211-J-662(4)

Manufacturer Name : Ami Lifesciences Private Lim...

Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...

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Benfotiamine

Registrant Name : Agerson Bio Co., Ltd.

Registration Date : 2025-02-05

Registration Number : 20210323-211-J-662(9)

Manufacturer Name : Ami Lifesciences Private Lim...

Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...

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Benfotiamine

Registrant Name : Farm East Co., Ltd.

Registration Date : 2023-10-06

Registration Number : 20210323-211-J-662(8)

Manufacturer Name : Ami Lifesciences Private Lim...

Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...

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Benfotiamine

Registrant Name : Kyungbo Pharmaceutical Co., Ltd.

Registration Date : 2021-09-09

Registration Number : 20210323-211-J-662(3)

Manufacturer Name : Ami Lifesciences Private Lim...

Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...

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Benfotiamine

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2021-09-07

Registration Number : 20210323-211-J-662(2)

Manufacturer Name : Ami Lifesciences Private Lim...

Manufacturer Address : Block No.82/B, ECP Road, At & Post, Karakhadi, TAL-Pradra City : Karakhadi-391 450, D...

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Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2021-03-23

Registration Number : 20210323-211-J-662

Manufacturer Name : Ami Lifesciences Private Lim...

Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...

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Registrant Name : Hwain Farm Co., Ltd.

Registration Date : 2022-05-12

Registration Number : 20210323-211-J-662(5)

Manufacturer Name : Ami Lifesciences Private Lim...

Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...

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Benfotiamine

Registrant Name : IMCD Korea Co., Ltd.

Registration Date : 2021-08-30

Registration Number : 20210323-211-J-662(1)

Manufacturer Name : Ami Lifesciences Private Lim...

Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...

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Benfotiamine

Registrant Name : Hiple Co., Ltd.

Registration Date : 2023-09-12

Registration Number : 20210323-211-J-662(7)

Manufacturer Name : Ami Lifesciences Private Lim...

Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...

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Benfotiamine

Registrant Name : Huseeed Co., Ltd.

Registration Date : 2022-07-26

Registration Number : 20210323-211-J-662(6)

Manufacturer Name : Ami Lifesciences Private Lim...

Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...

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About the Company : Panvo Organics Pvt. Ltd. is a WHO-GMP certified manufacturer of Active Pharmaceutical Ingredients, Novel Formulations, and Sustainable Agriculture Inputs. Our Halal- and Kosher-cer...

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About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...

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About the Company : Chynops Pharma is an ISO 9001:2015 certified company based in Ahmedabad, India. We specializes in exporting, supplying, and trading a wide range of products, including APIs, advanc...

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About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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About the Company : Kinsy is an independent CDMO in Spain with over 30 years of experience in developing and manufacturing pharmaceutical intermediates and APIs. The company provides route development...

Kinsy is an independent CDMO in Spain with over 30 years of experience in developing and manufacturing pharmaceutical intermediates and APIs. The company provides route development, analytical optimization, pilot plant scale-up, and clinical-phase production using advanced purification techniques. Services include process validation, commercial-scale manufacturing (>100 MT/year), and regulatory support such as DMF, CEP, and REACH. Kinsy is ISO 9001-certified and operates under cGMP standards audited by AEMPS. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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About the Company : Zeal Medipharma is a Star-rated Export House serving customers in over 50 countries for more than two decades. The company specializes in sourcing and exporting APIs for human and ...

Zeal Medipharma is a Star-rated Export House serving customers in over 50 countries for more than two decades. The company specializes in sourcing and exporting APIs for human and veterinary use, along with drug intermediates, excipients, and semi-finished forms such as pellets and DC granules. Its portfolio also includes herbal extracts, phytochemicals, nutraceuticals, food and feed ingredients, agrochemicals, preservatives, surfactants, and specialty chemicals, supporting global healthcare and industrial markets. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with 26+ years in human and veterinary pharmaceuticals. Operating in 40+ countries, it owns two Gujarat facilities...

Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with 26+ years in human and veterinary pharmaceuticals. Operating in 40+ countries, it owns two Gujarat facilities and partners with 16+ plants. Holding USFDA, EU-GMP, WHO-GMP, and other certifications, it is the largest exporter for 12 molecules worldwide. With robust regulatory compliance (DMF, CEP, ICH Q7), Shamrock is the preferred API partner in India. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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About the Company : Enaltec, founded in 2006, specializes in developing and manufacturing complex, small-volume, technology-driven APIs at competitive prices, leveraging the India advantage for global...

Enaltec, founded in 2006, specializes in developing and manufacturing complex, small-volume, technology-driven APIs at competitive prices, leveraging the India advantage for global generic formulators. The company operates USFDA-approved and WHO-GMP-approved facilities, a DSIR-approved R&D center, GLP-compliant labs, and cGMP-certified plants. Enaltec has developed over 90 products for regulated and semi-regulated markets in just 16 years, driving advanced synthesis and analytical research. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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16-Feb-2022
14-Nov-2025
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ABOUT THIS PAGE

Looking for 22457-89-2 / Benfotiamine API manufacturers, exporters & distributors?

Benfotiamine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Benfotiamine

Synonyms

22457-89-2, Benphothiamine, Betivina, Benzoylthiamine monophosphate, S-benzoylthiamine o-monophosphate, S-benzoylthiamine monophosphate

Cas Number

22457-89-2

About Benfotiamine

Benfotiamine has been investigated for the treatment and prevention of Diabetic Nephropathy and Diabetes Mellitus, Type 2.

Benfotiamine Manufacturers

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

Benfotiamine Suppliers

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

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

Benfotiamine USDMF

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

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

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

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

Benfotiamine KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Benfotiamine Drug Master File in Korea (Benfotiamine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Benfotiamine. The MFDS reviews the Benfotiamine KDMF as part of the drug registration process and uses the information provided in the Benfotiamine KDMF to evaluate the safety and efficacy of the drug.

After submitting a Benfotiamine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Benfotiamine API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Benfotiamine suppliers with KDMF on PharmaCompass.

Benfotiamine WC

A Benfotiamine written confirmation (Benfotiamine WC) is an official document issued by a regulatory agency to a Benfotiamine manufacturer, verifying that the manufacturing facility of a Benfotiamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Benfotiamine APIs or Benfotiamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Benfotiamine WC (written confirmation) as part of the regulatory process.

click here to find a list of Benfotiamine suppliers with Written Confirmation (WC) on PharmaCompass.

Benfotiamine GMP

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

Benfotiamine CoA

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

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

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