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Chemistry

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Also known as: Ondansetron hcl, 99614-01-4, Zofran, Ondemet, Emeset, Ondansetron (hydrochloride)
Molecular Formula
C18H20ClN3O
Molecular Weight
329.8  g/mol
InChI Key
MKBLHFILKIKSQM-UHFFFAOYSA-N
FDA UNII
2999F27MAD

Ondansetron Hydrochloride
A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.
1 2D Structure

Ondansetron Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1H-carbazol-4-one;hydrochloride
2.1.2 InChI
InChI=1S/C18H19N3O.ClH/c1-12-19-9-10-21(12)11-13-7-8-16-17(18(13)22)14-5-3-4-6-15(14)20(16)2;/h3-6,9-10,13H,7-8,11H2,1-2H3;1H
2.1.3 InChI Key
MKBLHFILKIKSQM-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=NC=CN1CC2CCC3=C(C2=O)C4=CC=CC=C4N3C.Cl
2.2 Other Identifiers
2.2.1 UNII
2999F27MAD
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4h-carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-

2. Dihydrate, Ondansetron Monohydrochloride

3. Gr 38032f

4. Gr-38032f

5. Gr38032f

6. Hydrochloride, Ondansetron

7. Monohydrochloride Dihydrate, Ondansetron

8. Monohydrochloride, Ondansetron

9. Odt, Zofran

10. Ondansetron

11. Ondansetron Monohydrochloride

12. Ondansetron Monohydrochloride Dihydrate

13. Ondansetron, (+,-)-isomer

14. Ondansetron, (r)-isomer

15. Ondansetron, (s)-isomer

16. Sn 307

17. Sn-307

18. Sn307

19. Zofran

20. Zofran Odt

2.3.2 Depositor-Supplied Synonyms

1. Ondansetron Hcl

2. 99614-01-4

3. Zofran

4. Ondemet

5. Emeset

6. Ondansetron (hydrochloride)

7. Zofran Odt

8. Nsc 665799

9. Ondansetronhydrochloride

10. 2999f27mad

11. Nsc-665799

12. C18h20cln3o

13. 4h-carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-, Monohydrochloride

14. Emetron

15. 1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-4h-carbazol-4-one Hydrochloride

16. 9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-1,2,3,9-tetrahydro-4h-carbazol-4-one Hydrochloride

17. 9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-2,3-dihydro-1h-carbazol-4(9h)-one Hydrochloride

18. Smr000469179

19. Gr 38032

20. Unii-2999f27mad

21. Sr-01000763250

22. Zofran Preservative Free

23. Zofran And Dextrose In Plastic Container

24. Cpd000469179

25. Ondansetron Hydrochloride Preservative Free

26. 9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-4h-carbazol-4-one Monohydrochloride

27. Schembl41455

28. Mls001304076

29. Mls001401397

30. Mls002222312

31. Regid_for_cid_68647

32. Gr 38032 Hcl

33. Ondansetron Hydrochloride, 98%

34. Chembl1201111

35. Ondansetron Hydrochloride- Bio-x

36. Ondansetron Hydrochloride And Dextrose In Plastic Container

37. Dtxsid701027913

38. Hms1571c18

39. Ondansetron Hydrochloride (zofran)

40. Hy-b0002

41. Ondansetron Hydrochloride And Sodium Chloride In Plastic Container

42. Mfcd00764297

43. Nsc665799

44. S1390

45. Ondansetron Hydrochloride [mi]

46. Akos015889292

47. Ab07046

48. Ccg-100852

49. Ccg-221058

50. Cs-1715

51. Gs-3597

52. H39o049

53. Nc00102

54. Ac-12464

55. Bo164177

56. Ondansetron Hydrochloride [who-dd]

57. Ondansetron Hydrochloride Anhydrous

58. O0407

59. Sw100810-5

60. Vu0424014-2

61. C90628

62. (+/-)-ondansetron Hydrochloride Anhydrous

63. A800774

64. Ondansetron Hydrochloride Anhydrous, (+/-)-

65. Q-201515

66. Sr-01000763250-5

67. Q27254405

68. 9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1h-carbazol-4-one;hydrochloride

69. 1,2,3,4-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-9h-carbazol-4-one Hydrochloride

70. 4h-carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-, Hydrochloride (1:1)

71. 9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-2,3,4,9-tetrahydro-1h-carbazol-4-one Hydrochloride

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 329.8 g/mol
Molecular Formula C18H20ClN3O
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count2
Rotatable Bond Count2
Exact Mass329.1294900 g/mol
Monoisotopic Mass329.1294900 g/mol
Topological Polar Surface Area39.8 Ų
Heavy Atom Count23
Formal Charge0
Complexity440
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 6  
Drug NameOndansetron hydrochloride
Drug LabelThe active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (1, 2, 3, 9-te...
Active IngredientOndansetron hydrochloride
Dosage FormTablet; Injectable; Solution
Routeoral; Injection; Oral
Strengtheq 4mg base; eq 2mg base/ml; eq 4mg base/5ml; eq 16mg; eq 16mg base; 16mg; eq 24mg base; eq 8mg base
Market StatusTentative Approval; Prescription
CompanyAmneal Pharms; Wockhardt; Silarx; Bedford; Hospira; Gland Pharma; Sun Pharm Inds (in); Teva; Apotex; Hikma Farmaceutica; Aurobindo Pharma; Natco Pharma; Taro; Sandoz; Par Pharm; Roxane; Glenmark Generics; Emcure Pharms; Fresenius Kabi Usa; Ipca Labs; Hikm

2 of 6  
Drug NameOndansetron hydrochloride preservative free
Active IngredientOndansetron hydrochloride
Dosage FormInjectable
RouteInjection
Strengtheq 2mg base/ml
Market StatusPrescription
CompanyWockhardt; Hospira; Teva; Hikma Farmaceutica; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Emcure Pharms; Fresenius Kabi Usa; Hikma Maple; Claris Lifesciences; Taro Pharms Ireland; Luitpold; Bedford Labs; Agila Speclts; Bd Rx

3 of 6  
Drug NameZofran preservative free
Active IngredientOndansetron hydrochloride
Dosage FormInjectable
RouteInjection
Strengtheq 2mg base/ml
Market StatusPrescription
CompanyGlaxosmithkline

4 of 6  
Drug NameOndansetron hydrochloride
Drug LabelThe active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (1, 2, 3, 9-te...
Active IngredientOndansetron hydrochloride
Dosage FormTablet; Injectable; Solution
Routeoral; Injection; Oral
Strengtheq 4mg base; eq 2mg base/ml; eq 4mg base/5ml; eq 16mg; eq 16mg base; 16mg; eq 24mg base; eq 8mg base
Market StatusTentative Approval; Prescription
CompanyAmneal Pharms; Wockhardt; Silarx; Bedford; Hospira; Gland Pharma; Sun Pharm Inds (in); Teva; Apotex; Hikma Farmaceutica; Aurobindo Pharma; Natco Pharma; Taro; Sandoz; Par Pharm; Roxane; Glenmark Generics; Emcure Pharms; Fresenius Kabi Usa; Ipca Labs; Hikm

5 of 6  
Drug NameOndansetron hydrochloride preservative free
Active IngredientOndansetron hydrochloride
Dosage FormInjectable
RouteInjection
Strengtheq 2mg base/ml
Market StatusPrescription
CompanyWockhardt; Hospira; Teva; Hikma Farmaceutica; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Emcure Pharms; Fresenius Kabi Usa; Hikma Maple; Claris Lifesciences; Taro Pharms Ireland; Luitpold; Bedford Labs; Agila Speclts; Bd Rx

6 of 6  
Drug NameZofran preservative free
Active IngredientOndansetron hydrochloride
Dosage FormInjectable
RouteInjection
Strengtheq 2mg base/ml
Market StatusPrescription
CompanyGlaxosmithkline

4.2 Drug Indication

Treatment of alcohol use disorder


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Serotonin 5-HT3 Receptor Antagonists

Drugs that bind to but do not activate SEROTONIN 5-HT3 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT3 RECEPTOR AGONISTS. (See all compounds classified as Serotonin 5-HT3 Receptor Antagonists.)


Antipruritics

Agents, usually topical, that relieve itching (pruritus). (See all compounds classified as Antipruritics.)


Antiemetics

Drugs used to prevent NAUSEA or VOMITING. (See all compounds classified as Antiemetics.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Serotonin-3 Receptor Antagonist [EPC]; Serotonin 3 Receptor Antagonists [MoA]

API Reference Price

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12-Jan-2022
30-Aug-2025
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CAS Number : 119812-29-2

End Use API : Ondansetron Hydrochloride

About The Company : Anugraha Chemicals, a company engaged in Contract Manufacturing and Manufacturing of APIs, Intermediates and Fine Chemicals, was established in 1991 and has a r...

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DOSAGE - INJECTABLE;INJECTION - EQ 2MG BASE/M...DOSAGE - INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20007

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DOSAGE - TABLET;ORAL - EQ 24MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20103

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DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20103

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DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20103

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DOSAGE - SOLUTION;ORAL - EQ 4MG BASE/5ML **Fe...DOSAGE - SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20605

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ABOUT THIS PAGE

Looking for 99614-01-4 / Ondansetron Hydrochloride API manufacturers, exporters & distributors?

Ondansetron Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ondansetron Hydrochloride

Synonyms

Ondansetron hcl, 99614-01-4, Zofran, Ondemet, Emeset, Ondansetron (hydrochloride)

Cas Number

99614-01-4

Unique Ingredient Identifier (UNII)

2999F27MAD

About Ondansetron Hydrochloride

A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.

Ondansetron Hydrochloride Manufacturers

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

Ondansetron Hydrochloride Suppliers

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

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

Ondansetron Hydrochloride USDMF

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

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

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

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

Ondansetron Hydrochloride KDMF

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

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

After submitting a Ondansetron Hydrochloride 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 Ondansetron Hydrochloride API can apply through the Korea Drug Master File (KDMF).

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

Ondansetron Hydrochloride CEP

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

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

Ondansetron Hydrochloride WC

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

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

Ondansetron Hydrochloride 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 Ondansetron Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ondansetron Hydrochloride 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 Ondansetron Hydrochloride 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 Ondansetron Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ondansetron Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

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

Ondansetron Hydrochloride GMP

Ondansetron Hydrochloride 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 Ondansetron Hydrochloride 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 Ondansetron Hydrochloride GMP manufacturer or Ondansetron Hydrochloride GMP API supplier for your needs.

Ondansetron Hydrochloride CoA

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

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

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