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ACTIVE PHARMA INGREDIENTS

14 API Suppliers, 2 USDMF, 12 Listed Suppliers, $ API Reference Price

14 API Suppliers
2 USDMF
12 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

10 FDF Dossiers, 1 Europe, 9 Listed Dossiers

10 FDF Dossiers
1 Europe
9 Listed Dossiers

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 8 DKSH, 3 Faran Shimi Pharmaceutical, 10 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 11 Corel Pharma Chem, 3 DFE Pharma, 1 Finar, 11 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 17 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 18 Roquette, 13 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

53 Coating Systems & Additives, 47 Fillers, Diluents & Binders, 30 Controlled & Modified Release, 26 Thickeners and Stabilizers, 24 Direct Compression, 20 Disintegrants & Superdisintegrants, 17 Solubilizers, 16 Lubricants & Glidants, 15 Parenteral, 15 Film Formers & Plasticizers, 14 Granulation, 14 Topical, 12 Co-Processed Excipients, 10 Taste Masking, 9 Empty Capsules, 8 Emulsifying Agents, 6 API Stability Enhancers, 6 Chewable & Orodispersible Aids, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

2 NEWS #PharmaBuzz

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2 NEWS #PharmaBuzz

MARKET PLACE

6 APIs

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6 APIs

REF. STANDARDS & IMPURITIES

1 USP , 3 Others

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1 USP
3 Others

ANALYTICAL

1 Analytical Methods

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1 Analytical Methods

Lutein

Synopsis

ACTIVE PHARMA INGREDIENTS

14

API Suppliers

2

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

0

EU WC

0

KDMF

0

NDC API

0

VMF

12

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 80

MARKET PLACE

6

API

0

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

10

FDF Dossiers

0

FDA Orange Book

FDA (Orange Book)

1

Europe

0

Canada

0

Australia

0

South Africa

9

Listed Dossiers

2DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

1

USP

0

JP

3

Others

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Health Canada Patents

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207 RELATED EXCIPIENT COMPANIES

357EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Xanthophyll, 127-40-2, Bo-xan, Vegetable lutein, Vegetable luteol, All-trans-lutein

Molecular Formula

C₄₀H₅₆O₂

Molecular Weight

568.9 g/mol

InChI Key

KBPHJBAIARWVSC-RGZFRNHPSA-N

FDA UNII

X72A60C9MT

Lutein

A xanthophyll found in the major LIGHT-HARVESTING PROTEIN COMPLEXES of plants. Dietary lutein accumulates in the MACULA LUTEA.

1 2D Structure

Lutein

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(1R)-4-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-[(1R,4R)-4-hydroxy-2,6,6-trimethylcyclohex-2-en-1-yl]-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaenyl]-3,5,5-trimethylcyclohex-3-en-1-ol

2.1.2 InChI

InChI=1S/C40H56O2/c1-29(17-13-19-31(3)21-23-37-33(5)25-35(41)27-39(37,7)8)15-11-12-16-30(2)18-14-20-32(4)22-24-38-34(6)26-36(42)28-40(38,9)10/h11-25,35-37,41-42H,26-28H2,1-10H3/b12-11+,17-13+,18-14+,23-21+,24-22+,29-15+,30-16+,31-19+,32-20+/t35-,36+,37-/m0/s1

2.1.3 InChI Key

KBPHJBAIARWVSC-RGZFRNHPSA-N

2.1.4 Canonical SMILES

CC1=C(C(CC(C1)O)(C)C)C=CC(=CC=CC(=CC=CC=C(C)C=CC=C(C)C=CC2C(=CC(CC2(C)C)O)C)C)C

2.1.5 Isomeric SMILES

CC1=C(C(C[C@@H](C1)O)(C)C)/C=C/C(=C/C=C/C(=C/C=C/C=C(\C)/C=C/C=C(\C)/C=C/[C@H]2C(=C[C@@H](CC2(C)C)O)C)/C)/C

2.2 Other Identifiers

2.2.1 UNII

X72A60C9MT

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Beta,epsilon-carotene-3, 3'-diol, (3r,3'r,6's)-

2. Beta,epsilon-carotene-3,3'-diol, (3s,3'r,6's)-

3. Gamma Lutein

4. Lutein F

5. Lutein G

6. Lutein, Gamma

2.3.2 Depositor-Supplied Synonyms

1. Xanthophyll

2. 127-40-2

3. Bo-xan

4. Vegetable Lutein

5. Vegetable Luteol

6. All-trans-lutein

7. Xantofyl

8. Lutein Ester

9. Lutein A

10. All-trans-(+)-xanthophyll

11. Floraglo

12. Floraglo Lutein

13. Trans-lutein

14. Lutein, All-trans-

15. All-trans-xanthophyll

16. Oro Glo 7

17. E 161b

18. Beta,epsilon-carotene-3,3'-diol, (3r,3'r,6'r)-

19. Xanthophyll, All-trans-(+)-

20. (3r,3'r,6'r)-lutein

21. Beta,epsilon-carotene-3,3'-diol

22. Os 24

23. Lutein From Tagetes Erecta

24. Ins No.161b(i)

25. X72a60c9mt

26. E 161

27. Chebi:28838

28. Ins-161b(i)

29. E-161b

30. E-161b(i)

31. Nsc-59193

32. .beta.,.epsilon.-carotene-3,3'-diol

33. .beta.,.epsilon.-carotene-3,3'-diol, (3r,3'r,6'r)-

34. (1r)-4-[(1e,3e,5e,7e,9e,11e,13e,15e,17e)-18-[(1r,4r)-4-hydroxy-2,6,6-trimethylcyclohex-2-en-1-yl]-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaenyl]-3,5,5-trimethylcyclohex-3-en-1-ol

35. (1r,4r)-4-((1e,3e,5e,7e,9e,11e,13e,15e,17e)-18-((r)-4-hydroxy-2,6,6-trimethylcyclohex-1-en-1-yl)-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaen-1-yl)-3,5,5-trimethylcyclohex-2-enol

36. (3r,3'r,6'r)-beta,epsilon-carotene-3,3'-diol

37. 180580-60-3

38. 9-cis-lutein

39. Lutamax

40. 13-cis-lutein

41. Unii-x72a60c9mt

42. Leutein

43. Ncgc00167965-01

44. 15-cis-lutein

45. Einecs 204-840-0

46. 13'-cis-lutein

47. Nsc 59193

48. Lutein (xanthophyll)

49. (9'z)-lutein

50. Lutein - 5%

51. Leutein [vandf]

52. Xanthophyll (~80%)

53. Lutein [vandf]

54. E-carotene-3,3'-diol

55. Lutein - 10%

56. Lutein - 20%

57. Lutein [dsc]

58. Lutein [fcc]

59. Xanthophyll [mi]

60. Lutein [usp-rs]

61. Lutein [mart.]

62. Xanthophyll, From Marigold

63. Xantofyl [who-dd]

64. Lutein, Analytical Standard

65. Dsstox_cid_26749

66. Dsstox_rid_81874

67. Dsstox_gsid_46749

68. Schembl19342

69. 3,3'-dihydroxy-alpha-carotene

70. Chembl173929

71. Dtxsid8046749

72. (invertedexclamationmarka)-lutein

73. Bcbcmap01_000190

74. Hms3886i13

75. 29414-89-9

76. Hy-n6947

77. Zinc8221225

78. (3r,3'r)-dihydroxy-alpha-carotene

79. Tox21_112594

80. ( Inverted Exclamation Marka)-lutein

81. Bbl101804

82. Lmpr01070274

83. Mfcd00017353

84. S5103

85. Stl555601

86. Akos008901394

87. Ccg-270087

88. Db00137

89. Smp1_000317

90. As-63011

91. Cas-127-40-2

92. Xl176941

93. Xl176947

94. Xl176948

95. Cs-0015250

96. C08601

97. Q63409232

98. Lutein Solution, 1 Mg/l In Ethanol, Analytical Standard

99. 4',5'-didehydro-6'-hydro-.beta.-carotene-3,3'-diol #

100. Ab972dac-e626-49f1-898d-598af7729fd0

101. (3r,3'r,6r)-4,5-didehydro-5,6-dihydro-beta,beta-carotene-3,3'-diol

102. Lutein, Pharmaceutical Secondary Standard; Certified Reference Material

103. (3r,3'r,6r)-4,5-didehydro-5,6-dihydro-.beta.,.beta.-carotene-3,3'-diol

104. (3r,3'r,6r)-4,5-didehydro-5,6-dihydro-.beta.,.beta.-carotin-3,3'-diol

105. .beta.,.beta.-carotene-3,3'-diol, 4,5-didehydro-5,6-dihydro-, (3r,3'r,6r)-

106. (1r)-4-[(1e,3e,5e,7e,9e,11e,13e,15e,17e)-18-[(1r,4r)-4-hydroxy-2,6,6-trimethyl-cyclohex-2-en-1-yl]-3,7,12,16-tetramethyl-octadeca-1,3,5,7,9,11,13,15,17-nonaenyl]-3,5,5-trimethyl-cyclohex-3-en-1-ol

107. (1r,4r)-4-((1e,3e,5e,7e,9e,11e,13e,15e,17e)-18-((4r)-4-hydroxy-2,6,6-trimethyl-1-cyclohexen-1-yl)-3,7,12,16-tetramethyl-1,3,5,7,9,11,13,15,17-octadecanonaen-1-yl)-3,5,5-trimethyl-2-cyclohexen-1-ol

2.4 Create Date

2004-09-16

3 Chemical and Physical Properties

Molecular Formula	C₄₀H₅₆O₂
Molecular Weight	568.9 g/mol
XLogP3	11
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	10
Exact Mass	568.42803102 g/mol
Monoisotopic Mass	568.42803102 g/mol
Topological Polar Surface Area	40.5 Å²
Heavy Atom Count	42
Formal Charge	0
Complexity	1270
Isotope Atom Count	0
Defined Atom Stereocenter Count	3
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	9
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Indication

Xanthophylls are taken for nutritional supplementation, and also for treating dietary shortage or imbalance.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Lutein was found to be present in a concentrated area of the macula, a small area of the retina responsible for central vision. The hypothesis for the natural concentration is that lutein helps protect from oxidative stress and high-energy light. Several studies show that an increase in macula pigmentation decreases the risk for eye diseases such as Age-related Macular Degeneration (AMD).

5.2 Mechanism of Action

Xanthophylls have antioxidant activity and react with active oxygen species, producing biologically active degradation products. They also can inhibit peroxidation of membrane phospholipids and reduce lipofuscin formation, both of which contribute to their antioxidant properties. Lutein is naturally present in the macula of the human retina. It filters out potentially phototoxic blue light and near-ultraviolet radiation from the macula. The protective effect is due in part, to the reactive oxygen species quenching ability of these carotenoids. Lutein is more stable to decomposition by pro-oxidants than are other carotenoids such as beta-carotene and lycopene. Lutein is abundant in the region surrounding the fovea, and lutein is the predominant pigment at the outermost periphery of the macula. Zeaxanthin, which is fully conjugated (lutein is not), may offer somewhat better protection than lutein against phototoxic damage caused by blue and near-ultraviolet light radiation. Lutein is one of only two carotenoids that have been identified in the human lens, may be protective against age-related increases in lens density and cataract formation. Again, the possible protection afforded by lutein may be accounted for, in part, by its reactive oxygen species scavenging abilities. Carotenoids also provide protection from cancer. One of the mechanisms of this is by increasing the expression of the protein connexin-43, thereby stimulating gap junctional communication and preventing unrestrained cell proliferation.

API SUPPLIERS

01

Basic Nutrition

China

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Sunpure Extracts

India

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03

ALP Pharm

China

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04

Bio-gen Extracts

India

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Bio-gen Extracts

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Bio-gen Extracts

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Bio-gen Extracts

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Hunan Bitian Technology

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Summit Ingredients

China

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Sunriver Biotech

China

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Alp Pharm Beijing Co Ltd

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Sunpure Extracts Pvt Ltd

India

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Basic Nutrition

China

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About the Company : As an ISO9001, ISO22000 certificated supplier, Basic Nutrition supply high-quality ingredients for nutraceuticals. We can offer a range of products from small to large quantites: h...

As an ISO9001, ISO22000 certificated supplier, Basic Nutrition supply high-quality ingredients for nutraceuticals. We can offer a range of products from small to large quantites: herbal extract, amino acid, vitamin, etc. Featured products: cranberry extract, rhidiola extract, Q10, hyaluronic acid, cysteine (non-animals), glutathoninr, orgaic products like organic spirulina, organic red yeast rice powder, etc.

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

01

Bausch & Lomb Incorporated

Canada

PharmaVenue

Not Confirmed

02

BioAdaptives

U.S.A

PharmaVenue

Not Confirmed

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Europe

01

Farmak JSC

Ukraine

Duphat

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APIs

Lutein (200 g - 500 g) API needed in India [ENA20973]

A company that provides formulation development & analytical services for human & veterinary use is looking for suppliers of Lutein (200 g - 500 g) API for development purposes. The suppliers must support this enquiry with CoA.

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28 Oct 2024

Various APIs needed in Bangladesh [ENA13520]

A company that deals in various pharmaceutical products is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. Biotin API 2. Cyanocobalamin API 3. Cholecalciferol API 4. Folic Acid API 5. Lutein API 6. Mecobalamin API 7. Niacin API 8. Pyridoxine Hydrochloride API 9. Riboflavin API 10. Thiamine Hydrochloride API 11. Thiamine Mononitrate API

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04 May 2022

Various APIs needed in Russia [ENA13271]

A company that specializes in marketing & distribution of various pharmaceutical products is looking for suppliers of Various APIs for dietary supplement. 1. Zinc Citrate (28 kg) API 2. Lutein (4 kg) API 3. Zeaxanthin (0.5 kg) API 4. Ginkgo Biloba Extract (35 kg) API 5. Dihydroquercetin (14 kg) API

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11 Apr 2022

Pharma Grade Lutein API needed in Croatia [ENA10826]

A company that aimed at developing and manufacturing drugs in target therapeutic areas, with a focus on the senses is looking for suppliers of Pure, Synthetic, Pharma Grade Lutein API for Ophthalmic formulation. The final market is Russia, CIS & Europe.

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09 Jul 2021

Various APIs needed in Iran [ENA09361]

A pharmaceutical company that specializes in different medicines and pharmaceutical supplements is looking for suppliers of Various APIs for commercial purposes. The required quantity is 1 MT for each. The suppliers must support this enquiry with CoA. 1. USP/BP Grade Lutein API 2. USP/BP Grade Zeaxanthin API 3. USP/BP Grade L-Lysine Hydrochloride API 4. USP/BP Grade Taurine API 5. USP/BP Grade L-Carnitine API

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28 Dec 2020

Various APIs needed in India [ENA09007]

Sheri Trading Company, a leading Suppliers & Importers of chemicals & rubber products is looking for suppliers of Various APIs. The required quantity is 100 kg for each. Interested suppliers can contact them via their email: nitin@sheritrading.com. 1. L-Arginine API 2. L-Glutamine API 3. Calcium ? hydroxy ? methyl butyrate API 4. Lutein API 5. Zeaxanthin API 6. Retinol API 7. Tocopherol API 8. Ascorbic Acid API 9. Ergocalciferol API 10. Biotin API 11. Hydrolyzed Collagen Peptide API 12. Sodium Hyaluronate API 13. Trans-Resveratrol API

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07 Nov 2020

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ABOUT THIS PAGE

Lutein Manufacturers

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

Lutein Suppliers

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

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

Lutein USDMF

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

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

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

Lutein GMP

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

Lutein CoA

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

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

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