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    Chemistry

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    Also known as: 4682-36-4, Norflex, Banflex, Orphenadrine dihydrogen citrate, Flexon, Orphenadrine (citrate)
    Molecular Formula
    C24H31NO8
    Molecular Weight
    461.5  g/mol
    InChI Key
    MMMNTDFSPSQXJP-UHFFFAOYSA-N
    FDA UNII
    X0A40N8I4S
    Orphenadrine
    A muscarinic antagonist used to treat drug-induced parkinsonism and to relieve pain from muscle spasm.
    1 2D Structure

    Orphenadrine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N,N-dimethyl-2-[(2-methylphenyl)-phenylmethoxy]ethanamine;2-hydroxypropane-1,2,3-tricarboxylic acid
    2.1.2 InChI
    InChI=1S/C18H23NO.C6H8O7/c1-15-9-7-8-12-17(15)18(20-14-13-19(2)3)16-10-5-4-6-11-16;7-3(8)1-6(13,5(11)12)2-4(9)10/h4-12,18H,13-14H2,1-3H3;13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)
    2.1.3 InChI Key
    MMMNTDFSPSQXJP-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=CC=CC=C1C(C2=CC=CC=C2)OCCN(C)C.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    X0A40N8I4S
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Citrate, Norflex Orphenadrine

    2. Citrate, Orphenadrine

    3. Disipal

    4. Hydrochloride, Orphenadrine

    5. Lysantin

    6. Mefenamine

    7. Mefenamine, Sodium

    8. Mephenamine

    9. Methyldiphenylhydramine

    10. Norflex

    11. Norflex Orphenadrine Citrate

    12. Orphenadrine

    13. Orphenadrine Citrate, Norflex

    14. Orphenadrine Hydrochloride

    15. Sodium Mefenamine

    2.3.2 Depositor-Supplied Synonyms

    1. 4682-36-4

    2. Norflex

    3. Banflex

    4. Orphenadrine Dihydrogen Citrate

    5. Flexon

    6. Orphenadrine (citrate)

    7. Flexoject

    8. X-otag

    9. Orphenadrine Citrate Salt

    10. 2-hydroxypropane-1,2,3-tricarboxylic Acid; Dimethyl({2-[(2-methylphenyl)(phenyl)methoxy]ethyl})amine

    11. 4596-23-0

    12. Nsc-757238

    13. Orphenadrine Citrate [usp]

    14. N,n-dimethyl-2-[(2-methylphenyl)-phenylmethoxy]ethanamine;2-hydroxypropane-1,2,3-tricarboxylic Acid

    15. Orphenadrine Citrate (norflex)

    16. Chebi:7790

    17. X0a40n8i4s

    18. N,n-dimethyl-2-(phenyl(o-tolyl)methoxy)ethanamine 2-hydroxypropane-1,2,3-tricarboxylate

    19. Ncgc00094745-01

    20. Plenactol

    21. Euflex

    22. Flexor

    23. Tega-flex

    24. Orphenadrine Citrate (usp)

    25. Dsstox_cid_24678

    26. Dsstox_rid_80390

    27. Dsstox_gsid_44678

    28. Norflex (pharmaceutical)

    29. Orphenadrinecitrate

    30. N,n-dimethyl-2-(phenyl(o-tolyl)methoxy)ethan-1-amine 2-hydroxypropane-1,2,3-tricarboxylate

    31. Cas-4682-36-4

    32. Einecs 225-137-5

    33. Unii-x0a40n8i4s

    34. Norflex (tn)

    35. Orphenadine Citrate

    36. N,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate (1:1)

    37. Ethanamine, N,n-dimethyl-2-((2-methylphenyl)phenylmethoxy)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

    38. Mls000069549

    39. Schembl119470

    40. Spectrum1500447

    41. Chembl1200395

    42. Dtxsid8044678

    43. Hms502k15

    44. Hy-b0369a

    45. Orphenadrine Citrate [mi]

    46. Hms1920d10

    47. Hms2091l10

    48. Hms2231j06

    49. Hms3259m21

    50. Hms3370m12

    51. Hms3651a10

    52. Hms3884m22

    53. Pharmakon1600-01500447

    54. Citric Acid; N,n-dimethyl-2-[o-tolyl(phenyl)methoxy]ethanamine

    55. O-methyldiphenhydramine Citrate Salt

    56. Orphenadrine Citrate [vandf]

    57. Tox21_111323

    58. Tox21_113543

    59. Tox21_301079

    60. Ccg-40242

    61. Nsc757238

    62. Orphenadrine Citrate [mart.]

    63. Orphenadrine Citrate [who-dd]

    64. Akos008132385

    65. Tox21_111323_1

    66. Nc00525

    67. Nsc 757238

    68. (+-)-n,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate (1:1)

    69. Ethylamine, N,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)-, Citrate (1:1)

    70. Ncgc00015771-13

    71. Ncgc00094745-02

    72. Ncgc00094745-03

    73. Ncgc00254980-01

    74. As-74807

    75. Ethanamine, N,n-dimethyl-2-((2-methylphenyl)phenylmethoxy)-, (+-)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

    76. Orphenadrine Citrate [ep Impurity]

    77. Orphenadrine Citrate [orange Book]

    78. Smr000058817

    79. Orphenadrine Citrate [ep Monograph]

    80. Orphenadrine Citrate [usp Monograph]

    81. Ft-0655842

    82. Ft-0673305

    83. S2054

    84. Sw102176-4

    85. En300-53019

    86. Norgesic Component Orphenadrine Citrate

    87. C75247

    88. D00774

    89. Invagesic Component Orphenadrine Citrate

    90. Orphenadrine Citrate Component Of Norgesic

    91. Orphengesic Component Orphenadrine Citrate

    92. A826945

    93. Orphenadrine Citrate Component Of Invagesic

    94. Orphenadrine Citrate Component Of Orphengesic

    95. Sr-01000002975-5

    96. Invagesic Forte Component Orphenadrine Citrate

    97. Orphengesic Forte Component Orphenadrine Citrate

    98. Q27107584

    99. Orphenadrine Citrate Component Of Invagesic Forte

    100. Orphenadrine Citrate Component Of Orphengesic Forte

    101. Beta-dimethylaminoethyl 2-methylbenzhydryl Ether Citrate Salt

    102. N,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate

    103. (+-)-n,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate

    104. (+/-)-n,n-dimethyl-2-((o-methyl-.alpha.-phenylbenzyl)oxy)ethylamine Citrate (1:1)

    105. Ethanamine, N,n-dimethyl-2-((2-methylphenyl)phenylmethoxy)-, (+/-)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

    106. Ethanamine, N,n-dimethyl-2-[(2-methylphenyl)phenylmethoxy]-,2-hydroxy-1,2,3-propanetricarboxylate (1:1)

    107. N,n-dimethyl-2-[(2-methylphenyl)(phenyl)methoxy]ethanamine 2-hydroxypropane-1,2,3-tricarboxylate

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 461.5 g/mol
    Molecular Formula C24H31NO8
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count11
    Exact Mass461.20496695 g/mol
    Monoisotopic Mass461.20496695 g/mol
    Topological Polar Surface Area145 Ų
    Heavy Atom Count33
    Formal Charge0
    Complexity488
    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 4  
    Drug NameNorflex
    PubMed HealthOrphenadrine
    Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
    Drug LabelOrphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2- methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly solubl...
    Active IngredientOrphenadrine citrate
    Dosage FormInjectable
    RouteInjection
    Strength30mg/ml
    Market StatusPrescription
    CompanyMedicis

    2 of 4  
    Drug NameOrphenadrine citrate
    PubMed HealthOrphenadrine Citrate/Aspirin/Caffeine (By mouth)
    Drug ClassesSkeletal Muscle Relaxant, Centrally Acting/Salicylate, Aspirin Combination
    Drug LabelOrphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate i...
    Active IngredientOrphenadrine citrate
    Dosage FormTablet, extended release; Injectable
    RouteInjection; Oral
    Strength30mg/ml; 100mg
    Market StatusPrescription
    CompanyImpax Pharms; Tedor Pharma; Sandoz; Invagen Pharms; Watson Labs; Gavis Pharms; Sagent Pharms; Eurohlth Intl; Akorn

    3 of 4  
    Drug NameNorflex
    PubMed HealthOrphenadrine
    Drug ClassesSkeletal Muscle Relaxant, Centrally Acting
    Drug LabelOrphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2- methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly solubl...
    Active IngredientOrphenadrine citrate
    Dosage FormInjectable
    RouteInjection
    Strength30mg/ml
    Market StatusPrescription
    CompanyMedicis

    4 of 4  
    Drug NameOrphenadrine citrate
    PubMed HealthOrphenadrine Citrate/Aspirin/Caffeine (By mouth)
    Drug ClassesSkeletal Muscle Relaxant, Centrally Acting/Salicylate, Aspirin Combination
    Drug LabelOrphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate i...
    Active IngredientOrphenadrine citrate
    Dosage FormTablet, extended release; Injectable
    RouteInjection; Oral
    Strength30mg/ml; 100mg
    Market StatusPrescription
    CompanyImpax Pharms; Tedor Pharma; Sandoz; Invagen Pharms; Watson Labs; Gavis Pharms; Sagent Pharms; Eurohlth Intl; Akorn

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Cytochrome P-450 CYP2B6 Inhibitors

    Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP2B6. (See all compounds classified as Cytochrome P-450 CYP2B6 Inhibitors.)

    Antiparkinson Agents

    Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)

    Muscarinic Antagonists

    Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)

    Muscle Relaxants, Central

    A heterogeneous group of drugs used to produce muscle relaxation, excepting the neuromuscular blocking agents. They have their primary clinical and therapeutic uses in the treatment of muscle spasm and immobility associated with strains, sprains, and injuries of the back and, to a lesser degree, injuries to the neck. They have been used also for the treatment of a variety of clinical conditions that have in common only the presence of skeletal muscle hyperactivity, for example, the muscle spasms that can occur in MULTIPLE SCLEROSIS. (From Smith and Reynard, Textbook of Pharmacology, 1991, p358) (See all compounds classified as Muscle Relaxants, Central.)

    Parasympatholytics

    Agents that inhibit the actions of the parasympathetic nervous system. The major group of drugs used therapeutically for this purpose is the MUSCARINIC ANTAGONISTS. (See all compounds classified as Parasympatholytics.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Muscle Relaxant [EPC]; Centrally-mediated Muscle Relaxation [PE]
    5.3 ATC Code

    M - Musculo-skeletal system

    M03 - Muscle relaxants

    M03B - Muscle relaxants, centrally acting agents

    M03BC - Ethers, chemically close to antihistamines

    M03BC01 - Orphenadrine (citrate)

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    04-Jan-2022
    19-Jun-2025
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    ABOUT THIS PAGE

    Looking for 4724-58-7 / Orphenadrine API manufacturers, exporters & distributors?

    Orphenadrine manufacturers, exporters & distributors 1

    31

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

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

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

    API | Excipient name

    Orphenadrine

    Synonyms

    4682-36-4, Norflex, Banflex, Orphenadrine dihydrogen citrate, Flexon, Orphenadrine (citrate)

    Cas Number

    4724-58-7

    Unique Ingredient Identifier (UNII)

    X0A40N8I4S

    About Orphenadrine

    A muscarinic antagonist used to treat drug-induced parkinsonism and to relieve pain from muscle spasm.

    Orphenadrine citrate (Norflex) Manufacturers

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

    Orphenadrine citrate (Norflex) Suppliers

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

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

    Orphenadrine citrate (Norflex) USDMF

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

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

    click here to find a list of Orphenadrine citrate (Norflex) suppliers with USDMF on PharmaCompass.

    Orphenadrine citrate (Norflex) KDMF

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

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

    After submitting a Orphenadrine citrate (Norflex) 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 Orphenadrine citrate (Norflex) API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Orphenadrine citrate (Norflex) suppliers with KDMF on PharmaCompass.

    Orphenadrine citrate (Norflex) CEP

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

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

    Orphenadrine citrate (Norflex) WC

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

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

    Orphenadrine citrate (Norflex) 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 Orphenadrine citrate (Norflex) as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Orphenadrine citrate (Norflex) suppliers with NDC on PharmaCompass.

    Orphenadrine citrate (Norflex) GMP

    Orphenadrine citrate (Norflex) 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 Orphenadrine citrate (Norflex) 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 Orphenadrine citrate (Norflex) GMP manufacturer or Orphenadrine citrate (Norflex) GMP API supplier for your needs.

    Orphenadrine citrate (Norflex) CoA

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

    Orphenadrine citrate (Norflex) CoA mostly includes findings from lab analyses of a specific batch. For each Orphenadrine citrate (Norflex) 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.

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