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Degludec

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Chemistry

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Also known as: 844439-96-9, Degludec, Tresiba, Insulin degludec [usan:inn], Unii-54q18076qb, Nn 1250

Molecular Formula

C₂₇₄H₄₁₁N₆₅O₈₁S₆

Molecular Weight

6104 g/mol

InChI Key

FYZPCMFQCNBYCY-WIWKJPBBSA-N

Insulin Degludec is a recombinant, long-acting analog of human insulin, with blood glucose-lowering activity. Upon subcutaneous injection, insulin degludec forms a multi-hexameric depot from which insulin monomers are slowly released into the systemic circulation. Insulin regulates glucose metabolism by binding to insulin receptors on muscle and fat cells, which stimulates the cellular uptake of glucose and lowers blood glucose levels. Insulin inhibits the liver's conversion of stored glycogen into glucose, which also contributes to lower blood glucose levels. In addition, insulin inhibits lipolysis in adipose tissue, inhibits proteolysis, and enhances protein synthesis. Insulin degludec doesn't contain the amino acid threonine that is found at position B30 in human insulin; additionally, the lysine at position B29 is conjugated to hexadecanedioic acid, which allows the formation of the multi-hexamers upon subcutaneous injection. The phenol and zinc present in the pharmaceutical formulation promote a di-hexameric state of insulin degludec.

1 2D Structure

Degludec

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

16-[[(1S)-4-[[(5S)-5-[[(2S)-1-[(2S,3R)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[2-[[(2S)-2-[[(2S)-2-[[2-[[(1R,6R,12S,15S,18S,21S,24S,27S,30S,33S,36S,39S,42R,47R,50S,53S,56S,59S,62S,65S,68S,71S,74R,77S,80S,83S,88R)-88-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S,3S)-2-[(2-aminoacetyl)amino]-3-methylpentanoyl]amino]-3-methylbutanoyl]amino]-4-carboxybutanoyl]amino]-5-oxopentanoyl]amino]-6-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[(2S)-4-amino-2-[[(2S)-2-[[(2S)-2-amino-3-phenylpropanoyl]amino]-3-methylbutanoyl]amino]-4-oxobutanoyl]amino]-5-oxopentanoyl]amino]-3-(1H-imidazol-4-yl)propanoyl]amino]-4-methylpentanoyl]amino]-47-[[(1S)-3-amino-1-carboxy-3-oxopropyl]carbamoyl]-53-(2-amino-2-oxoethyl)-62-(3-amino-3-oxopropyl)-77-[(2S)-butan-2-yl]-24,56-bis(2-carboxyethyl)-83-[(1R)-1-hydroxyethyl]-12,71,80-tris(hydroxymethyl)-33,50,65-tris[(4-hydroxyphenyl)methyl]-15-(1H-imidazol-4-ylmethyl)-27-methyl-18,30,36,59,68-pentakis(2-methylpropyl)-7,10,13,16,19,22,25,28,31,34,37,40,49,52,55,58,61,64,67,70,73,76,79,82,85,87-hexacosaoxo-21,39-di(propan-2-yl)-3,4,44,45,90,91-hexathia-8,11,14,17,20,23,26,29,32,35,38,41,48,51,54,57,60,63,66,69,72,75,78,81,84,86-hexacosazabicyclo[72.11.7]dononacontane-42-carbonyl]amino]acetyl]amino]-4-carboxybutanoyl]amino]-5-carbamimidamidopentanoyl]amino]acetyl]amino]-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-hydroxybutanoyl]pyrrolidine-2-carbonyl]amino]-5-carboxypentyl]amino]-1-carboxy-4-oxobutyl]amino]-16-oxohexadecanoic acid

2.1.2 InChI

InChI=1S/C274H411N65O81S6/c1-28-146(23)223(331-210(357)119-275)268(412)335-222(145(21)22)264(408)305-172(89-97-218(369)370)234(378)300-169(84-92-204(279)351)238(382)326-198-131-424-425-132-199-259(403)323-193(126-341)256(400)312-177(103-138(7)8)241(385)313-183(110-154-66-74-160(345)75-67-154)244(388)301-167(82-90-202(277)349)235(379)308-176(102-137(5)6)239(383)303-171(88-96-217(367)368)237(381)320-189(116-205(280)352)251(395)316-185(112-156-70-78-162(347)79-71-156)247(391)327-197(258(402)322-191(273(419)420)118-207(282)354)130-423-422-129-196(231(375)290-122-211(358)295-166(86-94-215(363)364)233(377)299-165(62-53-99-288-274(283)284)229(373)289-123-212(359)297-181(108-152-57-45-41-46-58-152)243(387)315-182(109-153-59-47-42-48-60-153)246(390)317-186(113-157-72-80-163(348)81-73-157)254(398)338-226(150(27)344)270(414)339-100-54-63-201(339)262(406)306-173(271(415)416)61-51-52-98-287-208(355)93-85-174(272(417)418)296-209(356)64-49-38-36-34-32-30-31-33-35-37-39-50-65-214(361)362)329-266(410)221(144(19)20)334-252(396)179(105-140(11)12)310-245(389)184(111-155-68-76-161(346)77-69-155)314-240(384)175(101-136(3)4)307-227(371)148(25)294-232(376)170(87-95-216(365)366)304-263(407)220(143(17)18)333-253(397)180(106-141(13)14)311-249(393)188(115-159-121-286-135-293-159)319-255(399)192(125-340)298-213(360)124-291-230(374)195(128-421-426-133-200(328-260(198)404)261(405)337-225(149(26)343)269(413)324-194(127-342)257(401)336-224(147(24)29-2)267(411)330-199)325-242(386)178(104-139(9)10)309-248(392)187(114-158-120-285-134-292-158)318-236(380)168(83-91-203(278)350)302-250(394)190(117-206(281)353)321-265(409)219(142(15)16)332-228(372)164(276)107-151-55-43-40-44-56-151/h40-48,55-60,66-81,120-121,134-150,164-201,219-226,340-348H,28-39,49-54,61-65,82-119,122-133,275-276H2,1-27H3,(H2,277,349)(H2,278,350)(H2,279,351)(H2,280,352)(H2,281,353)(H2,282,354)(H,285,292)(H,286,293)(H,287,355)(H,289,373)(H,290,375)(H,291,374)(H,294,376)(H,295,358)(H,296,356)(H,297,359)(H,298,360)(H,299,377)(H,300,378)(H,301,388)(H,302,394)(H,303,383)(H,304,407)(H,305,408)(H,306,406)(H,307,371)(H,308,379)(H,309,392)(H,310,389)(H,311,393)(H,312,400)(H,313,385)(H,314,384)(H,315,387)(H,316,395)(H,317,390)(H,318,380)(H,319,399)(H,320,381)(H,321,409)(H,322,402)(H,323,403)(H,324,413)(H,325,386)(H,326,382)(H,327,391)(H,328,404)(H,329,410)(H,330,411)(H,331,357)(H,332,372)(H,333,397)(H,334,396)(H,335,412)(H,336,401)(H,337,405)(H,338,398)(H,361,362)(H,363,364)(H,365,366)(H,367,368)(H,369,370)(H,415,416)(H,417,418)(H,419,420)(H4,283,284,288)/t146-,147-,148-,149+,150+,164-,165-,166-,167-,168-,169-,170-,171-,172-,173-,174-,175-,176-,177-,178-,179-,180-,181-,182-,183-,184-,185-,186-,187-,188-,189-,190-,191-,192-,193-,194-,195-,196-,197-,198-,199-,200-,201-,219-,220-,221-,222-,223-,224-,225-,226-/m0/s1

2.1.3 InChI Key

FYZPCMFQCNBYCY-WIWKJPBBSA-N

2.1.4 Canonical SMILES

CCC(C)C1C(=O)NC2CSSCC(C(=O)NC(CSSCC(C(=O)NCC(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(CSSCC(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC2=O)CO)CC(C)C)CC3=CC=C(C=C3)O)CCC(=O)N)CC(C)C)CCC(=O)O)CC(=O)N)CC4=CC=C(C=C4)O)C(=O)NC(CC(=O)N)C(=O)O)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CC5=CC=CC=C5)C(=O)NC(CC6=CC=CC=C6)C(=O)NC(CC7=CC=C(C=C7)O)C(=O)NC(C(C)O)C(=O)N8CCCC8C(=O)NC(CCCCNC(=O)CCC(C(=O)O)NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(C)C)CC(C)C)CC9=CC=C(C=C9)O)CC(C)C)C)CCC(=O)O)C(C)C)CC(C)C)CC2=CNC=N2)CO)NC(=O)C(CC(C)C)NC(=O)C(CC2=CNC=N2)NC(=O)C(CCC(=O)N)NC(=O)C(CC(=O)N)NC(=O)C(C(C)C)NC(=O)C(CC2=CC=CC=C2)N)C(=O)NC(C(=O)NC(C(=O)N1)CO)C(C)O)NC(=O)C(CCC(=O)N)NC(=O)C(CCC(=O)O)NC(=O)C(C(C)C)NC(=O)C(C(C)CC)NC(=O)CN

2.1.5 Isomeric SMILES

CC[C@H](C)[C@H]1C(=O)N[C@H]2CSSC[C@@H](C(=O)N[C@@H](CSSC[C@@H](C(=O)NCC(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC2=O)CO)CC(C)C)CC3=CC=C(C=C3)O)CCC(=O)N)CC(C)C)CCC(=O)O)CC(=O)N)CC4=CC=C(C=C4)O)C(=O)N[C@@H](CC(=O)N)C(=O)O)C(=O)NCC(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)N[C@@H](CC5=CC=CC=C5)C(=O)N[C@@H](CC6=CC=CC=C6)C(=O)N[C@@H](CC7=CC=C(C=C7)O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N8CCC[C@H]8C(=O)N[C@@H](CCCCNC(=O)CC[C@@H](C(=O)O)NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(C)C)CC(C)C)CC9=CC=C(C=C9)O)CC(C)C)C)CCC(=O)O)C(C)C)CC(C)C)CC2=CNC=N2)CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC2=CNC=N2)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC2=CC=CC=C2)N)C(=O)N[C@H](C(=O)N[C@H](C(=O)N1)CO)[C@@H](C)O)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](C(C)C)NC(=O)[C@H]([C@@H](C)CC)NC(=O)CN

2.2 Synonyms

2.2.1 MeSH Synonyms

1. (1a-21a),(1b-29b)-insulin (human), 29b-(n6-(n-(15-carboxy-1- Oxopentadecyl)-l-gamma- Glutamyl)-l-lysine)-

2. Degludec

2.2.2 Depositor-Supplied Synonyms

1. 844439-96-9

2. Degludec

3. Tresiba

4. Insulin Degludec [usan:inn]

5. Unii-54q18076qb

6. Nn 1250

7. Nn1250

8. B29n(epsilon)-omega-carboxypentadecanoyl-gamma-l-glutamyl Desb30 Human Insulin

9. 54q18076qb

10. (1a-21a),(1b-29b)-insulin (human), 29b-(n6-(n-(15-carboxy-1-oxopentadecyl)-l-gamma- Glutamyl)-l-lysine)-

2.3 Create Date

2016-04-10

3 Chemical and Physical Properties

Molecular Formula	C₂₇₄H₄₁₁N₆₅O₈₁S₆
Molecular Weight	6104 g/mol
XLogP3	-4.9
Hydrogen Bond Donor Count	79
Hydrogen Bond Acceptor Count	92
Rotatable Bond Count	197
Exact Mass	6101.8431193 g/mol
Monoisotopic Mass	6099.8364096 g/mol
Topological Polar Surface Area	2510 Å²
Heavy Atom Count	426
Formal Charge	0
Complexity	15300
Isotope Atom Count	0
Defined Atom Stereocenter Count	51
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Indication

Insulin degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

FDA Label

Treatment of diabetes mellitus in adults.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Insulin is a natural hormone produced by beta cells of the pancreas. In non-diabetic individuals, the pancreas produces a continuous supply of low levels of basal insulin along with spikes of insulin following meals. Increased insulin secretion following meals is responsible for the metabolic changes that occur as the body transitions from a postabsorptive to absorptive state. Insulin promotes cellular uptake of glucose, particularly in muscle and adipose tissues, promotes energy storage via glycogenesis, opposes catabolism of energy stores, increases DNA replication and protein synthesis by stimulating amino acid uptake by the liver, muscle and adipose tissue, and modifies the activity of numerous enzymes involved in glycogen synthesis and glycolysis. Insulin also promotes growth and is required for the actions of growth hormone (e.g. protein synthesis, cell division, DNA synthesis). Insulin detemir is a long-acting insulin analogue with a flat and predictable action profile. It is used to mimic the basal levels of insulin in diabetic individuals. The onset of action of insulin detemir is 1 to 2 hours and its duration of action is up to 24 hours. Interestingly, it has a lower affinity (30%) for the insulin receptor than human insulin.

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Insulin [CS]; Insulin Analog [EPC]

5.3 ATC Code

A10AE06

A - Alimentary tract and metabolism

A10 - Drugs used in diabetes

A10A - Insulins and analogues

A10AE - Insulins and analogues for injection, long-acting

A10AE06 - Insulin degludec

5.4 Absorption, Distribution and Excretion

Absorption

In patients with type 1 diabetes, after 8 days of once daily subcutaneous dosing with 0.4 U/kg, maximum degludec concentrations of 4472 pmol/L were attained at a median of 9 hours (tmax). After the first dose of, median onset of appearance was around one hour. The glucose lowering effect lasted at least 42 hours after the last of 8 once-daily injections. Insulin degludec concentration reach steady state levels after 3-4 days.

Clearance

The mean apparent clearance of insulin degludec is 0.03 L/kg (2.1 L/h in 70 kg individual) after single subcutaneous dose of 0.4 units/kg.

5.5 Metabolism/Metabolites

All insulin degludec metabolites are inactive.

5.6 Biological Half-Life

The half-life after subcutaneous administration is determined primarily by the rate of absorption from the subcutaneous tissue. On average, the half-life at steady state is approximately 25 hours independent of dose.

5.7 Mechanism of Action

Insulin detemir binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor autophosphorylates and phosphorylates numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. Activation of these proteins leads to the activation of downstream signalling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC), both of which play critical roles in metabolism and catabolism.

API SUPPLIERS

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USDMF

01

Chongqing Chen'an Biopharmaceutical ...

Country

Pharma, Lab & Chemical Expo

Not Confirmed

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NDC API

01

Amphastar Nanjing Pharmaceuticals, ...

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

02

Novo Nordisk A/S

Denmark

Pharma, Lab & Chemical Expo

Not Confirmed

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Listed Suppliers

01

Hangzhou Jiuyuan Gene Engineering

China

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Not Confirmed

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Drugs in Development

01 Mannkind

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

Denmark

Pharma, Lab & Chemical Expo

Not Confirmed

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Denmark

Denmark

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Denmark

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Denmark

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Parenteral

01

Capital Farma

Spain

Pharma, Lab & Chemical Expo

Not Confirmed

Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.

Dosage Form : Injectable / Parenteral

Grade : Parenteral

Category : Parenteral

Brand Name : Metacresol

Application : Parenteral

Excipient Details : Metacresol (Synthetic) is used as a preservative and an antimicrobial agent in injectable formulations.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Metacresol Excipient

02

Pluviaendo

Turkey

Pharma, Lab & Chemical Expo

Not Confirmed

03

Actylis

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

04

Actylis

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

05

Actylis

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

Film Formers & Plasticizers

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Topical

Controlled & Modified Release

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ABOUT THIS PAGE

Degludec Manufacturers

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

Degludec Suppliers

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

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

Degludec USDMF

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

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

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Degludec 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 Degludec as an active pharmaceutical ingredient (API).

Finished drug products

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

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Degludec GMP

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

Degludec CoA

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

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

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