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Chemistry

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Also known as: Pramlintide acetate [usan], Schembl238214, Unii-726i6te06g, Aco137, 726i6te06g, 25-l-proline-28-l-proline-29-l-proline-, acetate (salt), hydrate
Molecular Formula
C171H269N51O53S2
Molecular Weight
3951  g/mol
InChI Key
NRKVKVQDUCJPIZ-MKAGXXMWSA-N

Pramlintide
Pramlintide Acetate is the acetate salt form of pramlintide, a peptide analogue of human amylin with 3 proline substitutions at position 25, 28 and 29, with antihyperglycemic activity. By mimicking amylin, pramlintide slows gastric emptying, inhibits digestive secretions (gastric acid, pancreatic enzymes, and bile), reduces glucagon secretion, and increases satiety; all of these actions are mediated mostly by glucose-sensitive areas in the brain stem. The overall result is a decrease in blood glucose levels. The use of pramlintide may cause an increased risk of insulin-induced hypoglycemia.
1 2D Structure

Pramlintide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-N-[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(2S)-4-amino-1-[[(2S)-1-[[2-[(2S)-2-[[(2S,3S)-1-[[(2S)-1-[(2S)-2-[(2S)-2-[[(2S,3R)-1-[[(2S)-4-amino-1-[[(2S)-1-[[2-[[(2S)-1-[[(2S)-4-amino-1-[[(2S,3R)-1-[[(2S)-1-amino-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-2-oxoethyl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]carbamoyl]pyrrolidine-1-carbonyl]pyrrolidin-1-yl]-4-methyl-1-oxopentan-2-yl]amino]-3-methyl-1-oxopentan-2-yl]carbamoyl]pyrrolidin-1-yl]-2-oxoethyl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-(1H-imidazol-5-yl)-1-oxopropan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-1-oxopropan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-5-carbamimidamido-1-oxopentan-2-yl]-2-[[(2S,3R)-2-[[(2S)-2-[[(2R)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-4-amino-2-[[(2R)-2-[[(2S)-2,6-diaminohexanoyl]amino]-3-sulfanylpropanoyl]amino]-4-oxobutanoyl]amino]-3-hydroxybutanoyl]amino]propanoyl]amino]-3-hydroxybutanoyl]amino]-3-sulfanylpropanoyl]amino]propanoyl]amino]-3-hydroxybutanoyl]amino]pentanediamide
2.1.2 InChI
InChI=1S/C171H269N51O53S2/c1-21-81(12)130(163(268)207-110(56-78(6)7)169(274)222-53-33-42-118(222)170(275)221-52-32-41-117(221)160(265)219-135(89(20)230)167(272)206-109(66-125(180)238)151(256)212-128(79(8)9)161(266)186-68-126(239)192-111(70-223)154(259)203-107(64-123(178)236)152(257)218-134(88(19)229)166(271)195-98(136(181)241)57-92-43-45-94(231)46-44-92)214-159(264)116-40-31-51-220(116)127(240)69-187-141(246)101(58-90-34-24-22-25-35-90)199-148(253)105(62-121(176)234)201-149(254)106(63-122(177)235)202-155(260)112(71-224)209-156(261)113(72-225)208-146(251)103(60-93-67-184-75-188-93)205-162(267)129(80(10)11)213-150(255)100(55-77(4)5)198-145(250)102(59-91-36-26-23-27-37-91)200-147(252)104(61-120(175)233)196-137(242)82(13)189-144(249)99(54-76(2)3)197-142(247)96(39-30-50-185-171(182)183)193-143(248)97(47-48-119(174)232)194-165(270)132(86(17)227)215-138(243)83(14)190-157(262)114(73-276)211-168(273)133(87(18)228)216-139(244)84(15)191-164(269)131(85(16)226)217-153(258)108(65-124(179)237)204-158(263)115(74-277)210-140(245)95(173)38-28-29-49-172/h22-27,34-37,43-46,67,75-89,95-118,128-135,223-231,276-277H,21,28-33,38-42,47-66,68-74,172-173H2,1-20H3,(H2,174,232)(H2,175,233)(H2,176,234)(H2,177,235)(H2,178,236)(H2,179,237)(H2,180,238)(H2,181,241)(H,184,188)(H,186,266)(H,187,246)(H,189,249)(H,190,262)(H,191,269)(H,192,239)(H,193,248)(H,194,270)(H,195,271)(H,196,242)(H,197,247)(H,198,250)(H,199,253)(H,200,252)(H,201,254)(H,202,260)(H,203,259)(H,204,263)(H,205,267)(H,206,272)(H,207,268)(H,208,251)(H,209,261)(H,210,245)(H,211,273)(H,212,256)(H,213,255)(H,214,264)(H,215,243)(H,216,244)(H,217,258)(H,218,257)(H,219,265)(H4,182,183,185)/t81-,82-,83-,84-,85+,86+,87+,88+,89+,95-,96-,97-,98-,99-,100-,101-,102-,103-,104-,105-,106-,107-,108-,109-,110-,111-,112-,113-,114-,115-,116-,117-,118-,128-,129-,130-,131-,132-,133-,134-,135-/m0/s1
2.1.3 InChI Key
NRKVKVQDUCJPIZ-MKAGXXMWSA-N
2.1.4 Canonical SMILES
CCC(C)C(C(=O)NC(CC(C)C)C(=O)N1CCCC1C(=O)N2CCCC2C(=O)NC(C(C)O)C(=O)NC(CC(=O)N)C(=O)NC(C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(CC(=O)N)C(=O)NC(C(C)O)C(=O)NC(CC3=CC=C(C=C3)O)C(=O)N)NC(=O)C4CCCN4C(=O)CNC(=O)C(CC5=CC=CC=C5)NC(=O)C(CC(=O)N)NC(=O)C(CC(=O)N)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CC6=CN=CN6)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC7=CC=CC=C7)NC(=O)C(CC(=O)N)NC(=O)C(C)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(CCC(=O)N)NC(=O)C(C(C)O)NC(=O)C(C)NC(=O)C(CS)NC(=O)C(C(C)O)NC(=O)C(C)NC(=O)C(C(C)O)NC(=O)C(CC(=O)N)NC(=O)C(CS)NC(=O)C(CCCCN)N
2.1.5 Isomeric SMILES
CC[C@H](C)[C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N1CCC[C@H]1C(=O)N2CCC[C@H]2C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H](C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC3=CC=C(C=C3)O)C(=O)N)NC(=O)[C@@H]4CCCN4C(=O)CNC(=O)[C@H](CC5=CC=CC=C5)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H](CC6=CN=CN6)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC7=CC=CC=C7)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](C)NC(=O)[C@H](CS)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](C)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](CS)NC(=O)[C@H](CCCCN)N
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Ac 0137

2. Ac 137

3. Lys-cys-asn-thr-ala-thr-cys-ala-thr-gln-arg-leu-ala-asn-phe-leu-val-his-ser-ser-asn-asn-phe-gly-pro-ile-leu-pro-pro-thr-asn-val-gly-ser-asn-thr-tyr-nh2

4. Pramlintide

5. Pramlintide Acetate

6. Tripro-amylin

2.2.2 Depositor-Supplied Synonyms

1. Pramlintide Acetate [usan]

2. Schembl238214

3. Unii-726i6te06g

4. Aco137

5. 726i6te06g

6. 25-l-proline-28-l-proline-29-l-proline-, Acetate (salt), Hydrate

7. 25-l-proline-28-l-proline-29-l-prolineamylin (human) Acetate (salt), Hydrate

2.3 Create Date
2007-07-03
3 Chemical and Physical Properties
Molecular Weight 3951 g/mol
Molecular Formula C171H269N51O53S2
XLogP3-16.7
Hydrogen Bond Donor Count58
Hydrogen Bond Acceptor Count59
Rotatable Bond Count122
Exact Mass3949.9396798 g/mol
Monoisotopic Mass3948.9363250 g/mol
Topological Polar Surface Area1690 Ų
Heavy Atom Count277
Formal Charge0
Complexity9620
Isotope Atom Count0
Defined Atom Stereocenter Count41
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameSymlin
PubMed HealthPramlintide (Injection)
Drug ClassesAntidiabetic
Active IngredientPramlintide acetate
Dosage FormInjectable
RouteSubcutaneous
Strengtheq 1.5mg base/1.5ml (eq 1mg base/ml); eq 2.7mg base/2.7ml (eq 1mg base/ml)
Market StatusPrescription
CompanyAstrazeneca Ab

2 of 2  
Drug NameSymlin
PubMed HealthPramlintide (Injection)
Drug ClassesAntidiabetic
Active IngredientPramlintide acetate
Dosage FormInjectable
RouteSubcutaneous
Strengtheq 1.5mg base/1.5ml (eq 1mg base/ml); eq 2.7mg base/2.7ml (eq 1mg base/ml)
Market StatusPrescription
CompanyAstrazeneca Ab

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Hypoglycemic Agents

Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)


DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;SUBCUTANEOUS - EQ 1.5MG B...DOSAGE - INJECTABLE;SUBCUTANEOUS - EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)

USFDA APPLICATION NUMBER - 21332

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DOSAGE - INJECTABLE;SUBCUTANEOUS - EQ 2.7MG B...DOSAGE - INJECTABLE;SUBCUTANEOUS - EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)

USFDA APPLICATION NUMBER - 21332

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ABOUT THIS PAGE

Pramlintide Manufacturers

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

Pramlintide Suppliers

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

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

Pramlintide USDMF

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

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

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

Pramlintide 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 Pramlintide as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Pramlintide GMP

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

Pramlintide CoA

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

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

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