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Chemistry

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Also known as: 5-[5-[3,4-dihydroxy-6-(hydroxymethyl)-5-methoxyoxan-2-yl]oxy-6-[[3,4-dihydroxy-6-(hydroxymethyl)-5-methoxyoxan-2-yl]oxymethyl]-3,4-dihydroxyoxan-2-yl]oxy-6-(hydroxymethyl)-2-methyloxane-3,4-diol
Molecular Formula
C27H48O20
Molecular Weight
692.7  g/mol
InChI Key
YJISHJVIRFPGGN-UHFFFAOYSA-N

Cornstarch
1 2D Structure

Cornstarch

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
5-[5-[3,4-dihydroxy-6-(hydroxymethyl)-5-methoxyoxan-2-yl]oxy-6-[[3,4-dihydroxy-6-(hydroxymethyl)-5-methoxyoxan-2-yl]oxymethyl]-3,4-dihydroxyoxan-2-yl]oxy-6-(hydroxymethyl)-2-methyloxane-3,4-diol
2.1.2 InChI
InChI=1S/C27H48O20/c1-8-13(31)14(32)23(11(6-30)42-8)46-27-20(38)17(35)24(47-26-19(37)16(34)22(40-3)10(5-29)44-26)12(45-27)7-41-25-18(36)15(33)21(39-2)9(4-28)43-25/h8-38H,4-7H2,1-3H3
2.1.3 InChI Key
YJISHJVIRFPGGN-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1C(C(C(C(O1)CO)OC2C(C(C(C(O2)COC3C(C(C(C(O3)CO)OC)O)O)OC4C(C(C(C(O4)CO)OC)O)O)O)O)O)O
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. 5-[5-[3,4-dihydroxy-6-(hydroxymethyl)-5-methoxyoxan-2-yl]oxy-6-[[3,4-dihydroxy-6-(hydroxymethyl)-5-methoxyoxan-2-yl]oxymethyl]-3,4-dihydroxyoxan-2-yl]oxy-6-(hydroxymethyl)-2-methyloxane-3,4-diol

2.3 Create Date
2008-07-11
3 Chemical and Physical Properties
Molecular Weight 692.7 g/mol
Molecular Formula C27H48O20
XLogP3-7.5
Hydrogen Bond Donor Count11
Hydrogen Bond Acceptor Count20
Rotatable Bond Count12
Exact Mass692.27389392 g/mol
Monoisotopic Mass692.27389392 g/mol
Topological Polar Surface Area306 Ų
Heavy Atom Count47
Formal Charge0
Complexity950
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count20
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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API Reference Price

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SAMPLE) CORNSTARCH NF","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"APOTEX INC","supplierCountry":"UNITED STATES","foreign_port":"TORONTO","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"158.76","actualQuantity":"158.76","unit":"KGS","unitRateFc":"8.6","totalValueFC":"998.1","currency":"CAD","unitRateINR":"530.6","date":"23-Nov-2024","totalValueINR":"84231.86","totalValueInUsd":"998.1","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"6836758","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"TORONTO","supplierAddress":"150 SIGNED DRIVE TORONTO ON M9L1T9 SDNF SDNF Canada","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"}]
30-Jun-2021
23-Nov-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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FDF Dossiers

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01

Esco Pharm

Armenia
Biotech Digital Meet
Not Confirmed
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Esco Pharm

Armenia
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Biotech Digital Meet
Not Confirmed

Clotrimazole; Zinc Oxide; Cornstarch; Talc API

Brand Name :

Dosage Form : Powder

Dosage Strength : 1GM; 10GM; 10GM; 79GM

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Armenia

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DATA COMPILATION #PharmaFlow

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Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination
The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   

Impressions: 2135

https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-roquette-seqens-evonik-make-strategic-moves-new-guidelines-deal-with-contamination

#PharmaFlow by PHARMACOMPASS
12 Sep 2024

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ABOUT THIS PAGE

Looking for 977050-93-3 / Cornstarch API manufacturers, exporters & distributors?

Cornstarch manufacturers, exporters & distributors 1

43

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

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

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

API | Excipient name

Cornstarch

Synonyms

5-[5-[3,4-dihydroxy-6-(hydroxymethyl)-5-methoxyoxan-2-yl]oxy-6-[[3,4-dihydroxy-6-(hydroxymethyl)-5-methoxyoxan-2-yl]oxymethyl]-3,4-dihydroxyoxan-2-yl]oxy-6-(hydroxymethyl)-2-methyloxane-3,4-diol

Cas Number

977050-93-3

Cornstarch Manufacturers

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

Cornstarch Suppliers

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

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

Cornstarch USDMF

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

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

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

Cornstarch CEP

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

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

Cornstarch GMP

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

Cornstarch CoA

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

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

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