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  4. Super Refined PEG 400

Super Refined™ PEG 400

Chemical Description

Polyethylene Glycol 400

Product Description

Super Refined PEGs are solvents for use with the most sensitive active ingredients across dosage forms including injectable and oral. Super Refining removes polar impurities (including primary and secondary oxidation products) from an excipient without altering its chemical composition, reducing excipient-API interaction and subsequent API degradation. The benefits of Super Refined PEGs over standard pharmaceutical PEGs include: • Better API stability and finished formulation integrity • Reduced potential for cellular irritation • Improved taste profile when used in oral liquid dosage forms • Reduced crosslinking in gelatin capsules Please download the datasheet for more detailed information.

Pharmacopoeia Compliance

  • FDA-IID Listed
  • JP
  • PhEur
  • USP/NF
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  • Details
  • Properties
  • (15) Literature
Chemical Group
  • Ethoxylate
  • Polyethylene glycol
Market Application
  • Human Pharmaceutical
  • Veterinary Health
Functions
  • Solvent
Administration Route
  • Auricular
  • Nasal
  • Ophthalmic
  • Oral
  • Parenteral
  • Rectal and Vaginal
  • Topical
Typical Properties
Physical Form
  • Colourless viscous liquid
Literature

Super Refined PEG

The Super Refined PEG range is a series of Super Refined polyethylene glycols, offering pharmaceutical formulators highly purified hydrophilic excipients that can enhance active and formulation stability. Croda’s proprietary Super Refining process removes polar impurities, eliminating their adverse interactions with active pharmaceutical ingredients (APIs). The Super Refined PEG range is particularly suitable for use in gelatin capsules, as Super Refining removes the impurities that cause gelatin cross-linking and impaired drug dissolution

Language: English | Type: Data Sheet | Size: 644kb

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Purity of PEG 400 Affects API Stability

PEG 400 purity is critical for maintaining the stability and integrity of an API.

Language: English | Type: Poster | Size: 0kb

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Super Refined PEG 400

Super Refined PEG 400 is the first in a range of Super Refined polyethylene glycols, and as such, offers pharmaceutical formulators the advantages of Croda’s proprietary Super Refining process and the benefits of a highly purified excipient. Super Refining is a technique that removes polar impurities, such as peroxide species, aldehydes and ketones. Removal of these polar impurities eliminates their adverse interaction with Active Pharmaceutical Ingredients (APIs), thereby, enhancing the stability of the drug and/or the vehicle itself. The improved taste profile of Super Refined PEG 400 versus its standard compendial counterpart will also enable formulators to design more palatable oral liquid medicines. Croda has been supplying its range of highly purified Super Refined triglyceride oils to the pharmaceutical industry for many years.

Language: English | Type: Data Sheet | Size: 409.88kb

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High Purity Excipients

Looking to enhance the bioavailability, delivery and efficacy of your dosage form? Our high purity excipients optimise the stability of your API and the performance of your formulations.

Language: English | Type: Brochure | Size: 538.5kb

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Purity of PEG 400 Effects the Stability of Gelatin Capsules

Objective of the study is to determine whether the lower impurity profile of Super Refined PEG 400 increased gelatin capsule stability compared to Pharmaceutical grade PEG 400.

Language: English | Type: Poster | Size: 734.72kb

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Super Refined PEG 400

Language: Spanish | Type: Product Overview Sheets | Size: 563kb

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Super Refined PEG

Language: Spanish | Type: Data Sheet | Size: 563kb

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Super Refined PEG 400

Language: Portuguese | Type: Product Overview Sheets | Size: 398kb

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Super Refined PEG 400

Language: Portuguese | Type: Data Sheet | Size: 479kb

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Topical Dosage Form Excipients

Language: Portuguese | Type: Data Sheet | Size: 519kb

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FDA Vaginal/Rectal Chart

Language: Portuguese | Type: Poster | Size: 311kb

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Topical Dosage Form Excipients

Language: Spanish | Type: Data Sheet | Size: 138kb

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Solubility Guide - Optimising Formulation Success

As API solubility continues to present challenges for the pharmaceutical formulator, in order to address this we have determined the solubility of a range of actives in a number of our high purity excipients. This baseline of information can provide you, the scientist, with a clearer starting point for your development work. Within this solubility guide, the solubility of 12 drug actives was determined using a range of our excipients for the purpose of demonstrating our capabilities to solubilise APIs.

Language: English | Type: Brochure | Size: 830.21kb

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Excipient Purity - API Stability

The choice of pharmaceutical excipients can play a critical role in enhancing formulation stability. At Croda, our highly purified ingredients are designed to reduce the risk of product degradation, improving the chances of successful formulation development.

Language: English | Type: Brochure | Size: 494kb

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Super Refined PEG - API Stability

Stability of APIs in Super Refined PEG.

Language: English | Type: Brochure | Size: 368kb

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