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Home / Products & Industries / Clariant Health Care / Clariant's Active Pharmaceutical Ingredients: Qual…
Health Care

We are in decades of pharmaceutical excellence

Clariant delivers pharmaceutical-grade PEGs with unmatched purity and consistency through 30+ years of manufacturing expertise. Our ICH Q7-compliant production facilities utilize dedicated reactors and undergo rigorous GMP audits, ensuring APIs that meet Ph.Eur., USP-NF, and JP requirements across multiple physical forms.

PEG APIs to bring constipation relief in Laxative formulations

Clariant's PEG-based laxative APIs work through an osmotic mechanism that retains water in the intestine, providing gentle, effective constipation relief. Our products offer significant advantages over alternative treatments: minimal absorption in the digestive tract, absence of side effects compared to lactulose, and suitability for long-term use—even in children as young as two years.

 

Key Advantages of Clariant PEG Laxative APIs:

  • Osmotic mechanism: Retains water in intestine for gentle, natural bowel movement
  • Minimal systemic absorption: PEG not absorbed in the digestive tract
  • No dependency: Suitable for long-term use unlike stimulant laxatives
  • Pediatric use: Clinically proven safe for children as young as 2 years
  • Fewer side effects: Better tolerated than lactulose (no bloating, cramping)
  • 30+ years expertise: Clariant's dedicated pharmaceutical PEG manufacturing
  • Full compliance: ICH Q7 GMP, Ph.Eur., USP-NF, JP monographs
Clariant Image Baking Soda 20221101

PEG API as GMP-compliant demulcent for ophthalmic solutions

Clariant's Polyglykol 400 J serves as a premium demulcent API in eye drop formulations, forming a protective layer over the ocular surface to relieve inflammation and irritation. This high-quality PEG mimics natural mucins, providing essential lubrication and viscosity for patients suffering from dry eye conditions caused by contact lens wear, digital screen use, and environmental factors. Our product meets stringent microbiological specifications, including endotoxin testing.

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PEG Laxative APIs

  <h3>What PEG molecular weight is used in osmotic laxatives?</h3>
  <p>PEG 3350 and PEG 4000 are the standard molecular weights used in osmotic laxative formulations. Clariant supplies both grades under the Polyglykol brand, manufactured in ICH Q7-compliant facilities with full pharmacopoeia documentation (Ph.Eur., USP-NF, JP).</p>
 
  <h3>How do PEG-based osmotic laxatives work?</h3>
  <p>PEG laxatives work through an osmotic mechanism: the PEG molecules retain water in the intestinal lumen, softening stool and stimulating natural bowel movements. Unlike stimulant laxatives, PEG laxatives do not cause dependency and are suitable for long-term use.</p>
 
  <h3>Are PEG laxatives safe for children?</h3>
  <p>Yes. PEG-based laxatives have been clinically proven safe for children as young as two years. The active ingredient shows minimal absorption in the digestive tract, making it well-tolerated with an absence of the side effects commonly associated with lactulose.</p>
 
  <h3>What GMP certifications does Clariant hold for PEG API manufacturing?</h3>
  <p>Clariant manufactures PEG APIs in dedicated reactors under ICH Q7-compliant GMP conditions. Facilities undergo rigorous audits and products meet Ph.Eur., USP-NF, and JP monograph requirements. Clariant has 30+ years of pharmaceutical PEG manufacturing expertise.</p>
 
  <h3>What is Polyglykol 400 J used for in ophthalmic applications?</h3>
  <p>Polyglykol 400 J is a pharmaceutical-grade PEG 400 used as a demulcent API in eye drop formulations. It forms a protective film over the ocular surface, mimicking natural mucins to relieve dry eye symptoms. The product meets stringent microbiological and endotoxin specifications required for ophthalmic use.</p>
 
  <h3>What is the difference between a PEG API and a PEG excipient?</h3>
  <p>A PEG API (Active Pharmaceutical Ingredient) is the therapeutically active component – e.g., PEG 3350 as an osmotic laxative. A PEG excipient is a functional additive that supports drug delivery (e.g., as a binder, solubilizer, or coating agent) without therapeutic effect. Clariant supplies both: PEG APIs (this page) and PEG excipients (VitiPure, Polyglykol ranges).</p>
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  • Polyglykol 400 J
    PEG 400 is described by the FDA as a possible demulcent in Ophthalmic Drug Products1. Polyglykol 400 J is a low molecular weight polyethylene glycol API type, which is produced under ICH Q7 GMP conditions, certified by the German authorities. With defined microbiological & endotoxin checks of the final packed product batch, which are given individually on the certificate of analysis, we would like to support you in your individual formulation risk assessment. 1. FDA, Final Administrative Order OTC000023, “Over-the-Counter Monograph 018: Ophthalmic Drug Products for Over-the-Counter Use,” Section M018.12(d)(3) (available at: https://dps.fda.gov/omuf/monographsearch/monograph_m018).
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