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Health Care Active Pharmaceutical Ingredients:
Polyethylene Glycols


PEG APIs: Excellence in Pharmaceutical Applications

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.

Clariant Image Baking Soda 20221101

This type of laxative formulation thus improves quality of life for millions around the world, as part of treatment for chronic constipation in adults and children, during pregnancy, before or after surgery or as preparation for colonoscopy continue to improve people’s health.

Our laxative API PEGs are compliant with the general requirements of three of the most important international pharmacopoeias (the European Pharmacopoeia (Ph. Eur.), the United States Pharmacopoeia–National Formulary (USP-NF), and the Japanese Pharmacopoeia (JP)). With more than 30 years experience as a producer, we maintain very rigorous production standards. We use dedicated reactors to avoid cross contamination and our production facilities undergo comprehensive audits for GMP compliance.

PEG API as GMP-compliant demulcent for ophthalmic solutions

Without the right tear composition and amount, people may suffer from conditions which can cause stinging, burning, fatigue and redness of the eyes. Factors such as contact lens wear, increased visual display use and environmental exposure have led to a significant increase in the incidence of eye conditions within modern society1, 2. Lubricant eye drops containing PEG 400 provide temporary relief to the patient. PEG 400 provides a lubrication effect and acts as a demulcent active pharmaceutical ingredient (API) in such formulations3. In the sensitive eye area, high quality ingredients are required in ophthalmic formulations.


Clariant's Polyglykol 400 Jserves 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.

1. Stapleton F et al. TFOS DEWS II Epidemiology report. The Ocular Surface 15 (2017) 334-365. 2. Perry HD. Dry Eye Disease: Pathophysiology, Classification and Diagnosis. American Journal for Managed Care 2008;14: 79 – 87 3. 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).

Clariant Image Eyedrop in blue transparent container 20220823

Excellence in production

Clariant is committed on Excellence in production with a global production, technical and regulatory footprint. Clariant also offers PEGs as APIs in various physical forms
  • Flakes
  • Sprayed powders
  • Milled powders

Related products

  • Polyglykol 3350 P*
    Polyglykol 3350 P is a milled PEG API grade powder product, produced under ICH Q7 conditions with GMP certification by the German authorities.The powder form supports the homogeneous mixing with other materials within production. It is specified according to the requirements of the main international ICH guidelines and monographs (see below). * only in combination with a Pharma CoA
    更多信息
  • Polyglykol 3350 PS
    Polyglykol 3350 PS is a sprayed PEG API grade powder product, with a mean particle size distribution. It is produced under ICH Q7 conditions and GMP certified by the German authorities. The powder form supports the homogeneous mixing with other powder materials within production resulting into powder mixtures with improved flowability. It is specified according to the requirements of the main international ICH guidelines and monographs (see below).
    更多信息
  • Polyglykol 3350 PSB
    Polyglykol 3350 PS is a sprayed PEG API grade powder product, with a coarse particle size distribution. It is produced under ICH Q7 conditions and GMP certified by the German authorities. The powder form supports the homogeneous mixing with other powder materials within production resulting into powder mixtures with improved flowability. It is specified according to the requirements of the main international ICH guidelines and monographs (see below).
    更多信息
  • Polyglykol 3350 PSE
    Polyglykol 3350 PSE is a sprayed PEG API grade powder product, with a mean particle size distribution. It is produced under ICH Q7 conditions and GMP certified by the German authorities. The powder form supports the homogeneous mixing with other powder materials within production resulting into powder mixtures with improved flowability. It is specified according to the requirements of the main international ICH guidelines and monographs (see below).With its low Ethylene oxide and Dioxane specification limits special formulation requirements could be fulfilled.
    更多信息
  • Polyglykol 3350 PSR
    Polyglykol 3350 PSR is a sprayed PEG API grade powder product, with a coarse particle size distribution. It is produced under ICH Q7 conditions and GMP certified by the German authorities. The powder form supports the homogeneous mixing with other powder materials within production resulting into powder mixtures with improved flowability. It is specified according to the requirements of the main international ICH guidelines and monographs (see below).With its low Ethylene oxide and Dioxane specification limits special formulation requirements could be fulfilled.
    更多信息
  • Polyglykol 3350 PST
    Polyglykol 3350 PST is a sprayed PEG API grade powder product, with a fine particle size distribution. It is produced under ICH Q7 conditions and GMP certified by the German authorities. The powder form supports the homogeneous mixing with other powder materials within production resulting into powder mixtures with improved flowability. It is specified according to the requirements of the main international ICH guidelines and monographs (see below).With its low Ethylene oxide and Dioxane specification limits special formulation requirements could be fulfilled.
    更多信息
  • Polyglykol 3350 S*
    Polyglykol 3350 S is a flaked PEG API grade powder product, produced under ICH Q7 conditions with GMP certification by the German authorities.The flaked form enables easier handling of the material within production. It is specified according to the requirements of the main international ICH guidelines and monographs (see below). * only in combination with a Pharma CoA
    更多信息
  • 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).
    更多信息
  • Polyglykol 4000 P*
    Polyglykol 4000 P is a milled PEG API grade powder product, produced under ICH Q7 conditions with GMP certification by the German authorities.The powder form supports the homogeneous mixing with other materials within production. It is specified according to the requirements of the main international ICH guidelines and monographs (see below). * only in combination with a Pharma CoA
    更多信息
  • Polyglykol 4000 PS
    Polyglykol 4000 PS is a sprayed PEG API grade powder product, with a mean particle size distribution. It is produced under ICH Q7 conditions and GMP certified by the German authorities. The powder supports the homogeneous mixing with other powder materials within production. It is specified according to the requirements of the main international ICH guidelines and monographs (see below).
    更多信息
  • Polyglykol 4000 S*
    Polyglykol 4000 S is a flaked PEG API grade powder product, produced under ICH Q7 conditions with GMP certification by the German authorities.The flaked form enables easier handling of the material within production. It is specified according to the requirements of the main international ICH guidelines and monographs (see below). * only in combination with a Pharma CoA
    更多信息

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