Laxatives & Colonic Lavage
Polyethylene Glycol Active Pharmaceutical Ingredients
We offer API PEGs with exceptional purity and consistency based on 40+ years of pharmaceutical manufacturing expertise. Our ICH Q7-compliant production facilities utilize dedicated reactors and undergo rigorous GMP audits, ensuring APIs that meet Ph. Eur. and USP-NF requirements across multiple physical forms.
Our CARBOWAX™ SENTRY™ Polyethylene Glycols (PEGs) 3350 and 4000 (Uninhibited) are active pharmaceutical ingredients (APIs) that are highly water soluble and used in multiple dosage forms.
- Ideal for osmotic laxative formulations for mild and effective treatment to relieve constipation for digestive health.
- Widely used in intestinal lavage formulations to facilitate bowel cleansing prior to medical procedures such as colonoscopies, radiological exams, or gastrointestinal surgery.
Solutions for laxative applications
A preferred API for laxative formulations
Best in class product features and manufacturing
World scale production facilities with dedicated reactors
Mild and effective treatment to relieve constipation
Consistency in taste and dissolution time
Dependable fill properties due to flow characteristics
Consistent bulk density, ensuring proper volume of product in your bottle or sachet
Complies with ICH Q7 guidelines for APIs
Global Registrations – CARBOWAX™ SENTRY™ PEG API
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| Country/Region | CARBOWAX™ SENTRY™ PEG 3350 (Uninhibited), Granular | CARBOWAX™ SENTRY™ PEG 3350 (Uninhibited), Powder | CARBOWAX™ SENTRY™ PEG 4000 (Uninhibited), Powder |
| United States | US DMF | US DMF | US DMF |
| Canada | CEP1 | CEP1 | CEP1 |
| European Union | CEP2 | CEP2 | CEP2 |
| China | DMF | DMF | DMF |
| Japan | DMF | ||
| Korea | DMF | ||
| Thailand | |||
| Technical Dossier: Chemistry, Manufacturing and Control (CMC) | CMC | ||
1 Guidance Document: Use of Certificates of Suitability (CEP) as supporting information in Drug Submissions (11.1)
2 Based on information received from regulatory authorities and trade associations, the following countries accept CEPs, some with conditions: Albania, Algeria, Australia, Azerbaijan, Canada, Georgia, Ghana Israel, Kyrgyzstan, Malaysia, Moldova, Morocco, New Zealand, Saudi Arabia, Singapore, South Africa, Tunisia, and Uzbekistan. CEPs are also accepted (with conditions) by the Taiwan Food and Drug Administration. Please note that this is not an exhaustive list
Product Details
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| Brand / Trade name | CARBOWAX™ SENTRY™ |
| Packaging size | 25 kg bag, 50 lb bag, 2000 lb supersack |
| UNI Numbers | 3WJQ0SDW1A, G2M7P15E5P |
| Physical Form | Granular & Powder |
| Chemical Name | Polyethylene glycol |
| Manufacturing Site | St. Charles Operations, Hahnville, Louisiana, US |
Example Osmotic Lavage Formulation for Oral Solution with Electrolytes
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| Ingredients |
| 59 g polyethylene glycol |
| 5.68 g sodium sulfate |
| 1.69 g sodium bicarbonate |
| 1.46 g sodium chloride |
| 0.745 g potassium chloride |
| Water to make up one liter |
* Leveraged from Patent # 6,946,149
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