Description

Lactulose USP

Lactulose USP is a high-purity, synthetic disaccharide conforming to United States Pharmacopeia standards, used as an active pharmaceutical ingredient (API) for the treatment of constipation and hepatic encephalopathy. As a non-absorbable sugar, it functions both as an osmotic laxative and as a therapeutic agent that reduces systemic ammonia levels in patients with compromised liver function.

• USP-compliant synthetic disaccharide composed of galactose and fructose
• Used in oral liquid preparations for chronic constipation and hepatic encephalopathy
• Exerts osmotic laxative effect by increasing stool water content
• Lowers colonic pH to convert ammonia into non-absorbable ammonium ions
• Manufactured under Good Manufacturing Practice (GMP) conditions
• Supplied with complete regulatory documentation including Certificate of Analysis (CoA), USP compliance, and supporting technical data

Lactulose USP is typically supplied as a viscous, colorless to pale-yellow syrup. It is not hydrolyzed or absorbed in the small intestine and undergoes bacterial fermentation in the colon. This produces low molecular weight organic acids, which draw water into the colon and acidify the environment, facilitating the conversion of ammonia (NH₃) to ammonium (NH₄⁺), reducing its systemic absorption.

In pharmaceutical applications, Lactulose USP is used in:

• Oral syrups or solutions for managing chronic or opioid-induced constipation
• Therapies for hepatic encephalopathy, especially in cirrhotic patients
• Neonatal and pediatric care where gentle and effective laxatives are required
• Long-term GI support in patients with reduced bowel motility or altered microbiota
• Prebiotic and colon-targeted formulations in emerging applications

Lactulose begins to act within 24–48 hours after oral administration and is considered safe for prolonged use under medical supervision. It is well-tolerated but may cause mild gastrointestinal side effects such as bloating or flatulence during early use.

CarboMer supplies Lactulose USP with precise control over sugar composition (including limits on galactose, lactose, epilactose, and fructose), microbial purity, and pH. Material is suitable for use in regulated human drug products and complies with USP monograph specifications.

The material is packaged in sealed, light-protective, tamper-evident containers suitable for viscous liquid APIs. Available in bulk and custom volumes. Minimum order quantities (MOQ), lead times, and complete documentation—including CoA and SDS—are available upon request.

Each batch is tested for identity (IR, HPLC), assay (lactulose content), specific gravity, pH, color, related sugars, and microbial limits. Certificates of Analysis (CoA), Safety Data Sheets (SDS), and full traceability documentation accompany every shipment.

As with all CarboMer gastrointestinal actives and osmotic agents, Lactulose USP is supported by regulatory expertise, formulation guidance, and a reliable supply chain to help you bring compliant, effective GI health therapies to market.