Psyllium husk is an official pharmacopoeial ingredient with monographs in the United States Pharmacopeia (USP), British Pharmacopoeia (BP), and European Pharmacopoeia (Ph. Eur.). Pharmaceutical manufacturers require psyllium that meets these specifications — not just food-grade quality standards.
What Does "Pharma Grade" Mean for Psyllium Husk?
Pharma grade psyllium husk meets specifications set by recognized pharmacopoeias and is manufactured under GMP (Good Manufacturing Practice) conditions. It requires stricter quality controls, lower microbial limits, tighter assay specifications, and GMP facility documentation compared to food-grade product.
USP Monograph (United States Pharmacopeia)
The USP Psyllium Husk monograph specifies: - Identification test confirming Plantago ovata origin - Swelling power: Not less than 9 mL/g for powder; not less than 40 mL/g for whole husk (per USP method) - Acid insoluble ash: Not more than 1.0% - Total ash: Not more than 4.0% - Microbial limits: Stricter than food grade — total aerobic count ≤ 10,000 CFU/g; E. coli absent in 10g; Salmonella absent in 25g - Heavy metals: Per USP <231> or <2232> limits
BP Monograph (British Pharmacopoeia)
The BP uses the name "Ispaghula Husk" (the official BP name for psyllium husk). Key specifications: - Swelling index: Not less than 40 mL/g - Foreign matter: Not more than 3.0% - Total ash: Not more than 5.0% - Complete microbial testing per BP 2.6.12
European Pharmacopoeia (Ph. Eur.) — "Ispaghula Husk"
The Ph. Eur. monograph 0858 for Ispaghula Husk is used by European pharmaceutical manufacturers including in Germany, France, Italy, Spain, Netherlands, and all EU member states. Key requirement: Swelling index ≥ 40.
What Documentation Do Pharma Buyers Need?
For pharma applications, suppliers must provide: (1) Batch-specific COA showing pharmacopoeial compliance with all test results (2) GMP certificate or ISO 22000 certification (3) Reference to specific pharmacopoeia tested against (4) Microbial testing per pharmacopoeial limits (5) Heavy metals per pharmacopoeial specifications (6) Residual solvents declaration (if applicable) (7) TSE/BSE statement (confirming no animal-derived materials)
Amar Herbal Origins supplies pharma-grade psyllium husk tested against USP, BP, and Ph. Eur. specifications. Our COA includes all pharmacopoeial test parameters with test methods cited. Full pharma-grade documentation package provided on request.
Amar Herbal Origins — Gujarat's trusted psyllium husk exporter. Get pricing, samples, and full COA documentation within 24 hours.