Pharmaceutical-Grade Bromelain for Supplement and Nutraceutical Production
High-purity bromelain for nutraceutical, wound care and supplement manufacturing — standardised by GDU/g with full pharmaceutical documentation.
Bromelain is one of the most widely studied plant-derived proteolytic enzymes used in pharmaceutical and nutraceutical manufacturing. We supply pharmaceutical-grade bromelain as a raw material to formulators. The finished-product application, any claims made about it, its dosage and its regulatory classification are determined by the manufacturer, not by us. Material is supplied against a Certificate of Analysis for the specific lot, with full documentation for incoming-goods qualification.
Supplement and Nutraceutical Formulation
Bromelain powder is used as a raw material in capsule and tablet supplement manufacturing. Dosage, product claims and regulatory classification are set by the formulator. The specifications that most affect processing are particle size distribution, bulk density and moisture content. Enteric coating is commonly specified where gastric protection of the enzyme is required. Material is standardised on activity and supplied with a Certificate of Analysis stating the value for the lot.
Wound Care and Topical Formulation R&D
Bromelain is used as a raw material in wound care and topical formulation research. Material for this application typically requires high specific activity, controlled particle size for gel formulation, and full microbial safety testing. Finished-product development, clinical validation and regulatory approval are the responsibility of the formulator.
Digestive Enzyme Supplement Blends
Bromelain at 100–500 mg per capsule (600–2,400 GDU/g) is commonly included in broad-spectrum digestive enzyme supplements alongside protease, amylase, lipase, and cellulase. For this application, pharmaceutical-grade purity with low microbial count and heavy metal absence is required for US NSF-certified or EU GMP-compliant supplement production. Stability data in capsule matrices and compatibility with co-formulated enzymes should be verified.
Respiratory and Liquid-Format Supplement Products
For liquid and syrup format supplements, water-soluble bromelain with confirmed stability at pH 5.0-7.0 is preferred. Dosage and product claims are determined by the formulator. Our pharmaceutical-grade bromelain dissolves readily and is supplied with solubility and stability data for the specific lot.
| Parameter | Value |
| Activity range | 600 – 2,400 GDU/g (or 1,000,000 CDU/g) |
| Optimal pH | 5.0 – 8.0 |
| Optimal temperature | 40°C – 65°C |
| Form | Light yellow powder — pharmaceutical grade |
| Shelf life | 24 months (sealed, cool, dry place) |
| Packaging | 25 kg drums / 1 kg / 5 kg bags for pharma |
Frequently Asked Questions
What is the difference between GDU/g and CDU/g in bromelain activity specification?
GDU (gelatin digestion units) measures bromelain activity using gelatin as substrate under standardised conditions defined by the FCC (Food Chemicals Codex). CDU (casein digestion units) uses casein as substrate, which provides higher sensitivity for protease activity. The two units are not directly interchangeable due to different substrate specificities. A typical pharmaceutical-grade bromelain at 2,400 GDU/g is approximately equivalent to 1,000,000 CDU/g. Always specify which unit system your quality standard uses to ensure comparable activity between batches.
What documentation is provided for pharmaceutical and nutraceutical procurement?
Our pharmaceutical-grade bromelain documentation includes: COA with GDU/g activity, specific activity ratio, protein content, moisture, and pH; TDS covering stability, solubility, and formulation guidance; MSDS; ISO 9001 certificate; HALAL and KOSHER certificates; heavy metal testing (Pb, Cd, As, Hg per USP/EP limits); total aerobic plate count and pathogen absence; and country-of-origin documentation. For US supplement manufacturers, NSF-compatible quality data is available. For EU, full traceability to raw material source can be provided.
Is bromelain stable in capsule and tablet formulations?
Bromelain in dry powder form in capsules or tablets (without moisture) is generally stable for 24 months at room temperature (below 25°C) when stored sealed and away from light and humidity. It should not be co-formulated with strong oxidants, reducing agents, or heavy metals that could denature the cysteine active site. Compatibility with specific excipients (fillers, binders, coating polymers) should be confirmed through accelerated stability studies at 40°C/75% RH following ICH Q1A guidelines for supplement stability.
Can bromelain be used in enteric-coated products for systemic absorption?
Enteric coating is commonly used for bromelain products targeting systemic proteolytic activity, because uncoated bromelain may be partially inactivated by gastric acid at pH below 3.0 before reaching the small intestine where absorption occurs. Standard enteric coating with Eudragit L100-55 or HPMC phthalate provides gastric protection and releases the enzyme at pH 5.5 in the duodenum. Bromelain enteric pellets or enteric-coated tablets are established pharmaceutical formats in German enzyme combination products.
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