What are Multi-Compendial Excipients?
Multi-compendial excipients are pharma-grade ingredients that comply with the standards of two or more major pharmacopoeias, such as:
Contents
- USP, NF (United States Pharmacopeia–National Formulary)
- Ph. Eur. (European Pharmacopoeia)
- JP (Japanese Pharmacopoeia)
- IP (Indian Pharmacopoeia)
- ChP (Chinese Pharmacopoeia)
These are ideal for global product registration, helping formulators simplify sourcing and documentation across regions.
Applications in Oral Formulations
Multi-compendial excipients are used in:
- Tablets & Capsules: Fillers, binders, disintegrants, lubricants
- Syrups & Suspensions: Sweeteners, thickeners, preservatives
- Granules & Powders: Flow agents, taste-masking agents
Example Excipients:
| Excipient | Function | Compendial Compliance |
|---|---|---|
| Microcrystalline Cellulose | Binder/Filler | USP / Ph. Eur. / JP |
| Lactose Monohydrate | Diluent | USP / Ph. Eur. / IP |
| Sodium Starch Glycolate | Superdisintegrant | USP / Ph. Eur. / JP |
Applications in Topical Formulations
Used in:
- Creams, Ointments & Gels: Emulsifiers, humectants, preservatives
- Dermal Sprays or Lotions: Solvents, film-formers, stabilizers
Example Excipients:
| Excipient | Function | Compendial Compliance |
|---|---|---|
| Propylene Glycol | Solvent/Humectant | USP / Ph. Eur. / JP |
| Carbomer | Gelling agent | USP / Ph. Eur. |
| Cetyl Alcohol | Emollient | USP / Ph. Eur. / JP |
Why Choose Multi-Compendial Excipients?
| Benefit | Description |
|---|---|
| 🌐 Global Regulatory Acceptance | Fewer barriers for multinational filing |
| 📄 Streamlined Documentation | Simplified Certificate of Analysis (COA) and DMF support |
| ⚖️ Batch Consistency | Reduced variability and cross-market rejection risk |
| 🚀 Faster Time-to-Market | Fewer reformulations or retesting across regions |
For pharmaceutical manufacturers targeting global markets, multi-compendial excipients are not just a regulatory convenience, they’re a strategic necessity. Whether formulating for oral solid dose or topical dermal applications, selecting the right grade ensures compliance, performance, and commercial success.
