Compendial Monographs Testing
RMA provides comprehensive raw materials and finished product testing in accordance with recognized compendial monographs, supporting pharmaceutical, biopharmaceutical, and related regulated industries. Our testing services are designed to ensure materials and products meet established pharmacopeial requirements, regulatory expectations, and internal quality standards throughout the product lifecycle.
Compendial monographs define standardized test methods, acceptance criteria, and specifications to verify the identity, strength, quality, and purity of materials and finished dosage forms. RMA performs monograph-driven testing in alignment with applicable pharmacopeias, delivering accurate, defensible data supported by robust quality systems.
Pharmacopeial Standards We Support
RMA offers testing aligned with major global pharmacopeias, including but not limited to:
- United States Pharmacopeia (USP–NF)
- Below is the list of monographs we can support for USP-NF
- European Pharmacopoeia (EP)
- Below is the list of monographs we can support for EP
- Japanese Pharmacopoeia (JP)
Our laboratory capabilities support harmonized and non-harmonized methods, allowing clients to meet regional and global regulatory requirements.
Raw Materials Compendial Testing
We support compendial testing for a wide range of pharmaceutical raw materials, including active pharmaceutical ingredients (APIs), excipients, polymers, resins, and chemical components. Typical monograph testing includes:
- Identification (IR, UV, chromatographic techniques)
- Assay and content determination
- Impurities and related substances
- Physicochemical properties (pH, viscosity, refractive index, etc.)
- Loss on drying / water content
- Residue on ignition / sulfated ash
- Compendial appearance, color, and clarity tests
Our team works closely with clients to ensure appropriate monograph selection, method execution, and interpretation of results for material qualification and release.
Finished Product Compendial Testing
RMA also performs finished product testing in accordance with applicable monographs for drug products and related materials. Testing is conducted to support batch release, stability studies, and regulatory submissions. Services include:
- Assay and potency
- Content uniformity
- Dissolution or performance testing
- Impurity and degradation product analysis
- Appearance, color, and clarity
- Physicochemical and functional testing as defined by monographs
We ensure methods are executed as written in the compendium or appropriately verified where required, maintaining full traceability and compliance.
Quality and Compliance
All compendial testing at RMA is performed within a GMP-compliant quality system, emphasizing data integrity, traceability, and regulatory readiness. Our experienced analysts and quality professionals ensure results are reliable, reproducible, and suitable for submission to regulatory authorities.
Why Choose RMA for Compendial Testing?
- Expertise in raw materials and finished product testing
- Support for USP, EP, and JP and other standards
- GMP-compliant operations and documentation
- Scientifically sound, defensible analytical data
- Collaborative approach to client-specific testing needs
