Excipients
At SK Pharma Tech Solutions, we provide comprehensive excipient evaluation and support services that ensure the quality, safety, and performance of excipients used in pharmaceutical development and manufacturing. Whether you’re developing new formulations or validating raw materials, our scientific team delivers reliable data aligned with regulatory requirements and industry standards.
Excipients Service Overview
Excipients play a critical role in drug formulation — affecting stability, manufacturability, bioavailability, and overall product performance. Our excipient services help clients verify material suitability and ensure consistent performance throughout the product lifecycle.
Key Excipients Capabilities
Identity & Purity TestingIdentity & Purity Testing
- Confirm excipient identity using advanced analytical techniques
- Assay and purity evaluation against pharmacopeial standards (e.g., USP/EP)
- Detect and quantify impurities affecting functionality
Physicochemical Characterisation
- Particle size distribution
- Moisture content (e.g., water determination)
- pH, viscosity, and other critical physical attributes
Method Development & Validation
- Tailored analytical methods specific to excipient matrices
- Robust method validation for regulatory compliance
- Transfer-ready analytical protocols
Compatibility & Stability Studies
- Excipient-API compatibility testing
- Stability behavior under ICH conditions
- Forced degradation assessment
Elemental & Microbial Testing
- Elemental impurity evaluation (ICP/MS)
- Microbiological safety checks (where applicable)
- Contaminant profiling
Why Choose Our Excipients Services
- Deep analytical expertise across pharmaceutical raw materials
- State-of-the-art instrumentation for accurate, reproducible results
- Compliance with global guidelines and pharmacopeial requirements
- Customizable testing packages based on project needs
What are pharmaceutical excipients and why are they important?
Pharmaceutical excipients are inactive ingredients used in drug formulations to support the active pharmaceutical ingredient (API). They improve stability, solubility, bioavailability, manufacturability, and patient acceptability of the final product.
Why is excipient testing required in pharmaceutical manufacturing?
Excipient testing ensures identity, purity, quality, and consistency as per pharmacopeial standards such as USP, EP, IP, and BP. Proper testing prevents formulation failures, contamination risks, and regulatory non-compliance.
What types of tests are performed on excipients?
Common excipient tests include identity testing, assay and purity analysis, moisture content determination, particle size analysis, pH testing, microbial testing, elemental impurity analysis (ICP-MS), and stability studies.
Do you perform excipient and API compatibility studies?
Yes. We conduct excipient-API compatibility studies to detect potential chemical or physical interactions that may affect drug stability, safety, or performance during shelf life.
Are your excipient testing services compliant with regulatory guidelines?
Yes. All testing procedures follow international regulatory guidelines such as ICH, USP, EP, IP, and GMP standards to ensure regulatory acceptance and audit readiness.
Can you support excipient testing for regulatory submissions?
Yes. We provide detailed analytical reports, certificates of analysis (CoA), and validated data suitable for regulatory filings, quality audits, and documentation requirements.