| CoreRx™ formulation development and clinical manufacturing efforts are fully supported by our in-house analytical development laboratories. Equipped with state of the art analytical instruments, CoreRx™ analytical development provides services in support of pre-formulation, formulation, drug product performance testing, and clinical release testing for oral delivery (tablets, capsules, orally disintegrating tablets (ODT), and softgels), parenteral, ophthalmic, topical, and novel dosage forms for small molecules. Fully compliant with cGMP/GLPs, CoreRx™ can help you through NDA & ANDA submissions.
 Representative Analytical Development Services
 Preformulation
Salt Selection & Polymorph Screening
Compatibility Studies
Method Transfer & Evaluation
Method Optimization
Method Development
Phase 1-3 Level Method Validation
Product Analysis (physical & chemical)
Stability Studies
ICH Storage
Impurity Identification
Preformulation Analysis
Characterization of the API (Active Pharmaceutical Ingredient) is critical to designing a formulation approach. A variety of tests and services are offered to help characterize and select the final drug candidate.
Particle Size
Solubility Profile
Partition Coefficient
Thermal Analysis
Hygroscopicity
Chemical & Physical Stability Evaluation
Polymorphism |
Impurity Identification
Drug Potency
Impurity Assay Development / Validation
Methods Transfer
Method Evaluation / Optimization
Salt Selection |
Method Development
CoreRx™ provides complete method development for both drug substance (API) and formulated drug product. With expertise in solids, semi-solids, syrups, suspensions, parenterals, ophthalmic, and topical, the CoreRx™ analytical team has successfully developed methods for hundreds of compounds. Additionally, CoreRx™ can support high potent compounds (cytotoxic), and DEA schedule II-V compounds (controlled drugs).
Validation Expertise
CoreRx™ can support drug product and drug substance methods validation. As a FDA registered lab, CoreRx™ can validate methods developed at CoreRx™, as well as client or third party methods. Full validation criteria may include the following.
Validation Criteria
Specificity (forced degradation)
Accuracy and Precision
Linearity and Range
LOD/LOQ |
Ruggedness
Robustness
Solution Stability
Related Substances Identification (Impurities) |
Abbreviated validation studies can be executed for drug formulations that are in early stages of development, when a potential for formulation change/optimization in Phase II or III may exist.
Analytical Techniques and Project Support
Using a variety of analytical techniques is critical to getting the best formulation for your compound. CoreRx™ offers a complete range of analytical techniques and project support analysis to accomplish your unique goals.
Techniques
High Performance Liquid Chromatography (HPLC)
Gas Chromatography (GC)
Liquid Chromatography/Mass Spectrometry (LC/MS)
Dissolution (Apparatus I-III)
Thin Layer Chromatography (TLC)
Moisture by Karl Fisher
Physical testing (friability, hardness)
Osmolality
Viscosity
Particle Size Analysis
Project Support
Drug Product Formulation Screening
Semi-Preparative Purifications
Assay And Impurity Development & Analysis
ICH Stability Storage
Stability Testing
Compatibility Studies (Drug-Drug, Drug-Package, Drug Excipient)
De-Formulation
Drug Substance & Drug Product Analysis
Cleaning Validation
Degradation & Photo-Stability Studies
ICH Stability Storage
Our facilities offer a range of storage options for your products.
Reach-In Chambers
5°C
25°C/40% RH
30°C/65% RH
40°C/75% RH |
cGMP Storage Refrigerators
-20°C
-50°C
-80°C
2-8°C |
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