Analytical and Stability

Drug product development and clinical manufacturing efforts at CoreRx are fully supported by our cGMP compliant in-house analytical laboratories. Equipped with state of the art analytical instruments, CoreRx provides analytical method support, release and stability testing services for a variety of dosage forms including oral, parenteral, ophthalmic, suppository, and topical routes of delivery.

Method Development and Validation 

CoreRx provides method development, optimization, transfer, and phase appropriate qualification/validation services for a variety of dosage forms. Our services includes methods for:

Stability indicating assay and/or related substances methods, including blend uniformity and content uniformity evaluation

  •  HPLC & UPLC systems available for reverse phase, ion exchange or size exclusion methods.
  • Detection technologies include: UV, PDA, ELSD, Fluorescence, CAD, RI and Conductivity

Single point, multi-point, and 2-stage dissolution methods

  • Apparatus 1-III
  • Micro dissolution baths available for R&D

Organic impurities methods using gas chromatography (GC)

Cleaning methods for support of cGMP manufacturing

Preformulation and Formulation Support Services

Characterization of the Active Pharmaceutical Ingredient (API) is critical to designing a successful formulation approach. When properties are correctly evaluated in the pre-formulation stage, potential downstream formulation and stability problems are minimized.  For this reason, our analytical department works hand in hand with our formulators at the earliest point in the drug development process, bringing unmatched expertise throughout formulation development process leading to final prototype selections.

Our Testing and Support Services include:

  • Particle Size Analysis
  • pH/Stability/Solubility Profiles
  • Partition Coefficient
  • Thermal Analysis
  • Hygroscopicity
  • Excipient Compatibility Testing
  • Polymorphism Screening
  • Drug Potency Analysis
  • Chemical & Physical Stability Evaluation
  • Physical characteristic analysis for solid, liquid and semi-solid prototypes
  • Product uniformity evaluation
  • In-vitro release & permeability testing/characterization (dissolution & franz cell)
  • Photostability studies
  • Temperature cycling and freeze-thaw studies
  • Material/Packaging Compatibility Testing

Drug Product Release & ICH Stability Services

CoreRx offers comprehensive drug product release & stability services as either stand-alone projects, or in support of full development and manufacturing programs conducted at CoreRx. Whether your product is in development or already on the market, CoreRx can fulfill your release and stability storage/testing requirements for a variety of dosage forms including oral, topical, parenteral, suppository and ophthalmic products.

Our QC Services include:

  • Release testing
  • Stability protocol generation
  • Stability storage
  • Stability testing
  • Stability summary report generation
  • Stability time points and conditions specific report generation

cGMP Stability Chambers

We offer ICH walk-in chambers as well as custom condition reach-in chambers, with 24/7 monitoring, back-up power and comprehensive disaster recovery plans.

Walk-In Chambers

  • 5°C
  • 25°C/60% RH
  • 30°C/65% RH
  • 40°C/75% RH

Reach-In Chambers

  • Three Custom Condition Chambers
  • Darwin Freeze/Thaw Chamber

cGMP Storage Refrigerators

  • Revco Ultima -20°C
  • Revco Ultima -50°C
  • Revco -80°C
  • Warehouse Refrigerator for QA Retains Storage 2-8°C

Partner with us

When you’re ready to get expertise, flexibility, and reliability with your pharmaceutical formulation project, call us or fill out this form. We’ll be happy to answer your questions, provide a tour of our facilities, and get your project started today.