WE ARE COMMITTED
to providing our clients in-depth and expedient methodology to ensure quality of their API and drug products

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.

WE ARE COMMITTED