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Product Testing Services

Ensuring Quality, Consistency, and Compliance Across the Product Lifecycle

Reliable analytical testing is essential to confirming product quality, batch-to-batch consistency, regulatory compliance, and real-world performance, especially for semi-solid and non-sterile liquid pharmaceuticals. CPL provides a fully integrated suite of GMP product testing services tailored to the complex requirements of topical drug products, including ointments, gels, suspensions, solutions, and nasal sprays. With FDA- and Health Canada-registered laboratories on-site, CPL delivers fast turnaround, consistent quality, and continuous analytical support from early development through commercial manufacturing.

Trusted GMP Product Testing for Semi-Solid and Non-Sterile Liquid Drug Products

CPL’s quality control and analytical laboratories perform a full range of release, stability, and performance testing required to support clinical batch manufacturing, registration campaign, process validation, tech transfer, and ongoing commercial supply. Our QC operation, supported by analytical chemists, microbiologists, stability specialists, and performance testing experts, ensures that every test method, specification, and data package aligns with global regulatory expectations.

Semi-Solid Drug Products

  • Assay and related substances
  • Content uniformity and homogeneity
  • Viscosity, rheology, and texture analysis
  • Microstructure and particle-size evaluation
  • Preservative effectiveness
  • Microbiological testing
  • IVRT/IVPT performance data integration
  • Ongoing in-use and storage stability

Non-Sterile Liquid Drug Products

  • Assay, impurity, and degradant profiling
  • Zeta potential for suspensions
  • pH, viscosity, density, appearance
  • Preservative and microbial control testing
  • Nasal spray pump performance
  • Dose delivery and uniformity
  • Container closure system integrity testing
  • Stability studies aligned with ICH guidelines

Optimized Analytical Method Meets Validation Requirements

During validation of a client-supplied assay method for a cream product, key parameters—including accuracy, recovery, repeatability, and intermediate precision—failed to meet acceptance criteria. Assay results consistently exceeded 100%, especially for lower-strength samples, raising concerns about method reliability.

Product Testing Capabilities At-a-Glance

GMP release testing for semi-solids & liquids

Comprehensive compendial methods

Stability testing & storage services (ICH)

Degradation profiling

Elemental impurities testing

Residual solvents testing

Water determination

Dissolution testing

Microbiology & preservative efficacy testing

Viscosity testing

Particle size and globule size analysis

Container-closure system verification

IVRT (in vitro release testing)

IVPT (in vitro permeation testing)

Supporting Technologies & Facilities

40,000 ft2 laboratory space with state-of-the art analytical instrumentation

HPLCs (high-performance liquid chromatography)

UPLCs (ultra-performance liquid chromatography)

GCs (gas chromatography)

Dissolution apparatus

ICP-MS (inductively coupled plasma mass spectrometry)

Viscometers

Rheometers

pH meters

Osmometers

Refractive Index

ELSD (evaporative light scattering detector)

Microscopes

Malvern 3000 Laser Diffraction

Sympatec Halo particle analyzer

Melting point apparatus

KF titrators

Water activity meter

Auto titrators

Dedicated to Excellence
from Molecule to Commercialization

CPL supports programs from early-phase through commercial launch, combining preformulation insight, robust semi-solid and non-sterile liquid development, scalable process design, and clinical and commercial manufacturing.

Pharmaceutical Development Services Icon

Pharmaceutical Development Services

Analytical & Product Testing Icon

Analytical & Product Testing

Clinical & Commercial Manufacturing Icon

Clinical & Commercial Manufacturing

Packaging, Labeling & Serialization Icon

Packaging, Labeling & Serialization

Semi-Solid & Non-Sterile Liquid Expertise Icon

Semi-Solid & Non-Sterile Liquid Expertise

Unique Product Handling Experience Icon

Unique Product Handling Experience

Concept to Commercial Capabilities Icon

Concept to Commercial Capabilities

Regulatory Classification-Specific Strategies Icon

Regulatory Classification-Specific Strategies

FAQs

Explore answers to the most frequently asked product testing questions.
  • CPL offers comprehensive product testing for semi-solid and non-sterile liquid formulations, including release testing, stability testing, degradation profiling, elemental impurities testing, residual solvents testing, water determination, dissolution testing, microbiology, preservative efficacy testing, and more. We support topical products such as ointments, creams, gels, lotions, and non-sterile liquid formulations, including suspensions, solutions, and nasal sprays, ensuring compliance with leading pharmacopeias and ICH requirements.

  • For semi-solid dosage form manufacturing, CPL provides in vitro release testing (IVRT) per USP <1724> and in vitro permeation testing (IVPT) using Franz diffusion cells. These studies characterize drug release, skin absorption, and dermal penetration, support topical formulation development, and help address topical drug bioequivalence requirements, especially for generic and OTC development and manufacturing programs.

  • CPL runs ICH-aligned stability programs (long-term, intermediate, and accelerated) for semi-solids and non-sterile liquids, monitoring CQAs such as potency, degradation products, viscosity, pH, and microbiological quality. We also evaluate container closure systems for tubes, bottles, foil sachets, and nasal spray devices, looking at compatibility, closure integrity, and in-use performance to support product quality and regulatory submissions.

  • CPL integrates analytical development services, analytical method validation, and product testing to fully support clinical batch manufacturing, registration batch manufacturing, and commercial manufacturing pharma programs. Our validated methods and GMP testing underpin scale-up, technology transfer, and ongoing pharmaceutical process validation, reducing batch failures, ensuring consistent product performance, and providing robust data packages for Health Canada, FDA, EMA, and other leading regulators.

Commitment.
Partnership. Legacy.

Leverage CPL’s 35 years of expertise in non-sterile liquids and semi-solids to ensure your program's success. We’ll support your product from molecule to market, or step in at any stage of its product lifecycle.

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