Quality Control

CCrest Laboratories performs scientific services under Health Canada cGMP Drug Establishment License.

Does your Pharmaceutical Quality strategy fully ensure the regulatory requirements of your therapeutic products throughout their lifecycle?

Starting early in the drug development process and continuing through clinical trials and commercialization, we support you from discovery to market.


CCrest presents an extensive suite of services including standalone analytical R&D, method validation, release testing, ICH stability, and routine QC testing.

Our team of analysts meticulously reviews every process to guarantee that procedures, outcomes, and paperwork meet and exceed the exacting quality requirements to satisfy internal controls and regulatory submissions.

You require comprehensive pipeline support and personalized services:

Our laboratories and skilled workforce are perfectly prepared to satisfy your analytical testing needs and ensure that your products conform to the strictest safety and quality criteria.

Discover more about our range of analytical testing competencies and services below.

Analytical Chemistry

CCrest excels in thorough and efficient analytical testing, safeguarding the integrity and compliance of your pharmaceutical products.

Physical and Physicochemical Characterization

Our suite of physical and physicochemical characterization services, encompassing particle size analysis, viscosity profiling, density measurements, and more, is integral for an in-depth understanding of a substance's physical attributes and behaviors.

Analysis of Key Physical Parameters

We conduct comprehensive analyses of essential physical parameters such as melting points, boiling points, refractive indices, and electrical conductivity. This analysis is pivotal for a thorough understanding of material performance and characteristics.

Wet Chemistry Analytical Techniques

Our wet chemistry analytical services offer detailed qualitative and quantitative insights, essential for elucidating the chemical composition, reactions, and properties of substances. We utilize a spectrum of wet chemistry methodologies for precise substance characterization and identification.

Compound Identification and Characterization

Utilizing advanced spectroscopic and chromatographic techniques, our compound identification and characterization services accurately ascertain the composition and purity of compounds. This service is vital for verifying the identity of substances and detecting impurities.

Quantitative Assay and Content Analysis

We provide precise quantitative assay and content analysis to measure active ingredients, in alignment with regulatory compliance. Our methods, conforming to industry standards, offer reliable evaluations of a substance's potency and purity.

Residual Solvents Quantification

We implement sophisticated analytical techniques for the quantification and detection of residual solvents in products, ensuring conformity with safety regulations and quality standards. This analysis is essential for mitigating risks and enhancing consumer safety.

Impurities and Related Substances Analysis

Our extensive capabilities in analyzing impurities and related substances enable the identification and quantification of these elements in various samples. This service provides clients with essential insights into the purity and composition of their products

Dissolution Rate Testing Services

Our dissolution rate testing is designed to evaluate the release rate of active ingredients from solid dosage forms, a key factor in assessing their efficacy and bioavailability. This service yields critical data for formulation refinement and quality assurance.

Trust us to be your partner in maintaining the highest standards of pharmaceutical quality control.

Microbiology Testing

Our microbiology testing services are integral to ensuring the pharmaceutical quality and safety of products. Our expert team employs the latest techniques and adheres to strict regulatory guidelines, providing reliable and accurate results.

Microbiological Analysis

Our routine microbiological testing is a cornerstone of pharmaceutical quality control. We conduct comprehensive analyses to detect, identify, and quantify microbial contaminants in pharmaceutical products. This includes testing for bacteria, fungi, yeasts, and other microorganisms, ensuring that products meet the stringent safety standards required in the pharmaceutical industry.

Sterility Testing

Sterility testing is a critical component of our microbiological services. We employ advanced methods to ensure that pharmaceutical products, particularly injectables and sterile preparations, are free from viable microorganisms. Our rigorous testing protocols are designed to comply with international pharmacopeial standards, providing clients with the assurance of product safety.

Endotoxin and Pyrogen Testing

We specialize in endotoxin and pyrogen testing to detect the presence of harmful bacterial endotoxins in pharmaceutical products. This testing is crucial for products intended for parenteral administration, as endotoxins can induce fever and other adverse reactions in patients. Our state-of-the-art testing methods ensure that products are safe for human use.

Antimicrobial Effectiveness Testing

Our laboratory also conducts antimicrobial effectiveness testing to evaluate the efficacy of preservatives in pharmaceutical formulations. This testing is essential to ensure that preservatives are adequately inhibiting microbial growth over the product's intended shelf life, maintaining its safety and efficacy.

Environmental Monitoring and Control

In addition to product testing, we offer environmental monitoring services to ensure that the manufacturing and processing environments meet the required microbiological quality standards. This includes air and surface monitoring, personnel monitoring, and water system testing, all of which are crucial for maintaining a contamination-free production environment.

Stability Studies

Our stability studies are supported by rigorous analytical testing to ensure accuracy and reliability. We provide comprehensive data and detailed reporting, supporting regulatory submissions and adherence to international standards.

Regular Stability Studies

Our regular stability studies are integral to assessing the long-term consistency of pharmaceutical products. Conducted under standard storage conditions, these studies provide valuable insights into the product's stability over its intended shelf life, ensuring quality and efficacy.

Intermediate Stability Testing

Our intermediate stability testing pushes the boundaries beyond regular studies, exposing products to more challenging conditions. This approach is essential for predicting how a product might behave under unexpected storage scenarios, providing an additional layer of assurance in product stability.

Accelerated Stability Testing

To swiftly predict a product's shelf life, we employ accelerated stability testing. This method involves subjecting the product to elevated temperature and humidity levels, offering early indicators of its stability profile. Such testing is valuable for rapid assessment and timely decision-making in product development.

ICH Climatic Zone Testing

Understanding the global reach of pharmaceutical products, we conduct stability studies across various ICH climatic zones. This ensures that products maintain their stability and effectiveness, regardless of geographical and environmental variations, catering to a global market.

In-Use Stability Testing

Specializing in in-use stability testing, CCrest Laboratories evaluates the stability of products post-opening and during use. This is particularly vital for multi-dose formulations, where stability can be affected once the packaging is opened. Our testing ensures the product remains stable and effective throughout its usage period.