Analytical Chemistry
We will provide our valued customers with analytical chemistry research and quality control services for NCEs throughout their life cycle from the early clinical stage to commercial manufacturing.
Analytical Method Development and Validation
Guided by Quality by Design (QbD), we provide comprehensive analytical method development and validation in accordance with ICH Q2 based on Critical Quality Attributes (CQA) to support oral dosage form development. We also perform life cycle management to ensure quality research and control and provide accurate and reliable data at different drug development stages.
In addition to routine analysis, we support in vitro dissolution method development for insoluble compounds, e.g. amorphous solid dispersion, by understanding the fundamentals of dissolution mechanism and providing in vitro dissolution data to build the IVIVC research. We also provide genotoxic impurities, elemental impurities, and microbial limit testing services.
Forced degradation study
Stability indicating assay and related substance method
Content uniformity
Residual solvents
Genotoxic impurity
Method Validation according to ICH Q2
Novel analytical methods to enable formulation screening and optimization
In-vitro dissolution characterization to support formulation development and commercialization
Product Release
Crystal Pharmatech provides analytical services by strictly following the cGMP regulations of NMPA, FDA, and EMA, as well as Technical and Quality Agreement (TQA) with our customers. We test and release drug products according to these quality standards to meet the regulatory requirements of countries and regions where clinical supplies and commercial products are distributed.
Assay, identification, and related substance
Dissolution
Content uniformity
Water content
Elemental impurities
Residual solvent
Microbial limit test (MLT)
Stability Study
Stabilities studies, regardless of preformulation, early, or late stage developments, are critical for formulation development. CFS provide stability services at each development stage, including protocol design and testing of accelerated stability studies for perform and prototype development, probe and IND stability for RED at early development stages, stability study at late stage, e.g. Product Characterization Study (PCS), Formal Stability Study (FSS), for packaging definition, stability of intermediates (e.g. Spray Dried Intermediates, SDI), the hold-time stability of the drug products in production, in-use stability testing, stability of storage conditions and photostability testing based on ICH Q1A/Q1B, reevaluation of stability beyond the expiry date, and stability study of drug products after commercial launch etc. These stability data provide strong evidence for packaging selection, expiration date set, and lifecycle stability evaluation of drug products.
Probe and IND stability study for clinical supplies
Primary, registration, and formal stability study (FSS)
Product characterization study for packaging definition (PCS)
In-use stability
Photostability
Hold time stability
Time out of storage (TOS) and re-evaluation date (RED)
Cover all ICH conditions and specific conditions
Compatibility Study
Excipients play an important role in drug release, drug stability and manufacture of drug products. Crystal Pharmatech helps customers select the appropriate excipients in early formulation development through our comprehensive understanding of molecule and material properties. Analytical science supports formulation composition design by investigating the interactions between API and excipients.
We also provide compatibility study between packaging components and drug products, helping our customers choose appropriate packaging materials and evaluate the risk through well-designed extractable and leachable studies.
API-Excipient-Packaging Release
Crystal Pharmatech provides release testing service for API, excipients and packaging components according to the regulatory and GMP requirement at different development stages, ensuring product quality and safety by controlling from the original source.
These compatibility studies in pharmaceuticals. In a compatibility study, it is essential to assess how different components within a pharmaceutical product interact with each other. For instance, when conducting an excipient compatibility study, we need to examine how excipients, which are non - active ingredients used in drug formulations, interact with the active pharmaceutical ingredient (API).
We start by carefully selecting a variety of excipients commonly used in the industry. Then, we expose them to the API under different conditions such as varying temperatures, humidity levels, and light exposure. By monitoring the physical and chemical changes of the mixture over time, we can determine the stability and compatibility of the combination.
In the case of a full - scale compatibility study in pharmaceuticals, it involves not only the API - excipient relationship but also the interaction between the drug product and its packaging materials. This comprehensive approach helps to identify any potential issues that could affect the quality, efficacy, and safety of the pharmaceutical product.
For example, if a particular excipient causes the API to degrade or if the packaging material leaches harmful substances into the drug, it can lead to significant problems. Through well - designed compatibility study , we can make informed decisions about the selection of excipients and packaging materials, ultimately ensuring the long - term stability and quality of the pharmaceutical product.
If you want to know more about drug and excipient compatibility study in preformulation , please visit our website.
Crystal Pharmatech, founded in 2010, is a global contract research organization with approximately 300 employees and four R&D centers in New Jersey (USA), San Francisco (USA), Toronto (Canada), and Suzhou (China). Collectively, these sites provide integrated support for pharmaceutical and biotechnology companies worldwide. Crystal Pharmatech is a leading pharmaceutical CDMO/CRO company specializing in solid-state research and advanced formulation development for small molecule drugs.
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