Pharmaceutical Stability Analysis Service

Introduction Service Workflow Featured Services Stability Studies Types Tailor Solutions FAQs Resources Related Sections

Drug stability studies are an important part of the drug development and life cycle, especially in support of development and IND submission activities. The stability test assesses how the quality of the drug substance or drug product or its packaging changes over time under the influence of environmental factors including temperature, humidity and light. This process determines if any physical, chemical or microbiological changes affect the efficiency and integrity of the final products. These studies also help determine the optimal storage conditions, product quality and expiration date of the finished drug.

With a stable team providing a professionally managed Good Manufacturing Practice (cGMP) stability program, Creative Biolabs offers a wide range of capacities and conditions, including climate walk-in rooms, cabinets and refrigerators, and frozen storage. Even the most complex dosage forms, APIs or product types, including Oral Inhalation and Nasal Drug Products (OINDP), biopharmaceuticals or vaccines, are guaranteed to provide responsive and customized stability emergency and disaster recovery storage services to help you reduce the risks associated with expensive stability testing.

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Workflow of Stability Testing Services

Our stability testing process is highly structured and quality-driven:

Fig.1 Workflow of Stability Testing. (Creative Biolabs Original) Fig.1 Stability Testing Workflow.

Sample Receipt and Documentation
Upon receipt, all samples undergo detailed verification and condition checks. This includes logging batch details and ensuring that storage parameters are met.
Customized Protocol Development
Tailored testing protocols are designed based on ICH guidelines and specific product requirements, addressing unique attributes like biologic formulations.
Controlled Storage Conditions
Samples are placed in climate-controlled chambers adhering to predefined conditions (e.g., ICH Q1A and Q1B). Storage facilities are equipped with continuous monitoring and backup power systems to prevent data loss.
Periodic Testing and Analysis
Stability samples undergo scheduled analyses to measure impurity profiles, degradation products, and physical changes using advanced techniques like HPLC and UPLC.
Data Interpretation and Reporting
Stability data is analyzed and compiled into comprehensive reports that align with regulatory submission standards, ensuring seamless integration into IND, NDA, or ANDA filings.

Novel and Specialized Services

In-Use Stability Testing

Evaluates how drugs maintain their stability during use, such as after reconstitution or repeated openings, ensuring product efficacy until the end of its intended use period.

Biologics Stability Testing

Our biologics stability testing addresses the unique challenges of protein-based therapies, such as aggregation and oxidation. Techniques like dynamic light scattering are employed to ensure structural integrity.

Stress Studies for Advanced Formulations

Specialized testing is available for modern drug delivery systems, such as lipid nanoparticles (LNPs) and mRNA-based therapeutics. These studies assess formulation stability under storage and transportation conditions.

Comprehensive Types of Stability Studies

Accelerated Stability Studies

These studies simulate extreme conditions to predict long-term stability. For example, high-temperature and high-humidity environments help assess potential degradation pathways for APIs and formulations. These insights are crucial for optimizing manufacturing and storage conditions.

Intermediate Stability Studies

Intermediate studies bridge accelerated and long-term testing, examining drug performance under moderate conditions. They are particularly valuable for understanding degradation trends in temperate climates.

Long-Term Stability Studies

Conducted under real-world storage conditions, long-term stability studies establish precise shelf-life predictions. These studies are critical for supporting regulatory submissions such as NDAs and ANDAs.

Forced Degradation Studies

Forced degradation studies expose drugs to extreme stressors like pH variation, oxidation, and thermal conditions to uncover degradation mechanisms and validate stability-indicating methods.

Drug-Excipient Compatibility Studies

Evaluating the interaction between active pharmaceutical ingredients (APIs) and excipients ensures that the formulation remains stable and effective.

Impact of Manufacturing Steps

Our stability studies assess how manufacturing processes, such as freeze-drying or sterilization, impact the overall stability of the drug product.

Packaging Interactions

Investigations into the compatibility of packaging materials help safeguard product integrity during storage and distribution.

Tailor Solutions to Your Molecule Types

Molecule Type	Technique	Applications	Example	Why Choose This Technique?
Small Molecule Impurities	High-Performance Liquid Chromatography (HPLC)	- Impurity profiling for regulatory submissions. - Stability-indicating method validation.	Detecting degradation products in paracetamol under accelerated conditions.	- High resolution and precision. - Accurate quantification of low-concentration impurities.
Protein Aggregation	Dynamic Light Scattering (DLS)	- Evaluating stability of biologics under stress. - Quality assurance for therapeutic antibodies.	Detecting aggregation in IgG formulations after freeze-thaw cycles.	- Non-invasive and highly sensitive to particle size changes. - Ideal for early detection of aggregation.
Structural Integrity of Proteins	Circular Dichroism (CD) Spectroscopy	- Stability studies for biologics during formulation development. - Quality assurance for protein-based therapies.	Monitoring secondary structure of vaccines like recombinant antigens during storage.	- Provides rapid insights into secondary structure changes. - Real-time monitoring of protein integrity.
Impurities in Complex Mixtures	Mass Spectrometry (MS)	- Identifying impurities in advanced delivery systems. - Characterizing degradation products in complex formulations.	Detecting oxidative degradation in lipid nanoparticle-based RNA vaccines.	- High sensitivity and specificity. - Capable of identifying unknown degradation pathways.
Thermal Stability	Differential Scanning Calorimetry (DSC)	- Optimizing storage conditions for biologics. - Comparing thermal profiles of innovator drugs and biosimilars.	Measuring melting temperatures of monoclonal antibodies in biosimilar formulations.	- Provides direct insights into thermal denaturation. - Essential for formulation development and comparison.
Physical Changes in Solid Forms	Raman Spectroscopy	- Monitoring physical stability of solid oral formulations. - Detecting polymorphic impurities in APIs.	Assessing crystallinity changes in atorvastatin tablets during storage.	- Non-destructive with minimal sample preparation. - High specificity for solid-state characterization.
Photostability	UV-Vis Spectroscopy	- Ensuring stability under ICH Q1B photostability conditions. - Verifying light-protective packaging efficacy.	Analyzing photodegradation in light-sensitive drugs like nifedipine.	- Quick and cost-effective analysis. - Highly adaptable for routine photostability testing.
Water Content	Karl Fischer Titration	- Ensuring moisture stability in APIs and formulations. - Validating desiccant efficacy in packaging.	Determining water content in dry powder inhalers.	- Highly accurate for low water content analysis. - Essential for moisture-sensitive products.
Nanoparticle Stability	Nanoparticle Tracking Analysis (NTA)	- Stability assessment for lipid nanoparticles (LNPs). - Monitoring nanoparticle aggregation under stress conditions.	Tracking particle size of siRNA delivery vehicles during storage.	- Real-time monitoring of particle size changes. - High-resolution tracking of sub-micron particles.
Packaging Compatibility	Gas Chromatography (GC)	- Ensuring safety and compatibility of packaging materials. - Analyzing leachables in pharmaceutical containers.	Detecting volatile organic compounds in blister packs for oral solid dosage forms.	- High sensitivity for volatile compounds. - Accurate quantification of leachables and residual solvents.
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To help you meet the quality, safety and regulatory standards you expect from drugs, our common tests cover impurity analysis, dissolution, moisture, hardness, friability and disintegration to ensure complete products and packaging systems show sufficient stability throughout the product lifecycle.

Based on the expertise of OINDP testing and the extensive stability studies experience, Creative Biolabs' scientists provide the development and validation of stability study methods through state-of-the-art technology in our stability analytical laboratories. With a comprehensive understanding of the latest developments in regional, national and ICH stability research guidelines, we aim at providing truly flexible and stable outsourcing partnerships, integrated storage and testing capabilities that allow you to focus on your core business objectives, bringing quality and safety to manufacture.

To find out more about our lot release testing services, please contact us.

FAQs

What specialized tests are available for biologics?

Techniques like CD spectroscopy and dynamic light scattering are tailored to address the aggregation and structural stability of biologics.

What are the key ICH guidelines for stability testing?

The ICH Q1A-Q1F guidelines define best practices for storage conditions, test durations, and data evaluation, ensuring global harmonization in stability testing.

Can you test OINDPs (oral inhalation and nasal drug products)?

Yes, our stability testing includes specialized protocols for oral inhalation and nasal drug products, ensuring compliance with strict regulatory requirements.

What is forced degradation testing?

Forced degradation testing identifies degradation pathways by exposing drugs to extreme stressors like heat, light, and oxidation, validating stability-indicating methods.