Analytical Services
Analytical Services
About Analytical Services
PharmaPure specializes in ensuring the quality, safety, and regulatory compliance of pharmaceutical products through comprehensive stability testing, analytical method development, and research bioanalysis. Our ICH-compliant services help determine shelf life, optimize formulations, and support regulatory submissions, including IND, NDA, and ANDA filings. With state-of-the-art laboratories and expert teams, we deliver precise, reliable data to help your topical and transdermal drug formulations achieve market approval and commercial success.
Comprehensive Stability Testing Services
Our stability studies evaluate how temperature, humidity, light, and packaging affect drug products to determine shelf life, optimize formulation stability, support regulatory submissions, and ensure consistent quality.
Key Stability Testing Services
Long-Term & Accelerated Stability: Monitor product integrity and predict shelf life under ICH guidelines.
Stress Testing: Identify degradation pathways by exposing products to extreme conditions.
Photostability Testing: Assess stability under light exposure.
Freeze-Thaw Studies: Evaluate integrity after repeated freeze-thaw cycles, essential for sensitive formulations.
Advanced Stability Storage Capabilities
PharmaPure’s state-of-the-art stability chambers are fully qualified and monitored, offering
 ICH-compliant storage conditions: Â
- 25°C ± 2°C / 60% RH ± 5% RH (Long-term)
- 40°C ± 2°C / 75% RH ± 5% RH (Accelerated)
- 5°C ± 3°C, -20°C ± 5°C, -70°C ± 15°C (Cold storage)
Customized storage solutions for unique formulations  Â
Real-time monitoring and automated alerts for temperature excursions Â
Stability Testing
Ensuring Product Efficacy and Safety Over Its Lifecycle
At PharmaPure, we recognize that stability testing is crucial for demonstrating the shelf life, efficacy, and safety of pharmaceutical products. Our ICH-compliant stability programs ensure that your formulations maintain their physical, chemical, and microbiological integrity over time. This not only meets regulatory requirements but also supports successful product approvals.
Key Components of Analytical and Bioanalytical Method Development 
Custom Analytical Method Development  Â
- Development of analytical methods for drug identity, potency, and impurity quantification  Â
- Optimization of HPLC, LC-MS/MS, GC-MS, and other advanced analytical techniques  Â
- Assay development for dissolution, viscosity, pH, and rheological properties  Â
- Tailored method design for complex formulations, including creams, gels, foams, and transdermal patches  Â
Bioanalytical Method Development for Drug Absorption and Pharmacokinetics  Â
- Quantification of drug levels in biological matrices (plasma, tissue, skin layers, and mucosa)  Â
- Assessment of absorption, metabolism, and systemic distribution of topical drugs  Â
- Support for bioequivalence studies and 505(b)(2) regulatory pathways  Â
- Evaluation of penetration enhancers and formulation modifications for improved bioavailability  Â
Method Validation for Regulatory Compliance  Â
- ICH-compliant validation of analytical and bioanalytical methods  Â
- Validation parameters include accuracy, precision, linearity, robustness, and specificity  Â
- Batch-to-batch reproducibility and process control validation  Â
- Comprehensive validation reports supporting IND, NDA, ANDA, and global filings  Â
Impurity Profiling and Stability Testing  Â
- Identification and quantification of degradation products and residual solvents  Â
- Forced degradation studies to assess formulation robustness  Â
- ICH Q1A-compliant stability testing for product shelf-life determination  Â
- Extractables and leachables testing to ensure formulation safety  Â
Regulatory-Driven Data Integrity and Compliance  Â
- GMP and GLP-compliant method development and validation  Â
- CMC (Chemistry, Manufacturing & Controls) documentation preparation  Â
- Data integrity compliance with FDA 21 CFR Part 11 and global regulatory guidelines  Â
- Comprehensive analytical support for regulatory audits and inspections  Â
Key Components of Research Bioanalysis
Bioanalytical Method Development and Validation 
- Development and validation of bioanalytical assays for regulatory compliance
- High-performance liquid chromatography (HPLC) and LC-MS/MS for drug quantification
- Assessment of drug stability, metabolism, and degradation profiles
- ICH-compliant analytical method validation for NDA, ANDA, and IND filings
Pharmacokinetic (PK) and Bioequivalence (BE) Studies 
- Quantification of drug absorption, distribution, metabolism, and excretion (ADME)
- Support for bioequivalence studies in generic and 505(b)(2) regulatory pathways
- Tissue and plasma drug concentration analysis for PK modeling
- Comparative analysis of formulation performance in vivo and in vitro
Impurity Profiling and Residual Solvent Analysis 
- Identification and quantification of potential formulation impurities
- Detection of residual solvents, degradation products, and trace contaminants
- Regulatory-compliant extractables and leachables testing
- Forced degradation studies to evaluate formulation robustness
Drug Stability and In Vitro Release Testing 
- ICH-compliant stability studies to support long-term drug viability
- In-vitro release testing (IVRT) to assess drug dissolution and diffusion rates
- In-vitro permeation testing (IVPT) for bioavailability and skin penetration analysis
- Customized stability programs for IND/NDA/ANDA submissions
Regulatory Compliance and Data Integrity 
- GMP and GLP-compliant bioanalytical testing aligned with FDA and EMA regulations
- CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory filings
- Data integrity compliance with FDA 21 CFR Part 11 and ICH guidelines
Comprehensive regulatory support for method validation and submission readiness
Ensuring Precision, Reliability, and Regulatory Compliance
At PharmaPure, our Analytical and Bioanalytical Method Development services provide essential testing solutions to ensure the accuracy, stability, and regulatory compliance of topical and transdermal drug products. By leveraging advanced analytical instrumentation, cutting-edge methodologies, and validation strategies aligned with regulatory standards, we generate high-quality, reproducible data to support formulation development, bioequivalence studies, and global regulatory submissions.  Â
With expertise in method development, validation, impurity profiling, stability assessment, and bioanalytical testing, PharmaPure ensures that pharmaceutical companies receive robust, regulatory-compliant analytical support from early-stage research through to commercial manufacturing.  
Advance Your Drug Development with PharmaPure’s Research Bioanalysis Expertise​
With scientifically guided bioanalytical testing, state-of-the-art instrumentation, and regulatory-driven validation, PharmaPure ensures that topical and transdermal drug formulations achieve optimal stability, efficacy, and regulatory success.
Ensure Analytical Precision and Regulatory Compliance with PharmaPure’s Expertise ​
With state-of-the-art analytical instrumentation, regulatory-driven validation, and expert bioanalytical testing, PharmaPure ensures that your topical and transdermal drug formulations achieve optimal performance, compliance, and commercial success.  Â
Precision Analytical Testing for Drug Development and Bioequivalence Studies
PharmaPure’s Research Bioanalysis services provide essential analytical insights to support preclinical, clinical, and regulatory submissions for topical and transdermal drug formulations. By utilizing state-of-the-art bioanalytical techniques, we ensure that precise, reliable, and regulatory-compliant data support pharmacokinetic (PK) and bioequivalence (BE) studies.
Our comprehensive bioanalytical capabilities—including drug quantification, impurity profiling, and stability assessment—help pharmaceutical companies optimize drug formulations, support IND/NDA/ANDA filings, and accelerate time to market.
Ensure the Longevity and Success of Your Product
With a strong history in stability testing, PharmaPure is your reliable partner for ensuring product quality from development to commercialization.