Analytical & Quality Sciences

Our Analytical & Quality Science Capabilitie

Analytical Method Development

We support the development and optimization of analytical procedures for drug substances, drug products, excipients, botanical ingredients and selected formulation components, according to the intended analytical purpose.

Method-development activities may include:

• Selection of suitable analytical technique
• Sample preparation optimization
• Solvent and diluent selection
• Mobile-phase optimization
• Chromatographic-condition optimization
• Detection-wavelength selection
• Column selection
• Elution-mode optimization
• Optimization of flow rate and temperature
• Injection-volume optimization
• Run-time optimization
• Peak-resolution assessment
• System suitability evaluation
• Robustness-oriented studies

The analytical procedure is designed around the attributes that need to be measured and the performance required for its intended use. ICH Q14 describes analytical procedure development as a lifecycle-oriented activity and emphasizes product understanding, procedure performance and analytical procedure control.

HPLC & UPLC-Based Analysis

HPLC and UPLC-based analytical approaches are important tools for quantitative and qualitative pharmaceutical analysis.

Depending on the product and analytical objective, chromatographic methods may be developed for:

• Assay determination
• Drug-content determination
• Related substances
• Degradation products
• Impurity profiling
• Dissolution-sample analysis
• Stability samples
• Marker-compound estimation
• Botanical extract characterization
• Formulation analysis
• Comparative formulation studies

Method-development parameters may include:

• Stationary-phase selection
• Mobile-phase composition
• Buffer selection
• pH optimization
• Flow rate
• Column temperature
• Detection wavelength
• Gradient/isocratic conditions
• Sample concentration
• Dilution scheme

Where appropriate, chromatographic methods may be designed to distinguish the active ingredient from excipients, impurities and degradation products.

Analytical Method Validation

Analytical method validation establishes whether an analytical procedure is suitable for its intended purpose.

Depending on the method and intended use, validation studies may consider:

Specificity / Selectivity

Ability of the procedure to measure the intended analyte in the presence of relevant components such as excipients, impurities or degradation products.

Accuracy

Assessment of the closeness of measured values to the expected or accepted reference value.

Precision

Evaluation of the variability of analytical results under defined conditions.

This may include:

• Repeatability
• Intermediate precision
• Reproducibility, where applicable

Linearity & Range

Evaluation of the relationship between analytical response and analyte concentration over an appropriate range.

Detection & Quantitation

Where applicable, determination of:

• Limit of detection (LOD)
• Limit of quantitation (LOQ)

Robustness

Evaluation of the effect of deliberate variations in relevant analytical parameters.

System Suitability

Establishment of appropriate system-performance checks before or during analytical sequences.

ICH Q2(R2) describes validation as demonstrating that an analytical procedure is suitable for its intended purpose and identifies performance characteristics appropriate to different analytical uses.

Stability-Indicating Analytical Methods

A stability-indicating analytical procedure is particularly important when monitoring pharmaceutical products during stability studies.

Our analytical development approach can incorporate studies designed to distinguish the active ingredient from relevant degradation products and other components.

Potential stress conditions may include:

• Acidic hydrolysis
• Alkaline hydrolysis
• Oxidative stress
• Thermal stress
• Humidity exposure
• Photolytic stress
• Other scientifically justified stress conditions

Stress studies can provide information regarding degradation pathways and help demonstrate the stability-indicating capability of the analytical procedure. ICH stability guidance specifically recognizes the role of stress testing in identifying degradation products and supporting the development and validation of stability-indicating analytical procedures.

Drug-Content & Assay Determination

Accurate quantification of the active pharmaceutical ingredient is fundamental to pharmaceutical product evaluation.

We support analytical evaluation of:

• API assay
• Drug content
• Content uniformity-related measurements
• Active-marker content
• Potency-related measurements
• Formulation-to-formulation comparison
• Stability-sample assay

Depending on the product, appropriate analytical techniques may be selected based on the physicochemical properties of the analyte and the intended purpose of the test.

Dissolution & In-Vitro Drug Release Studies

Dissolution and drug-release studies provide important information about the in-vitro performance of pharmaceutical dosage forms.

We support dissolution/release research for appropriate dosage forms, including:

• Immediate-release tablets
• Capsules
• Modified-release formulations
• Sustained-release systems
• Controlled-release formulations
• Oral films
• Selected semisolid/topical systems
• Novel drug-delivery systems

Development considerations may include:

• Dissolution medium
• Medium volume
• Apparatus selection
• Agitation speed
• Temperature
• Sampling intervals
• Filtration
• Sample preparation
• Analytical quantification
• Release-profile comparison

USP General Chapter <711> provides a standardized framework for dissolution testing, while USP also identifies dedicated approaches for dissolution procedure development and validation.

For advanced delivery systems, release studies may be used to compare formulations and investigate release kinetics and formulation-dependent performance.

In-Vitro Release & Release-Kinetics Analysis

Beyond determining the percentage of drug released, release data can be analyzed to understand formulation behaviour.

Depending on the research objective, release profiles may be evaluated using appropriate mathematical models, such as:

• Zero-order model
• First-order model
• Higuchi model
• Korsmeyer–Peppas model
• Other appropriate mechanistic or empirical models

Evaluation may provide insight into:

• Diffusion-controlled release
• Dissolution-controlled release
• Matrix-controlled release
• Polymer-dependent release
• Sustained-release behaviour
• Controlled-release mechanisms

The selected model should be interpreted in the context of the formulation and experimental design rather than relying solely on statistical fit.Physicochemical Characterization

Physicochemical characterization is used to understand product properties that can influence quality, performance, stability and manufacturability.

Depending on the dosage form, characterization may include:

Solid Dosage Forms

• Appearance
• Weight variation
• Hardness
• Friability
• Disintegration
• Drug content
• Dissolution
• Moisture content

Semisolid Formulations

• Appearance
• Homogeneity
• pH
• Viscosity
• Rheological behaviour
• Spreadability
• Extrudability
• Phase stability

Liquid Formulations

• Appearance
• pH
• Viscosity
• Density
• Clarity
• Sedimentation
• Redispersibility
• Particle size, where applicable

Advanced Delivery Systems

• Particle size
• Polydispersity index
• Zeta potential
• Encapsulation efficiency
• Drug loading
• Morphology
• Physical stability
  
  Stability Studies

Stability studies are designed to monitor changes in product quality over time under defined storage conditions.

Depending on the product and development stage, stability evaluation may monitor:

• Appearance
• Colour
• Odour
• Assay
• Drug content
• Degradation products
• Dissolution
• Disintegration
• pH
• Moisture
• Viscosity
• Particle size
• Zeta potential
• Physical separation
• Microbiological quality, where applicable

Stability testing should focus on attributes that are susceptible to change during storage and that may influence product quality, safety or performance. ICH stability guidance identifies physical, chemical, biological and microbiological attributes as appropriate considerations depending on the product.

Forced Degradation & Degradation-Product Evaluation

Forced degradation studies can be used during analytical development to understand the degradation behaviour of an API or formulation.

Potential studies include:

Drug Substance → Stress Exposure → Degradation Profile → Separation/Detection → Method Optimization → Stability-Indicating Procedure

The resulting information may help with:

• Identification of degradation pathways
• Selection of appropriate analytical conditions
• Evaluation of method specificity
• Development of stability-indicating methods
• Understanding formulation-related degradation
• Supporting stability studies

Stress conditions should be scientifically justified for the specific molecule and product.

Analytical Characterization of Herbal & Botanical Products

Analytical science is particularly important for herbal, Ayurvedic, phytopharmaceutical and nutraceutical products, where complex chemical composition and batch-to-batch variability can present additional challenges.

Potential analytical activities include:

• Botanical extract characterization
• Marker-compound estimation
• Phytochemical profiling
• Chromatographic fingerprinting
• Quantification of selected bioactive compounds
• Extract standardization
• Comparative batch analysis
• Stability monitoring of botanical markers

Depending on the research objective, techniques such as HPLC, HPTLC, UV-Visible spectroscopy, GC/GC-MS and other suitable analytical approaches may be considered.

Analytical Support for Novel Drug Delivery Systems

Advanced drug-delivery systems often require multiple complementary analytical measurements.

For example:

Nanoparticles

• Particle size
• PDI
• Zeta potential
• Drug loading
• Encapsulation efficiency
• Morphology
• Drug release

Liposomes & Vesicular Systems

• Vesicle size
• Size distribution
• Zeta potential
• Encapsulation efficiency
• Drug loading
• Physical stability
• Drug release

Nanoemulsions

• Droplet size
• PDI
• Zeta potential
• Physical stability
• Active content
• Release behaviour

Nanogels

• Particle/hydrogel characteristics
• Swelling behaviour
• Drug loading
• Release profile
• Stability

Analytical characterization is integrated with formulation development to understand the relationship between formulation composition, process variables and product performance.

Analytical Support for Respiratory & Inhalation Products

For suitable inhalation-development projects, analytical science can complement aerosol-performance and formulation studies.

Potential analytical evaluations may include:

• Drug content
• Delivered dose
• Assay
• Degradation products
• Formulation stability
• Particle-size-related measurements
• Release/performance measurements
• Device–formulation compatibility

For inhalation products, analytical testing can be integrated with performance measurements such as aerosol particle-size distribution and delivered-dose assessment where appropriate.

Analytical Support for Ophthalmic Products

Ophthalmic formulations require careful analytical and quality evaluation because of their intended route of administration and sensitivity to formulation changes.

Potential analytical parameters include:

• Drug assay
• Content uniformity
• pH
• Osmolality
• Viscosity
• Particle size for suspensions/nanocarriers
• Degradation products
• Release profile
• Physical stability
• Container compatibility

For sterile ophthalmic products, analytical development can be complemented by appropriate microbiological and sterility-related quality testing within the applicable development framework.

Quality-Risk Assessment

Analytical development and quality evaluation can be strengthened through a science- and risk-based approach.

Quality-risk assessment may consider:

• Critical Quality Attributes (CQAs)
• Critical Material Attributes (CMAs)
• Critical Process Parameters (CPPs)
• Analytical procedure parameters
• Sources of analytical variability
• Product-related risks
• Process-related risks
• Stability-related risks
• Packaging-related risks

Risk-based tools may include:

• Risk ranking
• Risk matrices
• Fishbone analysis
• Failure Mode and Effects Analysis (FMEA)
• Cause-and-effect analysis
• Experimental studies
• Design of Experiments (DoE)

ICH quality guidance includes dedicated frameworks for analytical procedures, stability, specifications, pharmaceutical development and quality risk management.

Quality by Design & Analytical Development

Analytical development can be integrated with a broader Quality by Design (QbD) framework.

A systematic approach may involve:

Quality Target Product Profile (QTPP)
↓
Critical Quality Attributes (CQAs)
↓
Analytical Target Profile (ATP), Where Applicable
↓
Risk Assessment
↓
Analytical Procedure Development
↓
Optimization & Robustness Assessment
↓
Method Validation
↓
Analytical Control Strategy
↓
Lifecycle Management

ICH Q14 specifically describes the analytical procedure lifecycle and allows development knowledge, including appropriately generated robustness information, to contribute to subsequent validation activities where scientifically justified.

Reference Standards & System Suitability

Reliable analytical results depend on appropriate reference materials and adequate system-performance controls.

Analytical studies may therefore consider:

• Selection of suitable reference standards
• Standard preparation
• Standard solution stability
• Sample solution stability
• Calibration procedures
• System suitability criteria
• Replicate injections
• Chromatographic performance
• Analytical sequence design

ICH Q2(R2) emphasizes the use of suitably characterized reference materials and recognizes system suitability as an integral part of analytical procedures.

Analytical Method Transfer & Lifecycle Considerations

Where an analytical procedure moves from development into routine use or another laboratory, appropriate transfer and verification activities may be required.

Considerations can include:

• Method documentation
• Analytical procedure understanding
• Transfer protocol
• Comparative testing
• Acceptance criteria
• Equipment differences
• Analyst-to-analyst variability
• Laboratory-to-laboratory variability
• Method robustness
• Ongoing performance monitoring

This lifecycle perspective helps ensure that analytical procedures remain appropriate as the product progresses through development.

Product / API / Formulation → Analytical Target & Quality Requirements → Risk Assessment → Analytical Method Development → Optimization & System Suitability → Forced Degradation / Specificity Assessment → Analytical Method Validation → Assay / Content / Impurity / Release Testing → Stability Evaluation → Data Interpretation & Quality Assessment → Analytical Control Strategy → Product Development & Lifecycle Support

Key Analytical Challenges We Address

Our analytical-development approach can help address challenges such as:

• Complex formulation matrices
• Low drug concentration
• Poor analyte solubility
• Interference from excipients
• Co-eluting components
• Degradation-product separation
• Stability-related degradation
• Complex botanical matrices
• Low-level impurities
• Poor peak resolution
• Sample instability
• Analytical variability
• Difficult dissolution profiles
• Advanced delivery-system characterization
• Method robustness challenges

Integrated Analytical Support Across Product Development

Analytical science at HSP can be integrated across multiple research areas:

Research Area	Analytical & Quality Support
Pre formulation	API characterization, compatibility, solubility and physicochemical evaluation
Formulation Development	Assay, content, pH, viscosity, dissolution and formulation characterization
NDDS	Particle size, PDI, zeta potential, encapsulation and release
Herbal & Ayurvedic Research	Marker compounds, fingerprinting and standardization
Nutraceuticals	Bioactive/marker quantification, assay and stability
Respiratory Products	Assay, delivered dose and formulation-performance support
Ophthalmic Products	Assay, pH, osmolality, viscosity, release and stability
Cosmetic & Cosmeceutical Products	Active/marker analysis, physicochemical characterization and stability
Stability Studies	Assay, degradation products and relevant physical/chemical attributes
Product Optimization	Analytical evaluation of formulation and process variables

Why Choose HSP Research Group LLP?

Science-Driven Analytical Development

Analytical procedures are developed with consideration of the intended purpose and product characteristics.

Integrated Formulation & Analytical Expertise

Analytical evaluation is connected directly with formulation development rather than treated as an isolated activity.

Stability-Focused Approach

Stability-indicating analytical strategies can support understanding of product changes and degradation behaviour.

Advanced Product Characterization

Analytical support can be adapted for conventional formulations as well as selected novel drug-delivery systems.

Risk-Based Quality Thinking

Quality attributes and analytical risks can be evaluated using systematic, science-based approaches.

Development-Lifecycle Perspective

Analytical methods can be considered from early development through validation, stability evaluation and subsequent product-development stages.

From Analytical Data to Product Understanding

At HSP Research Group LLP, analytical science is more than measurement—it is a tool for understanding product quality, formulation behavior, stability and performance.

By integrating analytical method development, validation, chromatographic analysis, dissolution and release testing, physicochemical characterization, stability studies and quality-risk assessment, we aim to generate meaningful data that supports informed decisions throughout pharmaceutical product development.

Partner with HSP Research Group LLP

Develop • Analyze • Characterize • Validate • Optimize

Partner with us for:

Analytical Method Development | Analytical Method Validation | Stability-Indicating Methods | HPLC/UPLC Analysis | Assay & Drug Content | Dissolution & Release Studies | Physicochemical Characterization | Stability Studies | Forced Degradation | Quality-Risk Assessment | Analytical Support for NDDS | Herbal & Botanical Analysis | Nutraceutical Analysis

Building Confidence Through Analytical Science

Reliable Methods. Meaningful Data. Better Product Decisions.