We offer a comprehensive suite of analytical testing services using state-of-the-art instrumentation to meet all your characterization needs.

Chromatography:

• HPLC/UPLC (UV, PDA, ELSD, CAD detection)
• GC-MS and GC-FID for volatile analysis
• LC-MS and LC-MS/MS for molecular characterization
• Ion chromatography
• Preparative and chiral chromatography

Spectroscopy:

• NMR (200-400 MHz): 1H, 13C, DEPT, 2D experiments (COSY, HSQC, HMBC, NOESY)
• FT-IR for functional group identification
• UV-Vis spectroscopy
• Fluorescence and Raman spectroscopy

Physical Testing:

• Thermal analysis (TGA, DSC)
• Karl Fischer titration
• Particle size analysis
• Melting point, optical rotation

Turnaround times vary based on the complexity of testing and current workload. We offer flexible scheduling to meet your project deadlines.

Standard turnaround times:

• Routine testing (HPLC, GC, IR, UV):3-5 business days
• NMR analysis:3-5 business days
• LC-MS/GC-MS:5-7 business days
• Method development:2-4 weeks
• Method validation:4-6 weeks
• Rush services:24-48 hours (available for most techniques)

For large projects or stability studies, we work with you to establish a mutually agreed timeline. Contact us to discuss your specific deadline requirements.

Yes, custom analytical method development is one of our core strengths. Our experienced analytical chemists develop robust, fit-for-purpose methods following ICH Q2(R1) guidelines.

Our method development process:

• Initial Assessment:Review of compound properties and testing requirements
• Literature Review:Evaluation of existing methods and pharmacopeial procedures
• Method Screening:Evaluation of multiple approaches (columns, mobile phases, detection modes)
• Optimization:Fine-tuning of conditions for optimal performance
• Pre-validation:Preliminary testing of method suitability
• Documentation:Complete method protocol and SOP

Method validation services include:

• Specificity/selectivity
• Linearity and range
• Accuracy (recovery)
• Precision (repeatability, intermediate precision)
• Detection and quantitation limits (LOD/LOQ)
• Robustness and system suitability
• Stability of analytical solutions

Yes, we provide comprehensive regulatory support and GLP/GMP-compliant documentation suitable for FDA, EMA, and other regulatory submissions.

Regulatory documentation includes:

• Certificates of Analysis (COA) with complete test results
• Method validation reports following ICH Q2(R1)
• Stability study reports per ICH Q1A
• Analytical procedures and SOPs
• Equipment qualification documents (IQ/OQ/PQ)
• Raw data packages with complete traceability
• Regulatory audit support

All testing is performed under our quality management system with full 21 CFR Part 11 compliance for electronic records. Our laboratory is audit-ready and maintains detailed chain of custody for all samples.

Sample requirements vary depending on the analytical techniques requested and number of tests to be performed.

Typical minimum sample requirements:

• HPLC/GC analysis:10-50 mg
• LC-MS/GC-MS:5-10 mg
• NMR (1H, 13C):5-10 mg (depending on solubility)
• NMR (2D experiments):10-20 mg
• FT-IR:1-5 mg
• UV-Vis:1-5 mg
• Karl Fischer:50-100 mg
• DSC/TGA:5-10 mg

For comprehensive analysis packages or method development, we recommend providing 100-500 mg. If you have limited sample availability, contact us to discuss options for micro-scale analysis.

Yes, impurity profiling and identification are critical services we provide for pharmaceutical development and regulatory compliance.

Our impurity services include:

• Impurity Detection:HPLC with multiple detection modes (UV, PDA, ELSD, CAD)
• Quantification:Accurate determination of impurity levels
• Isolation:Preparative HPLC for impurity isolation
• Structure Elucidation:NMR, MS, IR for impurity identification
• Forced Degradation:Stress testing under ICH conditions (acid, base, oxidative, thermal, photo)
• Related Substances:Comprehensive analysis per pharmacopeial requirements
• Process Impurities:Starting materials and intermediates
• Degradation Products:Identification and qualification
• Genotoxic Impurities:Detection at ppm/ppb levels
• Residual Solvents:GC analysis per ICH Q3C
• Elemental Impurities:ICP-MS per ICH Q3D

Yes, we provide comprehensive ICH-compliant stability testing programs to support pharmaceutical development and regulatory submissions.

Stability testing services:

• Long-term stability:25°C/60% RH (ICH Zone II)
• Accelerated stability:40°C/75% RH
• Intermediate conditions:30°C/65% RH
• Refrigerated storage:5°C ± 3°C
• Frozen storage:-20°C ± 5°C
• Photostability:ICH Q1B Option 1 & 2
• In-use stability:Custom conditions

Testing performed at each timepoint:

• Appearance and physical characteristics
• Assay (potency)
• Degradation products/impurities
• Water content (Karl Fischer)
• Dissolution (if applicable)
• pH or other relevant parameters

We maintain environmentally controlled stability chambers with continuous monitoring and alarming. Comprehensive stability reports are provided including trending analysis and shelf-life recommendations.

Data quality and integrity are fundamental to everything we do. We maintain a robust quality management system to ensure reliable, defensible results.

Quality assurance measures:

• All instrumentation is qualified (IQ/OQ/PQ) and maintained on regular calibration schedules
• Analytical methods are validated or verified before use
• System suitability testing performed with each analytical run
• Reference standards traceable to USP, EP, or certified suppliers
• Routine participation in proficiency testing programs
• Independent quality review of all data and reports
• Complete audit trails for electronic data (21 CFR Part 11 compliant)
• Secure sample tracking and chain of custody
• Regular internal audits and quality reviews

Our laboratory operates under ISO/IEC 17025 principles and GLP/GMP guidelines. All staff are trained in data integrity principles and current good documentation practices (CGDP).

To provide accurate testing and competitive pricing, we need some basic information about your sample and testing requirements.

Required information:

• Compound Information:Chemical name, structure, CAS number, molecular formula
• Sample Details:Physical form, purity, quantity available
• Testing Requirements:Specific tests needed or regulatory requirements
• Timeline:When results are needed
• Intended Use:R&D, QC, regulatory submission, etc.

Helpful additional information:

• Known impurities or degradation products
• Solubility information
• Existing analytical methods (if available)
• Stability considerations (light-sensitive, hygroscopic, etc.)
• Safety data (SDS/MSDS)

We provide detailed quotes within 24-48 hours of receiving complete information. Our technical team is available to discuss your testing needs and recommend appropriate analytical approaches.

Yes, we are equipped and licensed to handle controlled substances and hazardous materials under appropriate safety protocols.

Controlled substances:

• DEA-licensed facility for Schedule I-V compounds
• Secure storage and handling protocols
• Complete chain of custody documentation
• Destruction services with proper documentation

Hazardous materials:

• Proper containment and ventilation systems
• Trained personnel in hazmat handling
• Appropriate PPE and safety equipment
• Hazardous waste disposal through certified contractors
• Compliance with OSHA, EPA, and local regulations

Please provide SDS/MSDS with sample submissions. We evaluate all safety considerations before accepting samples to ensure proper handling protocols are in place.

Yes, we provide comprehensive method transfer services to establish your existing analytical methods in our laboratory.

Method transfer process:

• Method Review:Evaluation of method protocol and validation data
• Equipment Assessment:Verification that we have equivalent or suitable instrumentation
• Standard/Material Transfer:Obtaining reference standards and system suitability samples
• Method Qualification:Demonstration that the method performs adequately in our lab
• Comparative Testing:Analysis of common samples to demonstrate equivalency
• Documentation:Method transfer report documenting successful transfer

We work collaboratively during the transfer process to address any differences in equipment or materials. Successful method transfer typically takes 2-4 weeks depending on method complexity.

Our pricing is competitive and transparent. We provide detailed quotes based on your specific testing requirements.

Pricing structure:

• Per-sample testing:Fixed price per test/technique
• Method development:Time and materials or fixed price
• Method validation:Package pricing based on validation scope
• Stability programs:Per-timepoint pricing with volume discounts
• Rush services:50-100% surcharge depending on urgency

Payment terms:

• New clients:50% deposit, balance upon completion
• Established clients:Net 30 with approved credit
• Long-term programs:Monthly billing or milestone-based
• Payment methods:Wire transfer, ACH, credit card, purchase orders

Volume discounts are available for large sample sets or ongoing projects. Contact us for a detailed quote.

Proper sample packaging and shipping ensures sample integrity and laboratory safety. We accept samples via major carriers.

Shipping guidelines:

• Packaging:Use sturdy containers with adequate cushioning
• Primary container:Seal samples in leak-proof vials or bags
• Secondary containment:Place in sealed plastic bag or container
• Labeling:Clearly label each sample with unique identifier
• Documentation:Include sample submission form with testing requirements
• SDS/MSDS:Include safety data sheets for hazardous materials
• Temperature control:Use ice packs or dry ice if needed (clearly marked)

Shipping address:

ChemContract Research Inc
Attn: Analytical Services
9121 Atlanta Ave, Suite 800
Huntington Beach, CA 92646

Carriers:FedEx, UPS, DHL (no USPS for hazardous materials)

Contact us before shipping controlled substances or hazardous materials to arrange proper documentation and handling protocols.

Absolutely. Our experienced analytical chemists are available to discuss your analytical challenges and recommend optimal testing strategies.

Consultation services include:

• Selection of appropriate analytical techniques for your compound
• Troubleshooting existing analytical methods
• Problem-solving for difficult separations or analyses
• Regulatory strategy for analytical requirements
• Design of stability study protocols
• Interpretation of analytical results
• Technology assessments for analytical instrumentation

Initial technical consultations are complimentary. For extended consulting engagements, we offer hourly or project-based consulting services. Contact us to schedule a consultation with one of our analytical experts.

We combine state-of-the-art instrumentation with deep scientific expertise and personalized service to deliver exceptional analytical solutions.

Our differentiators:

• Expert Scientists:PhD-level analytical chemists with 10-30+ years experience
• Comprehensive Capabilities:Full suite of techniques under one roof
• Regulatory Excellence:Deep understanding of FDA, ICH, and USP requirements
• Flexible Service:From single samples to full validation programs
• Quick Turnaround:Rush services available when you need them
• Collaborative Approach:We work as an extension of your team
• Quality Focus:Rigorous QC and complete data transparency
• 25+ Years Experience:Trusted partner since 2000

We don't just run samples – we provide insights and solutions. Our goal is to be your strategic analytical partner, supporting your success from R&D through commercialization.

Contact us:+1 (714) 732-8549 | [email protected]