Analytical Chemistry FAQs
What analytical methods can Exemplify develop for both drug substance and drug product?
Exemplify develops and validates analytical methods for assays, impurities, dissolution, residual solvents, and chiral separations across both drug substance (DS) and drug product (DP). Methods are built under ICH Q2(R2) guidelines, ensuring precision, linearity, accuracy, and robustness for GMP and non-GMP applications.
What types of HPLC and LC-MS systems are used in your analytical lab?
Our laboratories house multiple UHPLC and HPLC systems equipped with PDA, ELSD, CAD, and fluorescence detectors, as well as LC-MS/MS systems including triple quadrupole instruments for trace quantitation. This setup allows us to handle complex impurity profiling and method development with sub-ppm sensitivity.
Can you perform chiral separations and column screening?
Yes. We offer chiral HPLC and SFC separations using six-column chiral screening platforms. These systems allow rapid method development for enantiomeric purity assessment and chiral impurity quantification.
Do you have GC-MS and headspace GC-FID capability for residual solvent testing?
We do. Exemplify operates GC-MS and GC-FID systems with headspace autosamplers for volatile and semi-volatile impurity analysis. Methods follow USP <467> and ICH Q3C guidance for residual solvent classification and limit verification.
Do you offer release testing for drug substance and drug product?
Absolutely. Exemplify offers independent drug product and drug substance release testing upon successful method transfer.
Do you perform ICH stability and forced degradation studies for drug substance and drug product?
We do. We perform ICH stability studies under long-term and accelerated conditions as well as forced degradation studies to demonstrate stability-indicating nature of analytical methods.
What are your photostability testing conditions under ICH guidelines?
Our ICH photostability chambers are qualified for ICH Q1B conditions, including visible and UV light exposure at controlled temperature and humidity. We monitor photostability profiles in both solid and solution state to assess photosensitivity and provide full data packages including chromatographic impurity profiling post-exposure.
How do you validate analytical methods for cGMP release testing?
We validate non-compendial release methods using a stage appropriate approach. Each validation covers specificity, linearity, precision, accuracy, range, robustness, and detection limits per ICH Q2(R2). Validation protocols and summary reports are approved through our QA system, and validation data are retained as part of the GMP batch release package.
Can you perform impurity and degradant identification using LC-MS?
Yes. Our LC-MS and LC-MS/MS systems enable impurity and degradant identification through high-resolution mass analysis and fragmentation studies. Structural elucidation is supported by comparison to synthesized or isolated reference standards.
Do you support PGI (potential genotoxic impurity) and PMI (potential mutagenic impurity) method development?
We do. Exemplify develops and validates LC-MS or GC-MS methods for PGI quantitation at sub-ppm levels, including nitrosamine and alkylating impurity assessments, ensuring compliance with ICH M7 guidance.
Do you support nitrosamine assessment and method development?
We do. Exemplify develops and validates LC-MS or GC-MS methods for nitrosamine quantitation at sub-ppm levels for both drug substance and drug product. In addition, we can synthesize nitrosamine analogs or compounds for testing.
What stability conditions do you offer (temperature and humidity ranges)?
Our stability chambers operate at -80°C, -20°C, 2–8°C, 25°C/60%RH, 30°C/65%RH, and 40°C/75%RH, consistent with ICH Q1A–F. Both accelerated and long-term studies are supported with full analytical testing and data trending.
Are your stability chambers qualified for ICH Zones I–IV?
Yes. Exemplify’s stability systems are mapped and qualified to cover all ICH climatic zones, enabling clients to meet global regulatory expectations for product registration.
Can you transfer analytical methods to a client’s internal QC lab?
We routinely perform analytical method transfer through comparative validation or co-validation studies. Transfer protocols include accuracy, precision, and system suitability criteria aligned to both sites’ instrumentation.
Can you transfer analytical methods in from another CRO?
We routinely transfer analytical methods and qualify and/or validate as appropriate.
Do you perform forced degradation and stress testing studies?
Yes. Exemplify conducts stress studies under thermal, oxidative, hydrolytic, and photolytic conditions to assess intrinsic stability and degradation pathways. The results demonstrate stability-indicating nature of the methods and guide impurity identification and method specificity assessments.
How do you ensure data integrity and traceability for cGMP analytical results?
Our systems operate with audit trails, user-level access controls, and electronic data review workflows. All analytical instruments are integrated into validated software platforms compliant with 21 CFR Part 11.
Do you provide analytical support for formulation development projects?
Yes. Analytical scientists collaborate closely with formulation teams to develop dissolution, content uniformity, and stability-indicating methods. This integration accelerates formulation optimization and regulatory documentation.
What is your turnaround time for analytical sample testing?
Typical non-GMP sample turnaround is 5–10 business days, while GMP release and stability testing follow predefined timelines per client quality agreements. Expedited testing can be accommodated under project-specific agreements.
Can you perform raw material and excipient qualification testing?
We perform full incoming raw material analysis, including identity, purity, and moisture testing per compendial standards. Vendor qualification data and CoAs are reviewed by QA to ensure material suitability for GMP use.
Can Exemplify provide validated dissolution and assay methods for clinical supply and release?
Yes. We develop and validate USP/ICH-compliant dissolution and assay methods tailored to the specific dosage form and release mechanism. Validation includes sink condition verification and discriminatory power assessment.
Do you offer impurity reference standard synthesis?
Exemplify synthesizes, purifies, and characterizes impurity and degradant standards in-house using NMR, MS, and HPLC purity confirmation. This capability ensures rapid availability of qualified standards for analytical use.
What services do you offer for primary reference standards?
Absolutely. Exemplify offers a full range of reference standard services including synthesis, purification, characterization with data interpretation, potency determination, and annual recertification.