Analytical Services

1. Analytical Services By Pharmaffiliates • Method Development • Method Validation & Transfer • Stability Studies • Contract Analysis • Impurity Profiling • Extractible & Leachable • Forced Degradation Studies • Trace Metal Analysis Corporate Presentation2017 Pharmaffiliates

2. METHOD DEVELOPMENT Full method development procedures are complex, extended, and expensive endeavors. These studies are usually required when data from the analysis is going to be submitted to regulatory authorities for certification of a new or amended drug application. The analytical method is tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantization limit and robustness. Corporate Presentation2017 Pharmaffiliates

3. METHOD VALIDATION Regulatory agencies expect to see some level of validation for non-compendial methods. Whether your submission is an IND, NDA, IMPD, MAA, CTA, ANDA we can provide the appropriate level of validation for test methods in your CMC section. All relevant guidelines, such as the ICH guidelines are followed. We typically validate test methods for API, drug products, and drug product containers. The usual validation process involves a validation protocol that is signed by both the client and Pharmaffiliates. We complete the laboratory work in agreement with the protocol made for the test method that is being validated. We can summarize validation results in the final version of the test method and/or describe the results in detail in a stand-alone validation report. Some typical test method validation parameters are ruggedness, linearity and range, limit of detection and limit of quantization, accuracy, precision, specificity, robustness and solution stability. Corporate Presentation2017 Pharmaffiliates

4. STABILITY STUDIES We provide stability testing on Drug products specially during development and post surveillance study. Our stability operations have extensive storage capacity for all ICH conditions as well as custom storage conditions. Our stability chambers are continuously monitored through a computer database system and are on generator back-up. CORE TESTING AND ANALYSIS EXPERTISE R&D preliminary studies, finished product, API’s, high throughput QC stability and release testing, comparator studies and additional capabilities for photo stability studies. All stability studies are performed in accordance with the ICH Q1A-Q1F guidelines. We develop stability Indicating Methods and made use of those while performing stability studies for APIs and Drug products. Stability ovens, walk -in Chambers and analytical instruments are fully qualified. Computerized Laboratory instruments are 21CFR part 11 compliant. Corporate Presentation2017 Pharmaffiliates

5. STRUCTURE ELUCIDATION Pharmaffiliates Analytics offers a broad spectrum of structural analytical methods, taking in everything from high-field NMR spectroscopy to single crystal X-ray diffractometry. In addition to structural elucidation for R&D issues, we also focus on the reliable identification of materials and end products and the elucidation of unknown secondary components. In the area of pharmaceutical analytics, we validate calibration substances under GMP conditions. We work through complex issues step-by-step and offer a number of fixed price packages for this purpose. For those looking to perform evaluations themselves, we provide spectra in the form of raw data (e.g. FID). We employ chromatographic combination methods, particularly LC/MS and GC/MS, for the direct investigation of substance blends. In this case, high-resolution mass spectrometry enables unambiguous structural assignments. Our portfolio for structural analytics is rounded off by quantitative analysis, e.g. using NMR. Pharmaffiliates makes uses of state-of-the-art methods and technologies carrying specific advantages. MOST DETAILED STRUCTURAL INFORMATION Through our combined high-end analytical methods, we have access to the highest structural resolution power ! In consultation with our client, we establish the most efficient approach and define a detailed work-plan with clearly identified milestones. Corporate Presentation2017 Pharmaffiliates

6. WE OFFER ANALYTICAL TESTING UTILIZING Ultraviolet light (UV) Gas chromatography-mass spectrometry (GC-MS) High-performance liquid chromatography (HPLC) Ultra performance liquid chromatography (UPLC) Fourier transform infrared spectroscopy (FTIR) Inductively coupled plasma (ICP) Inductively coupled plasma mass spectrometry (ICP-MS) Corporate Presentation2017 Pharmaffiliates

7. Pharmaffiliates analytical testing services offer a full range of material testing analysis aimed at discovering impurities in raw materials/finished products and confirming product label claims. BENEFITS With analytical chemistry capabilities that cover a wide range of instrumental and classical wet chemistry techniques, Pharmaffiliates analytical testing services provide solutions to problems within the field of material science. Based on recognized international standards, our analytical chemical testing helps promote consumer safety through regulatory compliance. Corporate Presentation2017 Pharmaffiliates