AMPAC Analytical provides full service method development for our customers based on decades of industry experience. From initial research including separation mode selection, stationary phase selection, mobile phase selection through to lifecycle method improvements, we work closely with customers to produce methods which meet or exceed their analytical needs.
AMPAC Analytical has extensive experience in the validation and transfer of methodology to support pharmaceutical testing for all phases of products. Our team will work with you in determining phase appropriate validations to support product development. We work with a variety of LCs and GCs to validate methods for assay/purity/impurity determinations. AMPAC Analytical can draft the necessary validation protocols and reports to support your regulatory and filing needs.
AMPAC Analytical is your partner for cGMP product testing and release services for all phases of drug development and commercial manufacturing. We provide a wide array of release testing services for Raw Material, Intermediate, API and Drug Product testing. Our labs are equipped to handle hazardous, cytotoxic/high potency compounds as well as Controlled Substances Schedule II through V.
AMPAC Analytical offers ICH stability storage and testing to support all of your cGMP stability requirements. We offer a wide range of ICH storage conditions for stability storage of long-term, intermediate and accelerated testing. Our facilities are also capable of performing stability storage for drug products packaged in semi-permeable containers as well as DEA schedule II –V controlled substances.
AMPAC Analytical conducts reference standard qualifications for proprietary customer compounds, including novel raw materials, intermediates, and active pharmaceutical ingredients. We offer cGMP qualification and characterization services to establish the identity and potency for Certified Reference Standards (CRS). We apply multiple spectroscopic techniques (including IR, NMR, and MS) to establish identity and apply titration, HPLC, GC, and other techniques to establish potency values.
AMPAC Analytical provides a broad range of compound characterization services including wet chemistry analyses, spectroscopic analysis, and chromatographic analysis. AMPAC Analytical provides accurate analytical results and comprehensive expertise to support failure analysis, foreign material identification, formulation development, and synthetic process development.
AMPAC Analytical offers X-ray Powder Diffraction (XRPD) Analysis, a powerful, non-destructive and rapid technique for analyzing a wide range of materials, including pharmaceuticals, metals, polymers, catalysts, plastics, etc.
AMPAC Analytical is your premier site for the development of methods for the determination of elemental impurities. USP chapter <232> and USP chapter <233>, along with ICH Q3D, aim to standardize the allowable limits of elemental impurities. With the implementation of these limits slated for early 2018, it will be critical to get your existing APIs, Drug Products, and excipients as well as future products compliant with these procedures.
AMPAC Analytical labs implemented test methods using LC-HRMS and GC-MS to identify trace Nitrosamines in drug substance and drug products.
AMPAC Analytical can review your analysis and testing needs for extractables and leachables for any forms and delivery systems to comply with the strictest standards necessary.
- Method Development »
- Method Validation / Transfer »
- Comprehensive Analytical Release Testing »
- Stability Program »
- Reference Standard Qualification »
Our laboratories are equipped to handle:
Controlled Substances, High Potency Compounds, & Cytotoxic Compounds
White Paper | Method Development & Impurity Control in Late-Phase API Manufacturing
Blog | Dynamic Vapor Sorption
Blog | Keys to Effective Method Development
Blog | Phase-Appropriate Method Development and Why It Matters
Blog | TCB* With Your TTC Needs
Blog | Raw Materials Testing: Trust – and Verify – Your Sources
AMPAC Analytical is your partner for drug substance and drug product analytical testing services.