Comprehensive Analytical Release Testing
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.
Method Development
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.
Method Validation / Transfer
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.
Stability Program
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 product packaged in semi-permeable containers as well as DEA schedule II –V controlled substances.
Reference Standard Qualification
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.
Compound Characterization
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.
Elemental Impurities – USP<232>, <233>, ICH Q3D
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.
Our laboratories are equipped to handle:
Controlled Substances, High Potency Compounds, & Cytotoxic Compounds
AMPAC Analytical offers NDMA Analyses of API and DP
AMPAC Fine Chemicals Expands Its Analytical Services to Meet Accelerating Business Demands
Together AMPAC Fine Chemicals and SK biotek Offer an Expanded Value Proposition in the Worldwide CDMO Space
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AMPAC Analytical is your partner for drug substance and drug product analytical testing services.