qNMR with two chemists in analytical lab and LCGC equipment

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.

Learn More »

Analytical chemist with sample

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.

Learn More »

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.

Learn More »

Stability chamber with chemist

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 products packaged in semi-permeable containers as well as DEA schedule II –V controlled substances.

Learn More »

a close up image of several small clear glass bottles full of a clear chemical with the Ampac Fine Chemicals label on each bottle

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.

Learn More »

an image of a female lab worker in protective eyewear looking closely at 3 vials of different colored chemicals

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.

Learn More »

X-ray Powder Diffraction Analysis

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.

Learn More »

ICP MS Machine

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.

Learn More »

a close up image of a gloved hand working with a complex machine full of wires, lights, and tubes

Nitrosamine Impurities Testing

AMPAC Analytical labs implemented test methods using LC-HRMS and GC-MS to identify trace Nitrosamines in drug substance and drug products.

Learn More »

blank pharmaceutical and drug packaging

Extractables and Leachables

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.

Learn More »

Blog | Extractable and Leachables
Blog | Elemental Impurities
News | An Open Letter From Our Parent Company’s Joerg Ahlgrimm To Our Customers
Webinar | Streamlining Analytical Method Development with a Focus on Genotoxic Impurities
white calendar icon

Contact Us

AMPAC Analytical is your partner for drug substance and drug product analytical testing services.