Routine & Custom Pharmaceutical Testing

Compendial Testing

Analytical Services
Laboratory Services
Method Development
Routine and Custom Testing

Compendial Testing Services at Alcami

Trusted Expertise in Compendial Testing

At Alcami, we provide comprehensive compendial testing services designed to meet the diverse needs of our clients. With over 45 years of experience in adhering to compendial standards such as USP, Ph.Eur., BP, JP, ChP, FCC, and ACS, our team possesses a deep understanding of these stringent requirements. We employ state-of-the-art methodologies to ensure accurate and timely results, offering a standard turnaround time of just 10 days, with a 1-day rush option available.

  • Our Comprehensive Compendial Testing Services

    Alcami offers a wide range of testing services to support your product’s journey from development to market. Our expertise includes:

  • Wet Chemistry Testing

    Reliable analysis using classic wet chemistry techniques to meet compendial standards.

  • Fourier-Transform Infrared Spectroscopy (FTIR)

    Advanced FTIR techniques for precise identification of chemical compounds.

  • Liquid Chromatography

    (HPLC, UPLC, Ion Chromatography, and TLC) – High-performance liquid chromatography services tailored for accurate separation and quantification of your samples.

  • Gas Chromatography

    Including Gas Sampling Testing – Comprehensive gas chromatography solutions for a variety of applications.

  • Ultraviolet-Visible Spectroscopy (UV-Vis)

    Precise UV-Vis analysis for quantifying and identifying substances.

  • Atomic Absorption Spectroscopy (AAS)

    Sensitive detection of metal elements using atomic absorption techniques.

  • Inductively-Coupled Plasma with Mass Spectroscopy (ICP-MS)

    Accurate trace element analysis with ICP-MS.

  • Titrations

    High-precision titrations for determining the concentration of analytes.

  • Thermogravimetric Analysis (TGA) / Differential Scanning Calorimetry (DSC)

    Thermal analysis to characterize material properties.

  • X-Ray Powder Diffraction (XRPD)

    Structural analysis using XRPD for crystalline materials.

  • Viscosity Measurements

    Accurate determination of viscosity for various substances.

  • Particle Size Analysis

    (Sieve, Malvern 3000, Malvern Zetasizer, Sympatec, MFI) – Comprehensive particle size analysis services for quality control and product development.

Chemistry

Alcami’s scientists have more than 45 years of experience developing analytical methods and procedures to support drug development and manufacture. Equipped with first-in-class lab and process analytical technologies, our labs are flexible and designed to achieve optimal results in an efficient and timely manner.
CORE CHEMISTRY CAPABILITIES

Compendial monograph testing per the USP, EP, BP, JP, FCC, ACS

Analytical method development, verification, transfer, and validation studies for small molecules and biopharmaceuticals

Drug substance reference standard characterization studies

API characterization

Heavy metals, trace metal impurities, and elemental impurities testing per USP <232>, <233>

Organometallics

Catalyst control

Residual solvents as per USP <467>

Container and closure system integrity testing by vacuum and pressure decay

Disinfectant qualification and disinfectant efficacy studies

Liquid chromatography

Microbiology

At Alcami, we combine decades of microbiological expertise, developed from serving the biotech, pharmaceutical, and medical device industries, to provide the most current and effective methodologies for developing our customers’ biologic and biopharmaceutical products.
CORE MICROBIOLOGY CAPABILITIES

Analysis of non-sterile products

Antimicrobial effectiveness (preservative efficacy) validation and testing

Biological indicator total viable spore count, purity, and post-exposure testing

Container closure integrity testing (microbial ingress and dye immersion)

Disinfectant efficacy/disinfectant qualification studies

Endotoxin indicator testing for depyrogenation studies

Environmental monitoring and facility support

Gel clot limulus amebocyte lysate (LAL) assay

Incubation and enumeration of environmental monitoring plates

Inhibition/enhancement studies

In-use admixture studies

Kinetic chromogenic LAL assay | Kinetic turbidimetric LAL assay

Method suitability

Microbial assay

Microbial enumeration and validation

Microbial identification (genotypic)

Microbial limits test

Pharmaceutical water system validation and routine testing (WFI, purified water, clean steam)

Protocol-generated studies in support of regulatory filings

Rapid sterility

Sterile product testing

Sterility testing by membrane filtration and direct transfer with barrier isolator technology

Tests for specified organisms

Commitment to Quality and Regulatory Compliance

Alcami is dedicated to maintaining the highest standards of quality and regulatory compliance. Our rigorous approach to compendial testing ensures that your products meet all necessary regulatory requirements, providing reliable support throughout your product’s lifecycle.

Related Topics
Drug Product Manufacturing
Laboratory Services
Biologics
Analytical Method Development
Contact Alcami
Summary

Alcami offers comprehensive compendial testing services tailored to meet diverse client needs. Our experienced team possesses a deep understanding of compendial requirements and employs state-of-the-art methodologies to deliver accurate and timely results. With a strong commitment to quality and regulatory compliance, we provide reliable support throughout the product lifecycle.

Related Topics
Drug Product Manufacturing
Laboratory Services
Biologics
Analytical Method Development
Contact Alcami
What do you want to know?
Some query