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Company Profile

ALCHEMY is an Italian contract research company committed to providing comprehensive chemistry services to pharmaceutical, biotech and agrochemical companies as well as private and academic research institutes. Our staff consists of highly experienced and motivated synthetic and analytical chemists. Our goal is to maintain long-lasting relationships with our clients by providing efficient chemistry services and cost-effective solutions that meet our clients’ needs.

CUSTOM SYNTHESIS

Intermediates: ALCHEMY synthesizes intermediates of research compounds and pharmaceuticals. We will prepare the requested intermediates either by following known literature procedures or synthesis protocols provided by the client. If no route to the target compound is published, our experienced chemists will design the synthesis route for the preparation of the material themselves.

Reference compounds: ALCHEMY can synthesize and characterize reference compounds of APIs and pharmaceuticals in a timely and cost-effective manner.

Medicinal Chemistry, synthesis of NCE: ALCHEMY possesses all the required ingredients to support preclinical drug development from start to finish: modern laboratories and equipment for compound synthesis, isolation, and purification; state-of-the-art analytical instruments for compound characterization and purity determination; experienced and knowledgeable chemists with extensive industrial backgrounds in organic, medicinal, and analytical chemistry.

PROCESS DEVELOPMENT

ALCHEMY can rapidly develop scalable, robust and cost-effective chemical processes and optimize reaction conditions for intermediates or final products. Our PD services include:

• Evaluation, scouting and development of new synthesis for your target molecule
• Development of reliable analytical methods for process control
• Scale-up of new routes in glass reactors (5-10L)
• Impurity profile determination
• Continuous flow approach using microreactors

API IMPURITIES

Identification, quantification and qualification of impurities in API and formulated products is a 360 ° activity, deeply connected with Pharmaceutical production from R&D to final market release. ALCHEMY offers investigational services on drug impurities, specifically:

• Impurity identification
• Impurity isolation and synthesis
• Impurity quantification
• Residual solvents
• Degradation products studies

QUALITY CONTROL & ANALYTICAL SERVICES

A rich portfolio of analytical skills is the foundation of both internal Quality Control and Analytical Services, making Alchemy the ideal partner of the pharmaceutical industry for the development, validation and use of HPLC analytical methods in the analysis of active ingredients and other chemical substances.

State of the art instruments are in use in Quality Control of synthetic department: HPLC-MS, HPLC-DAD, UHPLC and FTIR.

Development of HPLC methods is carried out by means of a devoted last generation UHPLC. Analytical QbD and specific software are employed with the aim of complying with the incoming ICH Q14 guideline.

Validation of HPLC methods is performed according to the ICH Q2(R1) guideline.

Non-commercial standards for development and validation of HPLC methods are easily available to Alchemy S.r.l. thanks to the long experience in chemical synthesis. We can assist pharmaceutical industries in the identification of impurities “greater than identification threshold” and in the synthesis of impurities for qualification purposes, as described in ICHQ3A(R2).