Services

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Analytical Chemistry Service

After a compound is synthesized, it needs to be analyzed quantitatively and qualitatively, structurally distinct, purified, and chemically characterized utilizing cutting-edge methods and tools. Our company offers its customers a comprehensive selection of high-caliber analytical chemistry services that are delivered quickly. We can swiftly discover and assess chemicals in our analytical testing laboratories thanks to our innovative approach. We can effectively communicate the results of those assessments to our customers so they can better understand the chemistry of their products.

Service Overview

Our company provides high quality analytical testing services to help the drug marketing and development process. We comply with global pharmaceutical regulatory requirements, and our laboratory is equipped with several high-end precision instruments including NMR spectroscopy, mass spectrometry, IR spectroscopy, single-crystal X-ray diffraction, thermogravimetric analyzer (TGA), differential scanning calorimetry (DSC), inductively coupled plasma source mass spectrometer (ICP-MS), etc. In addition, our analytical chemistry team is highly recognized by our customers for its experience and skilled problem-solving.

Main Services

Our company provides you with a full range of pharmaceutical analysis services, including but not limited to:

Method Development and Method Validation

API method development and validation (according to Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, ICH, and other special requirements of customers)
Residual solvent method development and validation (according to US Pharmacopoeia, European Pharmacopoeia, ICH, etc.).

Analytical Testing and Release

Determination of compound structure and configuration confirmation.
Analytical support for drug R&D and cleaning verification.
Appearance, dissolution and microbial testing, and more.

Structural identification of impurities or degradation products.
Detections of leachable/extractable.

Drug Impurity Analysis

Separation and monitoring of impurities in starting materials, intermediates, APIs and pharmaceutical products using HPLC and other techniques.
Collection of complete 1D/2D NMR, LCMS, EA, HRMS, IR, UV and other data to identify the structure of isolated impurities.
Isolation and structural identification of API-forced degradation products.
Rapid determination of raw materials, intermediates, APIs and synthetic impurities using quantitative nuclear magnetic resonance (QNMR).

Stability Study

Experimental / exploratory stability study.
Stability study for global drugs registrations.
Stability study of drugs after approval for market.

Microbiological Testing

Method development, method validation and testing of microbial and bacterial endotoxin for APIs and different types of pharmaceutical preparations.

Physical and Chemical Studies

Characterization of physical and chemical properties.
Structural analysis and solid-state characterization.

More Services

Our company is well positioned to provide comprehensive analytical chemistry services for drug research. Please contact us to learn more.

Analytical and Testing Lists

For the aforementioned services and more needs of customers, Our company can provide the following specific analytical and testing items which are divided into five broad categories.

Physical and Chemical Testing Items	Appearance, moisture, acidity, residue on ignition (ROI), polymorphism, loss on drying (LOD), particle size distribution (PSD), hygroscopicity, specific rotation, melting point, solution color and clarity, solubility, impurity detection, thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), infrared spectroscopy (IR), ultraviolet spectrum (UV), NMR analysis, etc.
Chromatographic Testing Items	Ion chromatography (IC), gas chromatography (GC), high performance liquid chromatography (HPLC), GC-MS/MS, LC-MS/MS, ICP-MS, gel permeation chromatography (GPC), etc.
Testing Items for Drug Formulations	Osmotic pressure, specific gravity, buffer capacity, surface tension, water loss rate and leakage, dissolution rate, viscosity, fluidity, Log P, Log D, pKa, Zeta potential, bulk density, tap density, dissolution behavior of drug in artificial intestinal juice, dissolution behavior of drug in artificial gastric juice, etc.
Featured Testing Items	Microbial detection, endotoxin detection, single strain detection, residual oxygen analysis, in vivo release test (IVRT), in vitro release test (IVPT), rheology study, particle size and particle size distribution, water activity, deliverable volume, aerodynamic particle size distribution (APSD), droplet size distribution, etc.
Special Service Items	Impurity preparation and separation, high throughput purification services, chiral resolution, structure identification and structure analysis, safety assessment (RC1, ARC, T_D24), potential genotoxic impurity (PGI) screening, stability study (real time testing, accelerated testing, retained sample testing, cyclic temperature stress testing), proportion analysis of excipients, in vitro phosphate-binding studies, in vitro bile salts binding studies, in vitro BSA protein binding test, in vitro pepsin activity inhibition test, in vitro BE method development and validation, in vitro BE statistical analysis and determination, etc.
At Our company, for all the testing items, we provide original images and raw data, and a complete experimental report including experimental materials, experimental procedures, and experimental results.

Our company focuses on providing high-quality pharmaceutical analytical chemistry services. And we are committed to providing our customers with efficient and reliable solutions that meet their specific needs and create maximum value for them. If you are interested in our services or have any questions or needs, please feel free to contact us. We will be happy to provide you with support and services.

It should be noted that our service is only used for research, not for clinical use.

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