Oral Thin Film Analysis and Testing Services

An oral thin film is a flat, edible films used to deliver APIs orally or through oral mucosa, which is becoming increasingly popular due to its numerous advantages. Reliable analytical testing is an essential part of the production process of high-quality oral thin films. CD Formulation provides powerful analytical testing services for oral thin films development project to ensure that oral thin films meet regulatory requirements and required quality standards.

The Importance of Oral Thin Film Analysis and Testing Services

The establishment of analytical methods and testing play an important role in the development process of oral thin films, as it determines whether the drug is safe and meets regulatory requirements and ensures final drug quality. For drug development companies, understanding the physical and chemical properties of the drugs being produced is essential to ensure drug candidates successfully undergo the pre-formulation, formulation, and commercial manufacturing processes to ensure drug quality and compliance with regulatory requirements. Therefore, it is very important to create a standard and robust set of experimental test methods to perform analysis and testing procedures for target ingredients.

Explore Our Oral Thin Film Analysis and Testing Services

As a leader in the development of new drug delivery systems, CD Formulation has decades of experience in analysis method and testing of oral thin films, and has the most advanced testing instruments in the industry to meet various testing requirements, whether you want to analyze candidate raw materials and packaging materials or want to analyze existing products or reverse analysis, we can provide you with comprehensive, innovative and timely solutions. Our team of experts continually evaluates and expands our testing capabilities to meet our customers' growing needs. Our services include but are not limited to:

Analytical Method Development and Validation for Oral Thin Film

Analytical method development and validation are not only the key to the approval of drug clinical research, but also to ensure the quality and efficacy of drug development and manufacturing and is a key link that cannot be ignored to ensure the safety of drug use for patients. We provide a series of analytical method development and validation services for your oral thin film development, including precision (repeatability and intermediate precision), accuracy, detection limits, quantitative limits, etc.

Release Testing for Oral Thin Film

For the quality control of oral thin films, in addition to the same routine inspection items as ordinary oral preparations, special physical, chemical, mechanical, and other properties should be evaluated according to the characteristics of the dosage form to ensure the safety and effectiveness of the product. Release testing is essential to ensure the quality, safety, and effectiveness of drugs before they are marketed. We provide a full suite of analytical techniques to evaluate your APIs and finished products, including but not limited to ICH stability testing, dissolution and disintegration testing, moisture analysis, viscosity analysis, etc.

Stability Testing for Oral Thin Film

The purpose of the stability testing is to examine how the content of raw materials and their preparations changes with time under the influence of temperature, humidity, and light, to provide a scientific basis for the production, packaging, storage, and transportation conditions of the drug, and to predict the validity period of the drug. CD Formulation provides complete stability testing services for Oral thin films. Our teams are experienced in handling stability study projects, including all logistical and regulatory requirements, and all work from sample receipt, shipment and reporting are performed in a GMP approved stability study center. We operate to the highest quality standards, offering flexible solutions to satisfy all types of clients while also providing a cost-effective service.

Our Oral Thin Film Analytical and Testing Capabilities

• Nuclear magnetic resonance spectroscopy (NMR)
• Gas Chromatography (GC)
• High-performance liquid chromatography (HPLC)
• Ultra-performance liquid chromatography (UPLC)
• Gas Chromatography/Mass Spectrometry (GC/MS)
• Ultraviolet/visible spectrum (UV/VIS)
• Fourier Transform Infrared (FTIR)
• Differential Scanning Calorimeter (DSC)
• Scanning Electron Microscopy (SEM)
• Texture Analyzer
• Gel permeation chromatography (GPC)
• High performance liquid chromatography/mass spectrometry (HPLC/MS)
• Ultra-performance liquid chromatography/mass spectrometry (UPLC/MS)
• Inductively Coupled Plasma Spectroscopy (ICP)
• Laser diffraction (LD) analysis
• Differential scanning calorimetry (DSC）
• In vitro dissolution
• Karl Fischer

Our Advantages in Oral Thin Film Analysis and Testing

• Flexible: Our professional teams have extensive experience and expertise to tailor analytical solutions to suit project needs and provide accurate and reliable results and solutions.
• Professional: We provide professional analytical method development and testing services to help you obtain accurate analytical results in a short time, accelerate your oral thin film drugs development process, save time and cost.
• Compliance with Regulatory Requirements: We provide GMP analytical testing services to help you carry out rigorous quality control and conformity verification to ensure that your oral thin films meet regulatory requirements.
• On-Time Delivery: We will deliver satisfactory results to you within the agreed time.
• Complete Documentation: We provide clear, complete analytical method development reports.

In oral thin films development process, whether you need help with method development, validation, impurity analysis or stability testing, we can provide you with specialized technical support to simplify your drugs development program, save you time and money, and accelerate your oral thin film drugs to market. If you have a requirement about our oral thin film analysis and testing services, please contact us by phone or email, our colleagues will reply to you within three working days.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.