Method development and validation are critical throughout the drug life cycle. At different stages of generic drug development, the emphasis on analytical methods is different. We recommend that analytical methods be developed and validated (preverification) during the generic drug prescription process study phase.
Our Services
With a quality-by-design approach, our company provides analysis method development and validation services to ensure that quality, efficiency and regulatory requirements are met. For generic drugs with a pharmacopoeia-standard RLD, we aim to develop personalized detection methods for specific varieties and items. The content of different analysis methods is confirmed, including specificity, linearity, range, accuracy, repeatability, precision, detection limit, quantitation limit, and durability.
Shorten your R&D cycle and accelerate your generic program to market by developing robust, reproducible assays with our solutions. All of your manufacturing, quality control, and R&D activities are handled by Alfa Chemistry.
Types of Analysis Methods
Analyzing the quantity of API in a drug is an essential part of drug quality. We develop content analysis methods to meet the needs of generic drug prescription screening according to the specific project of customers. Our methods for content determination include titration, chromatography and spectral analysis.
The moisture content of drugs has a direct impact on the stability and shelf life of drugs, and has become one of the important indicators of drugs in the pharmacopoeia of various countries. Our company uses the Karl Fischer method to provide customers with accurate, precision, and high repeatability moisture detection method development services.
Microbial detection is crucial to drug quality control. Our company helps customers reduce R&D costs and risks through industry-leading testing platforms. We provide microbiological detection method development, method validation and sample testing services for pharmaceuticals.
The volatile organic chemicals that are used and produced during the manufacture of generic drugs are known as residual solvents. Residual solvents have varying requirements and different control strategies. Our company mainly uses gas chromatography to provide customers with residual solvent research and detection services in formulations, APIs, and excipients.
The purpose of cleaning verification is to demonstrate that product residues on the equipment surface can be effectively removed by cleaning procedures. If the residue does not meet the requirements, the cleaning protocol needs to be improved. Our company provides liquid chromatography based cleaning validation analytical method development, validation, and cleaning sample testing services.
The elemental impurities in the drug may produce toxic side effects and affect the effect of the drug. Most national pharmacopeias use ICH Q3D guidelines to control elemental impurities. Our company is equipped with industry-leading sample pretreatment and testing instruments, providing elemental impurity detection method development and validation services, and assisting enterprises to develop control strategies.
Since the enantiomers of chiral drugs may have completely opposite biological activities, research into chiral drugs is crucial to ensure the safety and effectiveness of drugs. Our company uses chromatography and optical rotation to accurately analyze chiral drugs.
Organic impurities in drugs are generally referred to as related substances. Our company uses a variety of methods such as chromatography to help customers study the relevant substances, and is committed to the development of high specificity, high sensitivity analysis methods.
Genotoxic impurities may cause carcinogenic side effects, and regulatory agencies in various countries require strict control. Our company has advanced instruments and rich experience in analytical method development, which can fully meet the needs of customers for the detection of genotoxic impurities.
Disintegrability determination is commonly required for readily soluble drugs. According to pharmacopeia standards, our company uses automatic disintegrators to measure the disintegration degree of generic drugs and RLD to help generic drug manufacturers rationally optimize the prescription process.
Our Capability
- The developed method has high specificity, high sensitivity and excellent reproducibility
- Meet ICH and Pharmacopoeia requirements
- Industry leading equipment and facilities and a professional technical team
- Laboratories that meet multiple system requirements
- Assess the risk of the project
- Complete, traceable reports
