Pharmaceutical Testing
Pharmaceutical testing is a key means of ensuring the safety and efficacy of drugs. Through rigorous testing, the ingredients, dosage, and quality of the drugs can be verified, ensuring their safety and effectiveness in clinical use. For example, stability testing can assess a drug's performance under different environmental conditions, thereby determining its storage conditions and expiration date, which ensures the safety and efficacy of medication for patients.
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Scope of Pharmaceutical Testing Services
- Testing of Active Pharmaceutical Ingredients (APIs) and Excipients
- Quality Analysis of Finished Pharmaceuticals
- Impurity Analysis and Toxicity Studies
- Microbial Limit Testing
- Dissolution Testing
- Stability Analysis
- Packaging Material Compatibility Analysis
Testing of Active Pharmaceutical Ingredients (APIs) and Excipients
Testing of active pharmaceutical ingredients (APIs) and excipients is a critical aspect of the pharmaceutical industry, involving several areas, including the determination of the physicochemical properties of APIs, the selection and compatibility studies of excipients, impurity control, and stability testing.
- Structural Identification (NMR, MS, IR)
- Purity Testing (HPLC, GC)
- Impurity Analysis (LC-MS/MS)
- Elemental Analysis (ICP-MS)
Quality Analysis of Finished Pharmaceuticals
Quality analysis of finished pharmaceuticals is a key process to ensure that drugs maintain stability and comply with quality standards during production, storage, and use. It encompasses chemical, physical, and microbiological testing to ensure the safety, efficacy, and compliance of drugs.
- Determination of Active Ingredient Content (HPLC, UV-Vis)
- Disintegration, Dissolution, and Uniformity Testing (Pharmacopeia Methods)
- Analysis of Physicochemical Indicators such as pH, Moisture, and Viscosity
Impurity Analysis and Toxicity Studies
Impurity analysis is crucial for ensuring the safety and efficacy of drugs. Impurities can affect the drug's efficacy, stability, toxicity, and bioavailability. Therefore, impurity analysis not only helps assess drug quality but also provides essential data for safety evaluations.
- Organic Impurities (ICH Q3A/Q3B Standards)
- Inorganic Impurities (USP<232>/<233>)
- Residual Solvents (GC-HS)
- Degradation Product Analysis (Forced Degradation Studies)
Microbial Limit Testing
Microbial limit testing is a critical process in drug manufacturing used to assess and control the microbial contamination levels of drugs and their raw materials and excipients. Through testing, it ensures that drugs comply with microbial contamination control requirements during production, storage, and transport, thereby safeguarding patient safety.
- Bacterial, Fungal, and Yeast Limits Inspection
- Sterility Testing (Compliant with USP<71>)
- Endotoxin Testing (LAL Method)
Dissolution Testing
Dissolution testing is an in vitro test used to evaluate the rate and extent at which a drug is released from dosage forms such as tablets, capsules, and ointments into a solvent. This process simulates the gastrointestinal environment to predict the drug's performance in the body. Dissolution testing is not only used for quality control but also for new drug development, formulation optimization, and quality assurance during the commercialization process.
Stability Analysis
Drug stability analysis is crucial for ensuring the quality, efficacy, and safety of medications. It not only affects the production, packaging, storage, and transportation conditions of drugs but also directly relates to their shelf life and patient safety. The data from drug stability analysis can provide scientific evidence for scaling up drug production, batch release, and market launch.
Packaging Material Compatibility Analysis
Compatibility of pharmaceutical packaging materials refers to the absence of unacceptable interactions between the packaging materials and the drugs, ensuring the efficacy and safety of the pharmaceuticals. Such interactions may include chemical reactions, physical changes, or biological responses that could lead to a decline in drug quality or safety risks.
- Extractables and Leachables (E&L) Analysis
- Safety Testing of Glass Containers and Plastic Packaging
Looking for Popular Pharmaceutical Testing Services?
Popular pharmaceutical testing services include potency testing, stability testing, and deformulation.
Need Expert Pharmaceutical Testing Standards?
ICH
ICH is an international organization initiated by the European Union, the United States, and Japan, aimed at harmonizing global technical requirements for drug registration to ensure the safety, efficacy, and quality of pharmaceuticals. ICH standards cover various aspects, including quality, safety, and efficacy, serving as an important reference for drug registration worldwide. For example, the ICH Q series guidelines detail quality control, stability testing, clinical trial design, and other aspects of the drug manufacturing process.
USP (United States Pharmacopeia)
USP is a set of internationally recognized quality standards for pharmaceuticals established by the United States Pharmacopeial Convention, widely used in the global pharmaceutical market. USP standards provide detailed analytical methods and acceptance criteria for quality control, ensuring the quality and safety of pharmaceuticals throughout the production and distribution processes.
EP (European Pharmacopoeia)
EP is a set of quality standards for pharmaceuticals established by the European Medicines Agency (EMA), complementing USP and ICH standards. EP standards hold significant importance in global drug registration, particularly among EU member states.
JP (Japanese Pharmacopoeia)
JP is a set of quality standards for pharmaceuticals established by the Japanese Pharmacopoeia Council, applicable to the Japanese market. JP standards align with ICH and USP standards in many respects, ensuring mutual recognition of pharmaceuticals on a global scale.
FDA (U.S. Food and Drug Administration)
FDA is the primary agency responsible for drug registration and regulation in the United States. FDA standards are mainly implemented through Drug Master Files (DMF) and Good Manufacturing Practice (GMP) certification. The FDA has strict registration requirements for active pharmaceutical ingredients and finished products to ensure their safety and efficacy.
Why Choose Us?
Advanced Testing Equipment
We are equipped with a variety of high-end testing instruments, including High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), Gas Chromatography-Mass Spectrometry (GC-MS), Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Scanning Electron Microscopy (SEM), X-ray Diffraction (XRD), and more. These devices have wide applications in the pharmaceutical, biotechnology, and medical device industries, providing high-precision and high-sensitivity analytical results to ensure the accuracy and reliability of data.
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Experienced Pharmaceutical Testing Expert Team
Our team consists of several senior scientists and technical experts with extensive expertise in pharmacology, pharmacokinetics, pharmacodynamics, and toxicology. Team members not only possess rich theoretical knowledge but also have accumulated a wealth of practical experience, enabling them to handle complex samples and testing requirements and provide scientifically sound solutions for our clients.
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Customized Testing Solutions
We offer personalized service plans based on the specific needs of our clients, ensuring that their products comply with regulatory requirements. Our testing services cover the entire lifecycle from active pharmaceutical ingredients to finished products, including quality control, stability studies, and methodological research. Through a strict quality control system and high standards of laboratory construction, we can provide our clients with efficient and precise testing services.
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Advanced Testing Equipment
Experienced Pharmaceutical Testing Expert Team
Customized Testing Solutions
How Does our Pharmaceutical Testing Process?
Communication Consultation
Clients communicate with Alfa Chemistry's technical staff to clarify testing requirements, sample volume, testing cycle, and quotation information.
Signing Agreement
After confirming the testing requirements, both parties sign a confidentiality agreement to protect the client's privacy and data security.
Sample Submission
Clients submit samples to the testing agency according to the agreed method (via courier or in-person).
Experimental Arrangement
After receiving the samples, Alfa Chemistry arranges the experiments and calculates the testing cycle.
Invoice Issuance
Before the experiments begin, clients must pay the relevant fees, and Alfa Chemistry will issue an invoice.
Report Issuance
Upon completion of the experiments, Alfa Chemistry issues a formal testing report and sends it to the client via email or in printed form.
After-Sales Consultation
If clients have any questions, they can contact Alfa Chemistry's technical staff for consultation.
Curious About Our Success Stories?
Here are two case studies showcasing pharmaceutical testing services conducted for other companies, highlighting the value and impact of our expertise.
Case 1: Impurity Testing of APIs for a Large Pharmaceutical Company
A large pharmaceutical company needed to comply with the ICH Q3A, USP, and EP regulations for organic impurities, inorganic impurities, and residual solvents when declaring an anti-infection API for export. However, during internal quality testing, it was found that some batches contained unknown impurities exceeding the limits, affecting the product's international registration approval.
Testing Plan and Implementation
- Method Development and Validation
- HPLC-UV was used for routine organic impurity testing, and LC-MS was combined for structural analysis of unknown impurities.
- ICP-MS was employed to analyze inorganic element impurities, such as lead (Pb), cadmium (Cd), arsenic (As), and mercury (Hg), ensuring compliance with USP<232>/<233>requirements.
- GC-HS (Gas Chromatography-Headspace Sampling) was used to detect residual solvents, in accordance with USP<467>standards.
- Methodological validation was conducted to ensure the accuracy, precision, and repeatability of the testing methods.
- Experimental Analysis and Results
- An unknown degradation impurity exceeding the limit was detected in a specific batch, which was hypothesized to be an oxidative degradation product after LC-MS analysis.
- Stability testing (ICH Q1A) revealed that the generation of this impurity was related to excessively high storage humidity.
- After optimizing the production process (reducing oxidant residues and optimizing drying conditions), the impurity levels were reduced to within regulatory limits.
- Customer Benefits
- The issue of API impurity exceeding limits was resolved, allowing the product to successfully pass international registration approval (FDA/EMA).
- A detailed impurity profile analysis report was provided to help the company optimize its production process and improve product stability.
Case 2: Formulation Development Support for an Emerging Pharmaceutical Company
An emerging pharmaceutical company was developing a sustained-release oral solid formulation, aiming to meet the FDA requirements for in vitro dissolution curves while enhancing the formulation's bioavailability. However, during the formulation screening stage, the company found that the dissolution rate of the formulation was unstable, making it difficult to control drug release behavior.
Testing Plan and Implementation
- Formulation Optimization Support
- HPLC was used to establish a dissolution analysis method, and methodological validation was conducted (ICH Q2).
- In vitro dissolution testing (USP<711>) was performed to investigate the effect of different excipient ratios on drug release behavior.
- DSC (Differential Scanning Calorimetry) and XRD (X-ray Diffraction) were used to analyze the compatibility of the drug with excipients, optimizing the formulation design.
- Key Analytical Data and Adjustments
- It was found that the type of disintegrant in the formulation significantly affected dissolution behavior; after adjusting the type of disintegrant, the dissolution curve became stable.
- Laser particle size analysis was used to optimize the particle size distribution of the formulation powder, improving solubility and uniformity.
- Accelerated stability testing (40°C/75% RH, 6 months) was conducted to ensure the product maintained consistent dissolution characteristics during the storage period.
- Customer Benefits
- Helped the company identify and resolve the instability issue with the dissolution rate during the formulation optimization phase.
- Ensured the in vitro dissolution curve met FDA requirements, increasing the success rate of subsequent clinical trials.
- Accelerated the new drug development process, reducing unnecessary testing costs and enhancing market competitiveness.
What Our Clients Say
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