Zhongxi is a complete laboratory for analysis and testing, also an audited contract laboratory.We can provide a wide range of chemical analysis and material testing services to a diverse international customer base.Our expertise and years of experience enable us to choose the right analytical methods and generate the accurate data needed to solve your toughest problems.
Our analytical method development team produces accurate and reliable methods that deliver consistent results. If you need experienced method development chemists to measure the concentration of an active pharmaceutical ingredient (API) in a specific compounded dosage form, Zhongxi can help. If you need to identify and quantify the excipients, intermediates, raw materials, preservatives, antioxidants, impurities and more within a formulation, we can ensure that your product maintains the proper identity, purity, potency, and performance.
There are many reasons why you may need to develop and validate methods for quantifying your functional ingredients. Examples include:-
-Using new raw materials or recipes
-The need to comply with new and relevant legislation
-Claim substantiation
-Changes to the manufacturing process or analytical procedures.
Method Validation in Pharmaceutical Analysis
Beyond method development, our skilled method validation chemists can verify existing methods to help ensure approval of regulatory submissions. Our team can also improve upon existing methods by identifying gaps and proposing a detailed remediation plan. This can even include tailoring existing test methods to your drug substance or drug product, which can save on both time and cost in developing an analytical method. Our contract research lab can even take on difficult LC-MS method validations and complex ELISA assays. Our experienced staff can develop methods for even the most complex formulations within your timeframe. We develop custom proposals to complete the analyses you require when certifying a new drug product or amending a current drug application.
If you have a method development or validation project that cannot be done in-house due to its complexity, or you need the work completed on a tighter schedule than your in-house laboratory can handle, Zhongxi can help. As development partners, we can design detailed protocols for method development, validation, and technology transfer based on the product’s phase in the drug development process.
What Necessitates the Development of Analytical Methods During Drug Development?
-Lack of methods in any pharmacopeias for a particular drug or drug combination
-Existing procedures require expensive reagents or solvents, require highly complex extraction or ·derivatization procedures, or may not be reliable
Analytical Method Development & Validation Protocols for Raw Materials & Finished Products Including:
-Pharmaceutical Ingredients (API’s), Drug Formulations, Nutraceuticals & Biopharmaceuticals
-Immediate & Modified Release Formulations
-Polymers & Coatings
-Small & Large Molecules
-Cosmetic & Personal Care Products
-Raw Materials
Multiple Dosage Forms Supported:
-Injectables (Lyo & Non-Lyo)
-Solids, Semi-Solids & Liquids
-Inhalation/Nasal
-Transdermal & Suppository
Our scientists develop custom Method Development and Validation protocols based on established guidelines. All methods are tested under strict internal and external requirements, we can develop methods for:
● Custom Assay Development
● Potency & Purity Methods
● Complex Method Validation
-Accuracy & Recovery
-Precision (Test/Re-Test Reliability & Intermediate Precision)
-Specificity & Selectivity
-Limit of Detection (LOD)
-Limit of Quantitation (LOQ)
-Linearity & Range
-Samples Stability in Matrix
-Stock Solutions Stability
-Specificity
-Homogeneity
-Ruggedness
-Robustness
Method Development & Validation Studies for:
| ● Characterization of Drug Substances | ● Pharmacokinetic, Bioavailability & Bioequivalence | ● Method Transfer & Training |
| ● Analytical Standard Characterization | ● Release Testing & Evaluation | ● Formulation Development |
| ● Reference Standard Qualification | ● Drug Excipient Compatibility Studies | ● Product Deformulation |
| ● Active Assay & Related Substances | ● IND Phase-Appropriate Method Validation | ● Comparative Studies |
| ● Gap Analysis & Remedial Validation | ● Process Impurity | ● Vendor Qualification |
| ● Extractables & Leachables | ● Chromatographic & Chiral Purity | ● USP Method Testing |
| ● Solubility & Solution Stability Studies | ● Residual Solvents Analysis | ● ELISA Assay |
| ● Stability Indicating Assays | ● Peak Identification | ● Column Equivalency Studies |
| ● Prototype Evaluation – Accelerated/Stress Studies | ● Cleaning Procedures Validation | ● Technical Consulting |
| ● Forced Degradation Studies | ● Cleaning Residual Assays | ● Counterfeit Product Evaluation |
| ● Dissolution Testing | ● Process Validation & Remediation Support | ● Material Contact Studies |
| ● Preservative Assays | ● Physical Methods | ● Method Life-Cycle Evaluation Studies |
| ● reservative & Stabilizing Excipients Assays | ● Nasal Spray Characterization | ● Lyophilization Cycle Design (DSC) |
| ● Polymer Identification (FTIR or NMR) | ● Particulate Identification | ● Low-level Genotoxic Impurities |
Analytical Techniques Utilized
Techniques commonly utilized include GC/MS, GC, AA Spectrophotometry, UV/Visible spectroscopy, ICP-MS, and HPLC. Our standard analytical method development, validation, or transfer services report includes a copy of the analytical method, copy of all test results and protocols, appropriate calculations and graphs, and our instruments’ raw data.
For more information about our services or technical advice, please fill out this form and we will get back to you as soon as possible.Our professional engineer will reply to you immediately.