Neugen Labs has extensive experience in Analytical Method Development, Method Validation, Method Transfer. Method development is the process of proving that an analytical method is acceptable for use in our laboratory to measure the concentration of an API in a specific compounded dosage form.
For established pharmaceutical preparations, which are not new drug species analytical method process can be much simpler. Majority of analytical methods
Developed are by using volatile buffers which facilitate the structure elucidation LC- MS studies .Modern analytical instrumentation, like high performance chromatography with versatile detectors such as the ultraviolet, photodiode
Spectrometer (HPLC- PDA), allow simplified procedures to be employed to verify that an analysis procedure accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation.
- METHOD DEVELOPMENT
- METHOD VALIDATION
- STABILITY STUDIES
- STRUCTURE ELUCIDATION
- ANALYTICAL TESTING
Full method development procedures are complex, extended, and expensive endeavors. These studies are usually required when data from the analysis is going to be submitted to regulatory authorities for certification of a new or amended drug application. The analytical method is tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantitation limit and robustness.
Regulatory agencies expect to see some level of validation for non-compendial methods. Whether your submission is an IND, NDA, IMPD, MAA, CTA, ANDA we can provide the appropriate level of validation for test methods in your CMC section. All relevant guidelines such as the ICH guidelines are followed
We typically validate test methods for API, drug products, and drug product containers. The usual validation process involves a validation protocol that is signed by both the client and Neugen Labs. We complete the laboratory work in agreement with the protocol made for the test method that is being validated.
We can summarize validation results in the final version of the test method and/or describe the results in details in a stand-alone validation report.
Some typical test method validation parameters are ruggedness, linearity and range, limit of detection and quantitation, accuracy, precision, specificity, robustness and solution stability
We provide stability testing on Drug products specially during development an surveillance study. Our stability operations have extensive storage capacity for all ICH conditions as well as custom storage conditions. Our stability chambers are continuously monitored through a computer database system and are on generator back-up.
CORE TESTING AND ANALYSIS EXPERTISE
R&D preliminary studies, finished product, API’s, high throughput QC stability and release testing, comparator studies and additional capabilities for photo stability studies.
All stability studies are performed in accordance with the ICH Q1A-Q1F guidelines. We develop stability Indicating Methods and made use of those while performing stability studies for APIs and Drug products.
Stability ovens walk -in Chambers and analytical instruments are fully qualified. Computerized Laboratory instruments are 21CFR part 11 compliant.
Neugen Labs Analytics offers a broad spectrum of structural analytical methods, taking in everything from high-field NMR spectroscopy to single crystal X-ray diffractometry. In addition to structural elucidation for R&D issues, we also focus on the reliable identification of materials and end products and the elucidation of unknown secondary components.
In the area of pharmaceutical analytics, we validate calibration substances under GMP conditions. We work through complex issues step-by-step and offer a number of fixed price packages for this purpose. .For those looking to perform evaluations themselves, we provide spectra in the form of raw data (e.g.FID).
We employ chromatographic combination methods, particularly LC/MS and GC/MS, for the direct investigation of substance blends. In this case, high-resolution mass spectrometry enables unambiguous structural assignments. Our portfolio for structural analytics is rounded off by quantitative analysis, e.g. Using NMR.
Neugen Labs makes uses of state-of-the-art methods and technologies carrying advantages
MOST DETAILED STRUCTURAL INFORMATION
Through our combined high-end analytical methods, we have access to the I structural resolution power! In consultation with our client, we establish the most efficient approach and define a detailed work-plan with clearly identified milestones
Neugen Labs microbiologists and chemists have been at the fore front of safety science for decades. Our analytical testing services help manufacturers and retailers confirm that products-from food and drugs to chemicals, household goods and toys-perform according to specifications and meet international standards.
Neugen Labs analytical testing services offer a full range of material testing analysis aimed at discovering impurities in raw materials/finished products and confirming product label claims.
- Ultraviolet light(UV)
- Gas chromatography-mass spectrometry(GC-MS)
- High-performance liquid chromatography(HPLC)
- Ultra performance liquid chromatography (UPLC)
- Fourier transform infrared spectroscopy(FTIR)
- Inductively coupled plasma (ICP )
- Inductively coupled plasma mass spectrometry(ICP-MS)
With analytical chemistry capabilities that cover a wide range of instrumental and classical wet chemistry techniques, Neugen Labs analytical testing services provide solutions to problems within the field of material science. Based on recognized international standards, our analytical chemical testing helps promote consumer safety through regulatory compliance.
NEW DRUG DELIVERY SYSTEM
Our approach to NDDS centers around development of novel nanolipoidal carrier systems made up of unique bio friendly biomaterials like Phospholipids in conjunction with other promising excipients like hydrocolloids and polymers. It is expected that the resulting vehicle will improve delivery enabling the active ingredients more effective in lower doses while minimizing the chances for toxicity or side effects.
The patient compliance is the additional benefits. This strategy has a huge potential in giving a new life to old molecules. New product thus developed will find applications in dermatology cosmetics and nutraceuticals.
Our working approach is comprehensive in nature and aimed on the theme ’Concept of Commercialization‘. Hence forth, it covers all the directions and dimensions of scale up, technology development and commercialization, through collaborations with various academic, government and industry partnerships.
Chemical synthesis is an essential part of drug development. However, the number of technical and managerial tasks involved in the process-many of which prove to be“ one- off” operation — can cause to hamper the overall effectiveness of the research team. Outsourcing the activity to a specialist custom synthesis lab is an efficient, cost-effective means of ensuring the smooth and timely passage of new drug compounds through pipeline and expanding the basket throughout sourced libraries. We can offer services on project basis or on FTEs.
- CUSTOM SYNTHESIS
- REFERENCE STANDARDS
- DEUTERATED COMPOUNDS