Analytical Testing
At Laxus Labs, we understand that precision, accuracy, and reliability are critical in analytical testing. With cutting-edge technology and a team of experts, we provide comprehensive testing solutions tailored to meet the diverse needs of industries such as pharmaceuticals, food, and environmental sciences. From identifying impurities to ensuring compliance with global regulatory standards, our analytical testing services are designed to help you achieve the highest quality benchmarks.
Our laboratories are equipped with advanced instrumentation and operate under stringent quality control protocols. With decades of experience and a commitment to innovation, we ensure that every analysis delivers actionable insights and supports the success of your product or process.
- Analysis of raw materials, intermediates, active pharmaceutical ingredients (APIs) and Finished dosage forms (Tablets/Capsules/Semi Solids/ Injectables)
- Active Pharmaceutical Ingredients (API)
- Intermediates
- Excipients
- Key starting materials (KSM)
- Analysis of Excipients
- Analysis of Elemental Impurities
- State-of-the-art technologies utilized, including X-ray Diffraction,
- Fourier Transform Infrared Spectroscopy
- Malvern Particle Size analyser
- Surface Area Analyser.
- Thermo Gravimetric Analysis .
- Differential Scanning Calorimetry and Modulated DSC
- Ability to detect trace elements down to minute quantities of part per billion (ppb)
- Inductively Coupled Plasma Mass Spectrometry
- Ion Chromatography
- Atomic Absorption Spectroscopy
- Ability to detect Genotoxic Impurities (GTIs) & Nitrosamines down to minute quantities of part per billion
- Liquid Chromatography-Tandem Mass Spectrometry
- Liquid Chromatography-High-Resolution Mass Spectrometry
- Gas Chromatography-Tandem Mass Spectrometry
- Extractable and leachable (E&L) studies are essential to detect and quantify potential contaminants that may migrate from container closure systems (CCS), pharmaceutical processing equipment, or medical device packaging, ensuring drug product safety and efficacy.
- Comprehensive E&L study design and execution is carried out in compliance with regulatory guidelines, including USFDA (USP <1663> & <1664>), ICH, and specific client requirements.
- A full-service E&L testing program helps meet regulatory standards while safeguarding product quality.
- CCS selection and evaluation are conducted for various dosage forms and medical devices.
- Analytical techniques such as GC-MS/MS, HS-GC-MS, LC-MS, ICP-MS, and Soxhlet extraction are used for precise sample analysis.
- Testing is performed on a wide range of container closure systems, including HDPE, LDPE, PP containers, plastic bags, rubber stoppers, gaskets, O-rings, glass vials, prefilled syringes, injectables, laminated tubes, tubing, and filters.
- Critical packaging materials, secondary components, and manufacturing aids used in various drug formulations—such as solids, parenterals, injectables, ointments, syrups, suspensions, gels, creams, and emulsions—are thoroughly analyzed.
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Setting the Standard for Analytical Excellence
Our approach to analytical testing goes beyond producing results—we provide data you can trust. By working closely with clients, we ensure a deep understanding of their requirements, enabling us to deliver tailored solutions that drive innovation and improve outcomes. Our commitment to precision and compliance ensures that your products meet industry regulations while maintaining the highest levels of safety and quality.
Partnering with Laxus Labs means gaining access to expertise, state-of-the-art facilities, and a customer-centric team that prioritizes your success. From routine testing to complex analyses, we strive to be your trusted partner for all analytical testing needs.
Method validation and development must be completed to determine the performance characteristics required for the intended analytical application. Depending on these characteristics, the validation parameters may vary. Typically, we adhere to ICH, FDA, and USP guidelines for method validation.
Laxus Labs is home to a senior-level technical team that specializes in method development and ICH method validation services. With years of experience, our team has expertise in developing stability-indicating methods, residual solvent methods, dissolution methods, and specific and non-specific cleaning validation methods. We have developed our own protocols, in line with ICH and FDA guidelines, though we are also capable of following client-provided protocols. We offer both pharmaceutical method development services and USP method validation services. Our capabilities extend to a variety of technologies such as PSD, ICP, HPLC, UV, and GC. Our technical team is well-versed in HPLC method development, HPLC validation, GC method development, and GC validation. These techniques are employed to develop and validate methods for APIs, intermediates, raw materials, and finished products. After each project, we provide a comprehensive report that includes a detailed step-by-step method.
- Precision
- Intermediate Precision and Ruggedness
- Linearity
- Accuracy
- Range
- Forced Degradation Studies
- Limit of Detection/Limit of Quantification
- Stability of Standard and Sample Solutions
- Photo stability study
- Robustness
With extensive experience, Laxus Labs has handled a variety of analytical tests across drug substances, products, and medical devices. We guarantee that each analytical method development and validation project is conducted with the highest standards of quality and attention. Our experience spans all phases of pharmaceutical development (Phase I, II, and III).
Medical devices
Parenterals
Raw materials
GC/MS
ICP-MS
Do we need prescription for these testing?
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How much time it takes for report delivery?
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