Analytical method development and validation is required to determine performance characteristics for the intended analytical application. Depending on performance characteristics, the validation parameters may change. In general, we follow ICH, FDA, and USP guidelines for methods validation.

We have a senior-level technical team that is dedicated to performing method development and method validation services. Our technical team has years of experience working on stability-indicating methods, residual solvent methods, dissolution methods, and specific and non-specific cleaning validation methods. We have our own protocols that comply with ICH and FDA guidelines, or we follow client-supplied protocols. We offer Method Development and validation services using a wide range of technologies including PSD, ICP, HPLC, UV, and GC. We have extensive experience in HPLC & GC method development and validation. We use these analytical techniques to develop and validate methods for APIs, intermediates, raw materials, and finished products.

IRLPL has years of experience performing all types of Analytical tests on many drug substances, drug products and medical devices. We assure our clients with highest level of quality and attention that their analytical method development and validation projects are successfully executed. Our experience covers the spectrum of pharmaceutical development phase I, II and III.

• IRLPL has an experienced team capable to lead the process from protocol design to storage, monitoring, analytical testing, and documentation.
• A complete range of storage conditions in multiple climatic chambers.
• The stability units have operational back-ups and are fully controlled with 24×7 monitoring and alert systems.
• Customer-specific conditions can also be accommodated.
• Long term and Stress conditions (accelerated); Drug products, and drug substance intermediates hold-time study.

• The careful assessment of interactions between drug products and their container closure systems and manufacturing process contact material is crucial for the compliance and safety of pharmaceutical and biopharmaceutical products. It is imperative that each drug application filing provides comprehensive data to prove the safety and suitability of the proposed container closure systems for their intended use.
• As per cGMP regulatory requirements (21 CFR Part 211.94 (a)), drug product containers and closures must not be reactive, additive, or absorptive in a way that would change the safety, identity, strength, quality, or purity beyond the official or established requirements. This underscores the need to assess drug products for potential chemical contaminants or impurities that could arise during manufacturing or storage, a process carried out through extractable and leachable studies.
• Drawing on over three decades of experience in E&L testing, VIMTA stands as a pioneering and highly preferred testing partner in this specialized field. Our cutting-edge laboratories are furnished with LCMS/MS, GCMS, and ICPMS technologies, enabling precise identification of chemical compounds that may leach from the product during usage. At Intervein, we provide tailored protocol-driven E&L testing services to help guarantee that your product complies with relevant regulatory requirements and is safe for patients. Our adept scientific team has conducted over 2000 E&L studies across various product categories and possesses comprehensive knowledge of applicable standards and regulatory stipulations. The data from our studies has been submitted to, and well received by, US and European regulatory authorities.

Furthermore, our packaging material expertise covers an array of components, including:

• – Rubber stoppers – EPDM packaging
• – Gaskets & O-rings – Inhalation devices
• – Prefilled syringes – Glass vials
• – Syringes – Resins
• – Injectable bags/vials – Films, blister packs
• – Laminated tubes – Tubing & filters
• – Large volume containers – Disposables (Bioprocess – single use)
• – HDPE, LDPE, PP, Plastic bags & containers – In-process manufacturing components

Our product experience includes but is not limited to:

• Inhalations
• Ophthalmic
• Parenteral, Injectables
• Oral vaccines
• Topicals
• Dermal Patches
• Implants
• Solid dosage forms

Method development, validation and routine testing for elemental impurities in raw materials, excipients, APIs and finished products.

Why choose elemental impurities testing from IRLPL?

We offer guidance throughout the entire process, from identifying elements to determining limits.

We help determine if quantitative or qualitative testing is needed, whether to test APIs or finished drug products, and assist in managing challenges from EP, USP, and ICH Q3D.

Additionally, we define required impurities and limits for testing, offer customized screening for elemental impurities, and provide solid risk assessments where additional data is needed.

We can also assist with combining drug products and setting specifications for addition type testing over a range.

Being a global leader in analytical chemistry services, we possess the professional expertise and regulatory qualifications needed to conduct method development, method validation, and routine testing for all your elemental impurities requirements. With extensive experience in compendia proposed methodology, our highly qualified staff is always updated on the evolving requirements and are ready to implement new testing.

We provide:

• Multiple locations across Europe, Asia and USA
• Instruments, including ICP-OES & ICP-MS.
• Closed vessel microwave digestion
• Experience with overcoming interferences (physical, chemical, spectral, isobaric, polyatomic)
• Long-time experience in method development and validation
• Verification of Pharmacopeia methods
• Experience with a huge variety of different sample types and complex sample matrices

Get in touch with IRLPL today to discover how our expertise in elemental impurities can assist you in meeting regulatory requirements.

• We offer unrivaled expertise in residual impurity testing and analysis for biopharmaceuticals, backed by our global network and regulatory knowledge.
• At Intervein, all residual solvent studies are performed in accordance with defined USP Residual Solvents <467> method.
• We provide a comprehensive range of advanced chromatography and mass spectrometry instrumentation, coupled with extensive method development expertise, to optimize analytical methods for impurity analysis. The optimized method can be validated as a limit test or through full ICH Q2(R1) validation in compliance with GMP standards.
• To find out more about our process related impurities analysis services, contact us today.

• In Vitro Release Test (IVRT) (In vitro drug release through artificial membranes) and In Vitro Permeation Test (IVPT) (drug penetration into porcine/ cadaver skin) are valuable tools to evaluate the product quality and performance of semisolid topical drug products.
• In vitro release testing (IVRT) is used to monitor the release and diffusion of drug substances from semisolid dosage forms.

Why partner with us?

– Dedicated team with in-depth expertise to handle the FDC Instruments for IVRT / IVPT studies.

– Established infrastructure to conduct the IVRT / IVPT studies.

– All activities will be captured as per the requirement of regulatory agency FDA / EMA.

– Ability to rectify challenges for such a complex study procedure.

Our Experience

–   In vitro Staff having experience of Successfully completed and submitted  twenty one IVRT studies and eleven IVPT studies to FDA regulatory, Having Experience of Molecules like Acyclovir Cream, Dapsone Gel, Tacrolimus Ointment,Penciclovir Cream, Azelaic Acid Cream, Lidocain, Diclofenac, Acyclovir and Hydrocortisone,Crisaborole, Adapline gel, Clindamycin, Doxepin

Franz diffusion cell

• It is used for release evaluation of semi-solids formulation
• The most common IVRT method employs an open chamber design like the Franz diffusion cell system and can be used with a synthetic membrane, a tissue construct, or biological sample, such as cadaver skin. The membrane separates the donor compartment containing the test product from the receptor compartment filled with collection medium.

Intervein Research Labs which is USFDA approved analytical services provider from Ahmedabad, Gujarat India.

• Following the identification of nitrosamines in pharmaceutical products, the US Food and Drug Administration (US FDA) and the European Medical Agency (EMA) have released specific requirements and limitations for nitrosamine contaminants.
• We have the capability to detect nitrosamine impurities in your pharmaceutical products, verify compliance, and guarantee both product and patient safety.
• We specialize in developing customized test methods, based on LC-MSMS, to detect the presence of nitrosamine traces in drug products, raw materials, and active pharmaceutical ingredients (APIs) at recommended LOD/LOQ levels and specifications.
• Our methods are capable of simultaneous screening of multiple nitrosamines within the same sample or can be applied as targeted analyses for one or two specific contaminants. The use of cold-labeled internal standards ensures highly accurate quantitation even in the most complex matrices.

Nitrosamine impurities testing enables you to:

• Regulatory agencies strongly advise all manufacturers and providers to conduct thorough product testing in order to safeguard patients and to implement robust measures to prevent impurities from occurring in medications.
• Detecting and measuring nitrosamine residues in drug products, raw materials, active pharmaceutical ingredients (APIs), and packaging is vital for ensuring the safety of our products and safeguarding the well-being of patients.
• This testing is indispensable for validating regulatory compliance and refining extraction methods to achieve the necessary levels of Limit of Detection (LOD) and Limit of Quantitation (LOQ) in drug products.
• Moreover, it entails conducting method development, transfer, validation, and batch release to maintain superior quality standards.

• In the manufacturing process, the residues of the Active Pharmaceutical Ingredient can adhere to the equipment even after cleaning, potentially impacting the quality of subsequent production cycles. Equipment contamination from cleaning agents like detergents or solvents is also a concern. Therefore, it is imperative to ensure that the processing equipment is free of potential contaminants and suitable for pharmaceutical manufacturing.
• Validation of the cleaning method is essential to ensure that it effectively eliminates not only residues of the API but also other potential contaminants such as degradation products and residues from the cleaning processes.

WHAT ARE EXCIPIENTS?

An excipient is a crucial substance that is deliberately formulated alongside the active ingredient of a medication. It serves the purposes of ensuring long-term stabilization, bulking up solid formulations containing potent active ingredients in small amounts (often referred to as “bulking agents”, “fillers”, or “diluents”), or conferring a therapeutic enhancement on the active ingredient in the final dosage form. This can include facilitating drug absorption, reducing viscosity, or enhancing solubility.

Excipients play a vital role in the manufacturing process by assisting in the handling of the active substance, such as facilitating powder flowability or providing non-stick properties. They also aid in in vitro stability, preventing denaturation or aggregation over the expected shelf life.

The choice of suitable excipients is dependent on the route of administration and the dosage form, as well as the active ingredient and other relevant factors.

LAB TESTING OF EXCIPIENTS

• Excipients are an indispensable part of pharmaceutical formulations, working in tandem with active pharmaceutical ingredients (APIs) to enhance stability, shelf life, and control drug release.
• The absorption rate of dosage form pharmaceuticals is pivotal in determining their ability to dissolve and deliver pharmacological effects within the body.

ROLE OF EXCIPIENTS TESTING

• Excipients, though technically inactive, play a crucial role in pharmaceuticals and are a major component of the final product. Testing is essential to understand how excipients affect drug absorption and optimize formulations for desired therapeutic effects. Some excipients slow drug dissolution to prevent tissue damage, while others disintegrate rapidly for quick symptom relief.
• Gel permeation chromatography (GPC) is commonly used to test polymeric excipients, but a flexible approach is needed due to the wide variety of available excipients.