Pharmaceutical Products Development

Pharmaceutical Formulation Development

At PharmaPrimes Laboratories, we specialize in developing robust pharmaceutical formulations across a wide range of dosage forms, including tablets, capsules, injectables, and topical products. Our comprehensive services are designed to optimize drug delivery and efficacy, ensuring your product stands out in the market.

Our Services Include:

Dosage Formulation: Tailored development strategies for optimized drug delivery systems, enhancing bioavailability and patient compliance.
Process Development and Optimization: From lab-scale prototypes to commercial-scale production, we ensure seamless technology transfer and scalability, optimizing processes for efficiency and cost-effectiveness.
Analytical Method Development and Validation: Comprehensive development and validation of analytical methods to ensure accurate and reliable quality control throughout the product lifecycle.
Regulatory Support: Assistance with regulatory documentation and compliance to meet global standards, including FDA and EMA guidelines.

Pharmaceutical Product Testing

We offer an extensive range of testing services to ensure the safety, efficacy, and quality of your pharmaceutical products. Our state-of-the-art facilities are equipped with advanced instrumentation and staffed by experienced professionals committed to excellence.

Our Testing Services Include:

Stability Testing: Comprehensive evaluation of the shelf life and optimal storage conditions of drug products under various environmental conditions, following ICH guidelines.
Impurity Profiling and Degradation Studies: Identification and quantification of impurities and degradation products that may arise during manufacturing or storage, ensuring product safety and compliance.
Dissolution and Release Testing: Assessment of drug release profiles in various dosage forms to ensure consistent performance and bioavailability.
Microbiological Testing: Including sterility testing, microbial limits, and endotoxin testing to ensure product safety.
Physicochemical Characterization: Detailed analysis of physical and chemical properties critical to product performance.

Our testing protocols adhere strictly to GMP, GLP, and ISO standards, ensuring data integrity and regulatory compliance.

Nitrosamines Testing Services

Nitrosamines are potential carcinogens that have gained significant regulatory attention due to their presence in various pharmaceutical products. At PharmaPrimes Laboratories, we offer comprehensive Nitrosamines Testing services to ensure your products meet the stringent safety standards set by global regulatory agencies.

Our Capabilities Include:

Ultra-Sensitive Detection: Utilizing advanced analytical techniques such as LC-MS/MS and GC-MS/MS, we can detect and quantify nitrosamines at ultra-trace levels (parts-per-trillion, ppt), surpassing regulatory requirements.
Regulatory Compliance: Our testing methods comply with FDA, EMA, and ICH M7 guidelines, providing you with reliable data for regulatory submissions.
Method Development and Validation: Customized analytical methods tailored to your specific products, ensuring accurate detection of all relevant nitrosamine impurities.
Risk Assessment and Consultation: Expert guidance on nitrosamine risk assessments, control strategies, and mitigation plans to proactively address regulatory concerns.

Identification of Unknown Compounds

Identifying unknown compounds, impurities, or degradation products in pharmaceutical substances is critical for ensuring product safety and regulatory compliance. PharmaPrimes Laboratories offers comprehensive identification services using cutting-edge analytical technologies.

Our Expertise Includes:

High-Resolution Mass Spectrometry (HR-MS): For precise molecular weight determination and structural elucidation.
Nuclear Magnetic Resonance (NMR) Spectroscopy: Providing detailed molecular structure information to confirm compound identities.
Advanced Chromatography Techniques: Including HPLC, UPLC, and GC-MS for efficient separation, isolation, and analysis of complex mixtures.
Fourier Transform Infrared (FTIR) Spectroscopy: For functional group identification and material characterization.
Elemental Analysis: Determination of elemental composition to support structural analysis.

Our team of seasoned scientists is adept at tackling even the most challenging identification tasks, ensuring that all potential impurities or degradation products are accurately detected and characterized. We provide detailed reports and support for regulatory submissions, helping you maintain compliance and product integrity.