Analytical Method Development Services in Thane (एनालिटिकल मेथड डेवलपमेंट की सेवाएं, ठाणे)

Analytical Method Development Validation Service

Development of HPLC methods for Assay, Blend Uniformity, C.U, Dissolution, Related substances Residual Solvents, T.L.C for DP/DS.Development of new short run, robust method by UHPLC for Assay, Related substance and Dissolution.Convert existing HPLC method to UHPLC method thereby increasing the throughput of the existing method without disturbing the elution pattern.Development of discriminating, biorelevant and release medias for dissolution test of different dosage forms like IR, CR, SR Tablets/Capsules/Suspensions/OS.Developing diffusion methods for ophthalmic suspensions, nano emulsions.Reverse Engineering/ Deformulation Studies of RLD products.

Nalanda research Laboratories is developing analytical methods by considering the customer & regulatory requirements. And validate the analytical methods as per ICH guideline Q2(R1) with following parameters. For Identification test, the method validation is carried with System suitability and Specificity.For Quantitation test method for impurities, the minimum parameters are Specificity, Linearity, Precision (repeatability & Intermediate), Accuracy, Range, Detection Limit, Quantitation Limit, Robustness & System Suitability. For Quantitation test method for Assay, the minimum parameters are Specificity, Linearity, Precision (repeatability & Intermediate), Accuracy, Range, Robustness & System Suitability.

Analytical Method Development Service

Analytical Method Development Services

Analytical Method Development Services

Analytical Method Development Services

Analytical Method Development

We undertake method validation of new substances. The activities include in-process analysis, identification and quantification of impurities.

Analytical Method Development Service

We provide analytical method development for a broad spectrum of pharmaceutical compounds and dosage forms during various drug development stages, including methods for different types of compounds. Stability-indicating assay and/or related substances methods for drug substance and drug products (tablets, capsules, suspensions, creams, injectable, nasal sprays, pMDIs, medicated feeds, drug-eluting stents, etc.) Dissolution (IR, ER, MR) Organic volatile impurities Preservatives and antioxidants Enantiomer separation Clinical comparator assay and dissolution Cleaning validation on various surfaces by HPLC, UV and GC Dose verification for GLP studies The analytical development group also provides method development experimental design interim progress reports for method development. Additionally we can support your analytical research, validation, and investigation requirements.

Our dedicated team of experts and equipment capabilities safeguard to deliver quality analytical methods throughout early phase clinical research to GMP scale up/commercialisation in line with ICH and FDA/MHRA requirements. Our technical team develop, qualify, validate and transfer analytical methods with a custom-made quality control approach. This enables full analytical support for RSM and in-process control strategies in addition to characterisation and development flexibility in the context of process development and GMP manufacturing for a drug candidate. Method development, qualification, validation, and transfer in compliance with global regulatory guidelines/ICH Q2(R1) ICH stability including photostability Forced degradation studies Impurity isolation, identification, and characterisation. Characterisation of APIs and precursors Reference material program cGMP Regulatory Starting Material assessment PGTi nitasoamine assessment and testing

Analytical Method Development

Analytical Method Development Services

Analytical Method Development department has qualified & well equipped chemists who can undertake work as per ICH guidelines. Indoco is working with few US/ European clients for development of analytical methods for their products. A few contracts have been completed already by delivering/ compiling data and services to the satisfaction of the customers.

We provide analytical and documentation support for a wide variety of product development programmes

Formulation development Analytical method development and validation Stability evaluation and analysis as per ICH guidelines In-vitro equivalence and Dissolution studies Process validation Technology transfer API source evaluation Preparation, Compilation and Submission of reports in CTD/eCTD format

Method Validation by various Analytical Techniques

Herbal Method Development

Method Development And Validations

As per the latest regulatory requirements, a stability indicating method for analysis is a must. We develop methods that are suitable for the intended purpose. Developing methods for Assay content, Estimation of impurities and degradation products, In-vitro profiling are Analytical Solutions specialties

Analytical Method Development Services

Analytical Method Development Service

Analytical method validation

Analytical Method Development

Analytical Method Development Services

Analytical Method Development Services

Analytical Methods Development