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ANALYTICAL METHOD VALIDATION STUDIES

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We undertake method validation studies as per ICH guidelines. This includes analytical method validation of compendial and non compendial chromatographic method. We also undertake project for analytical method development and validation for cleaning procedures.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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POLYMORPHIC SCREENING EVALUATION

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Anacipher helps in the determination of physico-chemical properties such as solubility with respect to temperature and pH, dissociation constant and partition coefficient, polymorphic screening evaluation, polymorph qualification and hygroscopicty.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Polymorph & Crystal Screening

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DETERMINATION OF HYGROSCOPICTY

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Determination of physic-chemical properties as follows: Solubility with respect to temperature and pH, dissociation constant and partition coefficient, polymorphic evaluation and hygroscopicty.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Moisture Sorption

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DISSOCIATION CONSTANT & PARTITION COEFFICIENT

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Determination of physic-chemical properties as follows: Solubility with respect to temperature and pH, dissociation constant and partition coefficient, polymorphic evaluation and hygroscopicty.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: pKa and LogP

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LC-MS METHOD DEVELOPMENT

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We undertake development of critical parameters or methods, such as analytical method to determine impurities, which don't have chromophores and hence don't have detection, Chiral method development, LC-MS suitable method development.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass Spectrometry and LC / MS

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METHOD DEVELOPMENT FOR PARTICLE SIZE ANALYSIS

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We undertake development of critical parameters or methods, such as method development for particle size analysis and polymorph quantification by XRD.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Particle Size

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CHIRAL METHOD DEVELOPMENT

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We undertake development of critical parameters or methods, such as analytical method to determine impurities, which don't have chromophores and hence don't have detection, Chiral method development, LC-MS suitable method development.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Chiral HPLC & SFC Method Development

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SCALE UP

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Kilo Lab is for the production of gram to several kilogram quantities of NCE's, key intermediates and API's, Indoco Kilo Lab is a modern, state-of-the-art facility with all Equipments conforming to cGMP and GEP norms. Dedicated Multi product facility to manufacture API's from 100 to 2000

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Pharma Service: API Manufacturing

Category: Scale Up

Sub Category: Overview

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HIGH PRESSURE REACTION FACILITY

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Indoco Kilolab is a modern, state-of-the-art facility with all Equipments conforming to cGMP and GEP norms, has High pressure reaction facility and Huber System for Reactions -60°C to 200°C.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: High Pressure Reactions (> 100 psi)

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GMP FOR INTERMEDIATE & API

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Indoco Kilo Lab is a modern, state-of-the-art facility with all Equipments conforming to cGMP and GEP norms. Design to meet cGMP, EDQM and USFDA standards

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Pharma Service: API Manufacturing

Category: GMP Manufacturing

Sub Category: Overview

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MANUFACTURING ADVANCE INTERMEDIATE

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Indoco Kilo Lab facility is versatile to perform a wide variety of reactions and complete multi-stage intermediate and API processes. Multipurpose facility to manufacture Advance Intermediate for Rest of World markets.

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Pharma Service: API Manufacturing

Category: Fine Chemical / Intermediate

Sub Category: Overview

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MICROBIOLOGICAL TESTING

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Indoco Kilolab is a modern, state-of-the-art facility with all Equipments conforming to cGMP and GEP norms. Standalone Quality Control, Instrumentation & Microbiological testing .

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Microbiology

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ANALYTICAL METHOD DEVELOPMENT

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We undertake complete analytical project development activities for formulation as well as API products. This includes analytical method development for RMs, Intermediates, Inprocess and finished product in line with regulatory requirements.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Overview

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SYNTHESIS OF KNOWN / UNKNOWN IMPURITIES

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With the help of deep organic chemistry knowledge along with state-of-the-art synthesis infrastructure, Anacipher offers synthesis services for known / unknown impurities.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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IMPURITIES STUDY

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Impurities of Drug products, API and intermediates can be studied. Impurities and degradation of products can be studied and unknown impurities can be identified by means of LC-MS and LC-MS-MS analysis. Specified impurity contained within the sample can be isolated, purified and identified.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

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REFERENCE STANDARDS AND IMPURITIES

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Reference standards / working standards of impurities & products can be qualified & characterized with a complete report for regulatory submission. Anacipher helps in in-house impurity standard generation by means of degradation & isolation or synthesis.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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GENOTOXIC EVALUATION

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Genotoxicity of the impurity can be evaluated based on FDA approved software. It offers genotoxic and Potential extractable and leachables studies and stablishment of Specification and acceptance criteria

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Toxicological Risk Assessment (TRA)

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EXTRACTABLE & LEACHABLES

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Extractable and Leachables (both organic and inorganic) study in drug product. It offers development and validation of analytical methods, study stability sample for establishment of leachables maximum level, and qualification of extractable and leachables.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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DRUG EXCIPIENT COMPATIBILITY STUDIES

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The drug - excipient compatibility can be studied by subjecting the binary mixtures of drug with different excipients to the differential scanning calorimetric analysis.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Excipient Screening

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STEREOCHEMICAL STABILITY

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We help in stereochemical stability, chemical and physical stability of polymorphs, and structure elucidation based on LC/MS and chemistry.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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CHEMICAL & PHYSICAL STABILITY OF POLYMORPHS

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We help in stereochemical stability, chemical and physical stability of polymorphs, and structure elucidation based on LC/MS and chemistry.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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STRUCTURE ELUCIDATION BASED ON LC/MS & CHEMISTRY

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We help in stereochemical stability, chemical and physical stability of polymorphs, and structure elucidation based on LC/MS and chemistry.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Structure Elucidation

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CHROMATOGRAPHIC METHOD DEVELOPMENT & VALIDATION

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We have extensive experience in chromatographic method development and validation including reverse phase, normal phase and Chiral HPLC methods and Head space GC methods. We have expertise in spectroscopic, titrimetric and particle size analysis methods development and method validations.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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CLEANING VALIDATION

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We also develop and validate analytical methods for cleaning validation. Method validation will be performed using procedures according to current guidelines or customer's specification. We also offer on-site method transfers into our customer's lab by well trained lab stuff.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)

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POLYMORPHISM STUDIES

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Following is the list of studies that can be performed at our laboratory for polymorphism: morphology, identification of polymorph, evaluation of Polymorph for Patent, euantification of Polymorph, percentage crystallinity, equilibrium solubility of the Polymorph.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Polymorph & Crystal Screening

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LYOPHILIZATION STUDIES

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Lyophilization studies can be performed to establish isolation procedures of thermally unstable drugs, lipid, enzymes etc. We offer these services up to laboratory scales.

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Pharma Service: API Manufacturing

Category: Lyophilization

Sub Category: Overview

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TRACE ANALYSIS & CARRY OVER STUDIES

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Trace analysis of impurities like organic, inorganic and residual solvents and their carry over in the finished product can be performed as per regulatory requirements. The report with suitability of the method along with the limits of detection and quantification.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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RESIDUAL SOLVENTS

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Trace analysis of impurities like organic, inorganic and residual solvents and their carry over in the finished product can be performed as per regulatory requirements. The report with suitability of the method along with the limits of detection and quantification.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Residual Solvents

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API CUSTOM SYNTHESIS

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Synthetic Labs are supported by expert team of scientist in handling mg to Kg scale Reactions, adequate Utility Services, hygienic Environment, cryogenic & High pressure Reaction Facilities and separate Laboratories for CRAMS and Generic Research.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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NON-INFRINGING SYNTHETIC ROUTES

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Synthetic Labs are supported by expert team of scientist in handling mg to Kg scale Reactions, adequate Utility Services, hygienic Environment, cryogenic & High pressure Reaction Facilities and separate Laboratories for CRAMS and Generic Research.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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CHIRAL SYNTHESIS

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We offer Chiral Synthesis, Chiral Separation and synthesis of chiral compounds like ACE inhibitors.

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Pharma Service: API Manufacturing

Category: Chiral Synthesis

Sub Category: Overview

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CRYOGENIC REACTION FACILITIES

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Synthetic Labs are supported by expert team of scientist in handling mg to Kg scale Reactions, adequate Utility Services, hygienic Environment, cryogenic & High pressure Reaction Facilities and separate Laboratories for CRAMS and Generic Research.

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Pharma Service: API Manufacturing

Category: Low Temperature / Cryogenic conditions

Sub Category: Overview

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ORGANOMETALLIC REACTIONS

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Synthetic Labs are supported by a team of scientists for handling mg to Kg scale reactions, adequate utility services, hygienic environment, cryogenic & high pressure manufacturing facilities and separate laboratories for CRAMS and generic research.

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Pharma Service: API Manufacturing

Category: Organometallic Chemistry

Sub Category: Overview

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HYDROGENATION

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Synthetic Labs are supported by expert team of scientist in handling mg to Kg scale Reactions, adequate Utility Services, hygienic Environment, cryogenic & High pressure Reaction Facilities and separate Laboratories for CRAMS and Generic Research.

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Pharma Service: API Manufacturing

Category: Hydrogenation

Sub Category: Overview

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