Drug products and drug substances such as raw materials and excipients testing are carried out routinely as per the latest pharmacopoeia (IP, BP, EP, USP) or Customer In- House procedures and specifications. Our capability to perform analysis of Raw Material/APIs/Bulk substance, Intermediates and Excipient testing as per Pharmacopeia Monograph. Our pharmaceutical testing service includes:

• Raw Materials/API’s/Bulk Drugs, excipients, Intermediates and In-process sample Analysis done by as per standard specifications such as IP, BP, EP, USP or Customer In- House procedures and specifications.
• we carry out identification tests, Assay, impurity, trace metals, Related substance, Dissolution, Content uniformity, Residual solvents, Particle size distribution, etc.,
• We ensure accuracy and reliability of test results within Turn-Around-Time.

• In-vitro Dissolution testing for pharmaceutical products has important role in drug development and is used in all phases of development. The pharmaceutical products which have low systemic absorption, In Vitro binding studies are considered.
• It is key analytical test used for detecting physical changes in an active pharmaceutical ingredient (API) and in the formulated product.
• In vitro dissolution testing is a useful factor to estimate the In-Vivo performance of drug products and potentially reduce the number of bioavailability / bioequivalence (BA/BE) studies required.
• Our In-vitro dissolution study services carried out for Bulk drugs, finished products and other dosage forms as per requirements according to pharmacopoeias or customer requirements, Development and validation of dissolution studies.

• We carry out Heavy/trace metal analysis of raw material, drug substances and drug products by highly sophisticated instrument ICP-MS.
• We perform method development and validation by ICP-MS.

• Analytical method development and validation is an essential component of any pharmaceutical development program using suitable technique for the qualitative and quantitative estimation through the establishment of product specification and its shelf life.
• We established validated test methods by verifying the process with understandable limitations of application so that the minor difference between operators or between laboratories does not have an impact on results.
• Our analytical method development and validation services performed as per ICH guidelines or customer requirements.
• Our Method development carry out identification tests, Assay, impurity, trace metals, Related substance, Dissolution, Content uniformity, Residual solvents, Particle size distribution, etc.,
• We used analytical Techniques with sophisticated equipment’s such as HPLC (UV, RI, FLD, PDA), GC-HS (FID, ECD), GC-MS/MS, LC-MS/MS, ICP-MS.
• Our capability to perform analytical method development and validation testing on Active Pharmaceutical Ingredients (APIs) / Bulk drugs/Drug Substance and Intermediates, Finished Formulation Drug Products with different dosage forms such as Tablets, Capsules, Injectable, Syrups, etc.,

• In pharmaceuticals impurities may originate from several sources in the manufacturing process. Impurities into drug product resulting from elements intentionally added (e.g., catalysts), potentially present in the drug substance/ water/ excipients, introduced from manufacturing equipment, leached from container closure systems.
• Impurity analysis is done according to ICH, or customer requirements.
• We have extensive analytical infrastructure capable of supporting our customer requirements technically sound, reliable, compliant with quick turnaround time.
• We used ICP-MS analytical Technique and samples are processed by microwave digestion system for impurity studies.
• Our capability to perform Impurity testing on Active Pharmaceutical Ingredients (APIs) / Drug Substance/Bulk drugs, Intermediates and Excipients, Finished Formulation Drug Products with different dosage forms.

• We perform Qualitative and quantitative analysis of extractable and Leachable using HPLC, LC-MS / MS, GC-MS / MS, ICP-MS, IC etc.,
• Our analytical service carried out
• Packaging material assessment and development.
• Identification and quantification of known & unknown compounds.
• Method development, optimization and validation of controlled extractable study for routine control of container closure system.
• Evaluations of results for toxins from the container closures system.
• We perform extractable and leachable testing on Primary Containers, Auxiliary Articles and Manufacturing Aids used for various drug products such as Solids, Parental, Injectable Containers (HDPE, LDPE, PP), Plastic bags, Rubber stoppers, Glass vials, Syringes, Resins, Injectable bags / vials, Blister packs, etc.,

• We provide physical characterization services including polymorph characterization, oxidative and thermal analysis, spectroscopic analysis and particle size determination, Surface Area Analysis as per customer requirements.
• Techniques used are pXRD, SEM, DSC, particle size analyser, Melting Point Apparatus, FTIR, Refractometer etc.,

• We perform Packaging material testing services according to the various regulatory guidelines and recommendations.
• Techniques used are GC-MS/MS, HS-GC, LC-MS/MS, ICP-MS, IC, SEM.
• We perform Packaging material testing on Primary Containers, Auxiliary Articles and Manufacturing Aids used for various drug products such as Solids, Parental, Injectable Containers (HDPE, LDPE, PP), Plastic bags, Rubber stoppers, Glass vials, Syringes, Resins, Injectable bags / vials, Blister packs, etc.,

• Testing the presence of micro-organisms in pharmaceutical products is a vital requirement to protect public health and fulfill with regulatory requirements.
• Testing the presence of micro-organisms in pharmaceutical products is a vital requirement to protect public health and fulfill with regulatory requirements.
• Our capability to perform microbiological testing on Active Pharmaceutical Ingredients (APIs) / Drug Substance/Bulk drugs, Intermediates, Excipients, Finished Formulation Drug Products with different dosage forms and Pharmaceutical Water.

Our microbiological testing services provides

• Microbial Limit Tests (MLT)
• TSterility Test
• Microbiological Assays
• Bacterial Endotoxin Test (LAL)
• Antimicrobial Effectiveness of Preservative Efficacy Test (AET/PET)
• Environmental Monitoring (Air Microbial quality evaluation) by Settle plate method and Active Air Sampler
• Media Growth Promotion Test (GPT)
• Disinfectant Efficacy Test
• Water system validations

• we offer wide-ranging Pharmaceutical Grade Water testing as per standard Specifications.
• We provide water testing include physical and chemical analysis, pesticide residues, Heavy/Trace metal analysis and microbiological analysis.
• We perform analysis as per BIS standards IS 10500:2012 Drinking water, Water for Pharmaceutical Purposes, Inlet & Outlet Water Analysis, Purified water analysis, Microbiological Analysis etc.,

• Veterinary Drug Analysis done by as per standard specifications such as IP, BP, EP, USP or Customer In-House procedures and specifications.
• We carry out identification tests, Assay, purity and strength, Related substance, Dissolution, Content uniformity, etc., as per pharmacopoeia standards.
• We ensure truth and reliability of test results within Turn-Around-Time.
• Our capability to perform analysis on Active Pharmaceutical Ingredients (APIs) / Bulk drugs/Drug Substance Finished Formulation Drug Products with different dosage forms such as Tablets, Capsules, Injectable, Powders, Syrups, etc.,