Telephone : 080-28368181 / 82 Email ID: info@padmlab. com Website: www Telephone : 080-28368181 / 82 Email ID: info@padmlab.com Website: www.padmlab.com

Company Profile PADM Laboratories Pvt Ltd., incorporated in January-2015, primarily focuses on generating high quality certified analytical standards (Certified Reference Material and Certified Impurity Standards), using state of the art analytical facilities. PADM quality systems are in compliance with cGMP, ICH guidelines and Pharmacopeial standards. We provide pharmaceutical analytical service for wide variety of developmental projects with an extensive range of fully qualified modern analytical equipments.

Company Profile PADM offers comprehensive stability studies expertise to our clients, assisting at every stage of the product development, commercialization and obtaining approval from regulatory authorities. We strive to provide high quality products and services with fastest turnaround time. PADM Laboratories Pvt.Ltd., support for the Synthetic R&D services in the field of Impurities, Pharma Intermediates, Product development & Technology transfer, catering to the changing needs of the pharmaceutical industry.

Our Services PADM Provides the following services: “One stop solution for your analytical needs” Generation and supply of Certified reference material.(Working Standards) Generation and supply of Certified Impurity standards Identification and characterization of Unknown Impurities Stability studies at cGMP environment Method Development and Validation as per ICH guidelines Synthetic R&D Services

Generation and supply of Certified reference material (Working Standards) Standards are qualified using chromatography and spectroscopy applications against to the Primary Reference standards (i.e., IP,BP,EP and USP etc.,) Standards are provided along with proof of identity, documented chromatographic purity and a batch-specific certificate of analysis. Easy ordering of Certified Reference Material through efficient and user-friendly web interface. COAs and MSDS of Certified Reference Material availability on request through web based interaction Updated catalogue of all the available Certified Reference Materials and Rapid shipping of Certified Reference Material to the location with appropriate storage conditions. Generation of Certified Reference Materials are in compliance with ISO Guide 34.

Supply of Certified Impurity Standards We supply Impurity Standards for exclusively for Pharma sector During synthesis of a chemical or a compound, impurities may be added to the substance, the characterization of impurities shall be performed with modern hyphenated techniques for specified properties, accompanied by a batch specific certificate of analysis. Customers shall be assisted with comprehensive reports and raw data (including chromatograms, spectras, and thermograms) for the above studies.

Identification and Characterization of Impurities We bring our expertise to identify the unknown impurities which are more than reporting threshold limit as per ICH guideline for drug substance and drug product. The identification and characterization of impurities shall be performed with modern hyphenated techniques like: FTIR HPLC LC-MS/MS NMR Customers shall be assisted with comprehensive reports and raw data (including chromatograms, spectra's, and thermograms) for the above studies. We will assist you in answering any queries from the regulatory bodies after submission of the data.

Stability Studies at cGMP environment We have state of the art facility for undertaking stability studies for APIs and finished dosage forms. These stability chambers are qualified as per cGMP requirement and ready for operation. The available stability conditions are, Stability chambers Chamber 1. Accelerated : 40°C ± 2°C / 75% RH ± 5% RH Chamber 2. Intermediate: 30°C ± 2°C / 65% RH ± 5% RH Chamber 3. Long term : 25°C ± 2°C /60% RH ± 5% RH Chamber 4. Refrigerated condition: 5°C ± 3°C Photo stability study

Method Development and Validation Developing analytical methods, workable throughout the life cycle of the product and ensuring high quality methods with low costs, without compromising on the separations for both drug substance and drug products. Analytical Method development, validation and method transfer as per regulatory requirements. Development and Validation of Analytical method: Dissolution by UV or HPLC Stability Indicating Assay and RS Methods by HPLC or LCMS or GC etc., Development and Validation of Analytical method for estimation of residual solvents by using GC. Development and Validation of Chiral Methods Finished Product Degradation profile. Comprehensive and comparative Physico-chemical evaluation of marketed products.

Synthetic R&D Services Synthesis and Identification of Novel Pharmacopoeial & Non Pharmacopoeial Impurities. Synthesis and Characterisation of Unknown Impurities. Custom Synthesis, Route identification, Process Optimization (Organic Intermediates). Synthesis of New Chemical Entities (NCEs). Micro Wave assisted Synthesis. Separation Techniques by Column Chromatography and Flash Chromatography. Process Development and Technology Transfer.

Synthetic R&D Capabilities We specially working on synthesis of Pharmacopoeial & Non Pharmacopoeial impurities, New chemical entities (NCEs). We undertake custom synthesis, contract research, product development and pharma intermediates from gm to kilogram scale with a state of the art in house R&D facilities to serve the scientific research community at highly competitive price. Our qualified staffs are expertise in literature search using search engines like STN, MDL, Patent search, Publications web like ACS, Science direct etc., and patent drafting. Our comprehensive product range, which continuous to grow through research and development expanding our product range by introducing new products in our chosen fields, namely, organic intermediates, protected amino acids, amino alcohol derivatives, small chain peptides and heterocyclic derivatives. 

Synthetic R&D Capabilities We are expertized in carrying out the organic reactions like, Grignard Reactions Buchwald/Suzuki Coupling n-Butyl lithium Reactions Cyclization Reactions Metal Hydride Reductions Catalytic Transfer Hydrogenation Hydrogenation Facility for Reduction Reactions Microwave Assisted Reactions Natural Product Isolation and Purification We strictly follow stringent environment, health and safety norms. All products are developed and manufactured at in-house, adhering to the cGMP Guidelines.