Telephone : 080-28368181 / 82
Email ID: [email protected]
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
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PADM Provides the following services:
“One stop solution for your analytical needs”
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Generation and supply of Certified reference material.(Working Standards)
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Generation and supply of Certified Impurity standards
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Identification and characterization of Unknown Impurities
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Stability studies at cGMP environment
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Method Development and Validation as per ICH guidelines
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Synthetic R&D Services
Generation and supply of Certified reference material
(Working Standards)
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Standards are qualified using chromatography and spectroscopy
applications against to the Primary Reference standards (i.e., IP,BP,EP
and USP etc.,)
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Standards are provided along with proof of identity, documented
chromatographic purity and a batch-specific certificate of analysis.
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Easy ordering of Certified Reference Material through efficient and
user-friendly web interface.
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COAs and MSDS of Certified Reference Material availability on request
through web based interaction
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Updated catalogue of all the available Certified Reference Materials and
Rapid shipping of Certified Reference Material to the location with
appropriate storage conditions.
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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:
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FTIR
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HPLC
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LC-MS/MS
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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,
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Stability chambers
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Chamber 1. Accelerated : 40°C ± 2°C / 75% RH ± 5% RH
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Chamber 2. Intermediate: 30°C ± 2°C / 65% RH ± 5% RH
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Chamber 3. Long term :
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Chamber 4. Refrigerated condition: 5°C ± 3°C
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Photo stability study
25°C ± 2°C /60% RH ± 5% RH
Method Development and Validation
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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.
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Analytical Method development, validation and method transfer as per regulatory
requirements.
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Development and Validation of Analytical method: Dissolution by UV or HPLC
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Stability Indicating Assay and RS Methods by HPLC or LCMS or GC etc.,
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Development and Validation of Analytical method for estimation of residual solvents by
using GC.
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Development and Validation of Chiral Methods
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Finished Product Degradation profile.
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Comprehensive and comparative Physico-chemical evaluation of marketed products.
Synthetic R&D Services
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Synthesis and Identification of Novel Pharmacopoeial & Non Pharmacopoeial
Impurities.
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Synthesis and Characterisation of Unknown Impurities.
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Custom Synthesis, Route identification, Process Optimization (Organic
Intermediates).
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Synthesis of New Chemical Entities (NCEs).
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Micro Wave assisted Synthesis.
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Separation Techniques by Column Chromatography and Flash Chromatography.
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Process Development and Technology Transfer.
Synthetic R&D Capabilities
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We specially working on synthesis of Pharmacopoeial & Non Pharmacopoeial
impurities, New chemical entities (NCEs).
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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.
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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.
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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
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We are expertized in carrying out the organic reactions like,
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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
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We strictly follow stringent environment, health and safety norms.
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All products are developed and manufactured at in-house, adhering to the cGMP
Guidelines.
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