Analytical Method Development

  • 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.

Analytical Method Validation

  • Analytical Method Validation as per ICH/ US FDA guidelines for DP/DS.
  • The validation of following tests are carried out :
    • Elemental Impurities by ICP
    • Polymorphs by XRD
    • Particle Size by Malvern
    • Assay, RS, Dissolution by HPLC
    • Residual Solvent by GC-HS
    • RS by TLC
    • Assay by Potentiometer
    • Identification by FT-IR
  • Forced Degradation studies of drug substances & drug product
  • Analytical Method Transfer for drug substance/drug products to the production site.
  • AMVR, AMTR as per the regulatory standard.

Forced Degradation Studies

  • Forced Degradation studies of drug substances & drug product as per ICH guidelines.
  • To determine the stability indicating nature of assay and related substances methods.
  • Establishment of degradation pathways and reaction mechanisms to evaluate the intrinsic stability of the product.
  • Identification and Determination of degradation products/Impurities using hyphenated techniques.

Technology Transfer

  • Transfer of analytical procedures (TAP) with documented processes (AMTP and AMTR) to qualify a laboratory (the receiving unit) to use an analytical test procedure for intended purpose.
  • Comparative testing analysis on predetermined samples for qualifying the receiving laboratory.
  • Covalidation between two or more laboratories for determining the reproducibility of the testing methods.

Reverse Engineering

Reverse Engineering of Innovator Products for quantification of Inactive ingredients

  • Quantification of excipients in ophthalmic products.
  • Simultaneous determination of cations, anions and active ingredients in a single run.
  • Quantification of salts like Na, K, Ca in active ingredient.
  • Alternative technology for Ion Chromatography in reverse engineering studies.

Extractable & Leachable Studies

Testing of Extractable & Leachables impurities from Packaging Material.

  • Material Selection and Early Assessment
  • Evaluation of Organic Extractables
  • Evaluation of Inorganic Extractables
  • Routine Control of Organic Extractables
  • Evaluation of Leachables
  • Safety Assessment of Extractables and Leachables

Dissolution Method Development

  • Development of bio-relevant dissolution method for IR, CR, ER, MD tablets, capsules and suspension.
    • Determining Solubility and Stability of Drug Substance in Various Media at 37°.
    • Choosing a Medium and Volume
    • Choosing an Apparatus
    • Effect of Deaeration
    • Effect of Sinkers
    • Effect of Agitation
    • Determing f2 similarity factor in the comparison of dissolution profiles
    • Performing Filter Compatibility using cannula filters, filter disks or frits, filter tips, or syringe filters
  • Development of dissolution method for ophthalmic suspension
  • Development of Multimedia dissolution method

Genotoxic Impurities

  • Determination of Genotoxic and Carcinogenic Impurities in Drug Substances and Products by hyphenated techniques like GC-MS/MS
  • Development of analytical methods for determining Genotoxic and carcinogenic impurities.
  • Validation and Technology transfer of the Genotoxic and carcinogenic impurities..

Residual Solvents

  • Development of GC methods for determining Residual Solvents in DP/DS.
  • Validation and technology transfer of analytical methods.
  • Determining level of Class1, Class2, Class3 solvents in batches.

Stability studies

Stability testing of new drug substances & products as per ICH guidelines.

  • Evaluation for Retest Period or Shelf Life Estimation for Drug Substances or Products Intended for Storage Below Room Temperature
  • Photostability Testing of New Drug Substances and Products.
  • Evaluation of container closure system for primary and secondary packaging.
  • Studies undertaken to assess the effect of severe conditions on the drug product.
  • Studies undertaken to elucidate the intrinsic stability of the drug substance.

Pharmaceutical Analysis

Batch analysis of drug substance, drug products as per international pharmacopoeias i.e. USP, EP, BP, IP for following test :

  • Assay
  • RS
  • Dissolution
  • Polymorphism
  • Particle Size
  • Residual Solvents
  • Water content

Quantification of Polymorphs by XRD

Evaluation of polymorphic forms by powder XRD

  • Development of XRD method for identification of polymorphs
  • Polymorph screening in active ingredient
  • Polymorph identification in Drug products
  • Stability of polymorphs in drug substance and drug products.

Promas Research Labaratories Pvt. Ltd.

Promas has been synonymous with trust and quality for over 28 years. And now with Promas Research Laboratories we look forward to reinforce the same, Innovations results from research and experimentation.


USFDA FEI Number : 3011560035