Today, in the era of competitive globalization, drug and pharmaceutical manufactures face humongous pressures to keep production pipelines full, manage research and development costs, supply more drugs to the market and build as well as increase their brand value. To make a headway in this environment, we can assist you with our knowledge, skills, excellency, infrastructure and resources to propel inventions and speed up drug development and quality control processes.

Whether its a single test on your product or an entire quality control solution, we are geared to assist you in delivering your product at an extraordinary speed into the market.
Whether it be bulk drugs, intermediates or finished products, our testing facility will cater to your needs. Our services are customized to meet sponsor’s individual requirement accurately and effectively with the context of regulatory guidelines.

Our state of-the-art FDA approved laboratory at Ahmedabad supports the testing and analysis of wide range of products as per National and International standards and specific customer requirements.
At ARL, we provide a fast, economic and reliable services in the fields of pharmaceutical, chemical and nutraceuticals testing.

  • Pharmacoepial Testing
  • Raw Materials and excipient analysis
  • Method Development and Validation
  • Comparator Testing
  • Extractables and Leachables

Pharmacoepial Testing
Drug products and drug substances can be analysed as per the latest pharmacopoeia (USP, BP, EP, IP. JP) or customer specified procedures and specifications. All the methods are used only after verifications or validations.
Laboratory is equipped with a wide range of analytical instruments like HPLC,GC with headspace, FT-IR, UV Visible spectrophotometer, Dissolution and Disintegration apparatus, Friability tester etc.

Raw Materials and Excipients Analysis
Drug raw materials and excipients can be tested as per latest Pharmacopoeia(USP, BP, EP, IP, JP), including the following tests:

  • Identification Tests
  • Organic Volatile Impurities and Residual Solvents as per USP
  • Pharmaceutical Grade Water testing as per USP and BP

In case of non-Pharmacopoeial raw materials and excepients, the development and validation of test procedures are also undertaken.

Analytical Method Develpoment and Validation
We offer analytical method development and validation services in compliance with current national as well as international guidelines. The validations are done for all the parameters as per regulatory requirements. ARL is equipped with the following analytical techniques:

  • HPLC with UV-Detector
  • GC with headspace and FI detector

Method development is undertaken for:

  • Assay
  • Dissolution
  • Impurities
  • Residual solvents
  • Physicochemical tests

We also undertake complete impurity profiling of pharmaceuticals.

Comparision Testing
We offer analytical support to evaluate new products in development with marketed products of the same class. Services include:

  • Identification of various drugs
  • Assay (chromatographic purity)
  • Dissolution, disintegration and frialbility
  • Content uniformity and
  • Impurity profiling

Extractables and Leachables

Extractables and leachables are chemicals that can be released/migrated from primary and secondary packing materials such as containers, container liners, closures, closure liners, stopper over-seals, container inner seals, administration ports, overwraps, container labels, administration accessories and shipping containers.
Typical contaminants include phthalate esters, cyanides, nitrosamines, benzopyrenes, trace metals etc.
ARL can determine the potential contaminants in various drug substances and drug products with the help of following:

  • HPLC
  • GC
  • FTIR