Part of the Cotecna Group

Pharmaceuticals Testing

Shiva's advanced pharmaceutical product testing laboratory in Bangalore, India, delivers cGMP compliant and USFDA approved analytical services for clients in the industry.

Any pharmaceutical product manufacturer requires a stringent quality control, which is one of the pre-requisites to meeting regulatory compliance. A significant portion of the cGMP regulations, and all pharmacopeia methods such as USP, IP, EP, JP, BP, and in-house methods, pertain to the quality control testing of products. Shiva provides expert analytical services in all areas of testing from raw materials, excipients, APIs, Bulk drugs, intermediates, to finished products. SHIVA's sophisticated pharmaceutical testing lab operates as an extension of your QC and Analytical R&D laboratories.

Data Integrity is handled in compliance with (21 CFR Part 11) regulations subsections (a) to (g). All the data acquisition systems are linked through ECM software ensuring data security from generation till archival of electronic data.

Our scope of services include:

Pharmacopeial Testing

  • Raw materials
  • Excipients
  • Active pharmaceutical ingredients(APIs)
  • Bulk Drugs
  • Finished products
  • Herbal product analysis
  • Medical Devices"

Analytical R&D

  • Analytical method development and validation as per the ICH guidelines
  • Development of Stability-indicating methods
  • Impurity identification and quantification by LC-MS/MS and GC-MS/MS
  • Method Development and Validation for Heavy metal estimation by AAS, ICP-OES and ICP-MS
  • Cleaning validations
  • Dissolution studies
  • Extractable and Leachable studies
  • Stability studies as per the ICH guidelines
  • Azido impurities testing in APIs & Formulations
  • Residual Genotoxic Impurities in APIs & Formulations
  • Nitrogen and Compressed air analysis under cGMP
  • Cleanroom validation and qualification

In addition to the Pharmacopeial testing of finished products, some of the analysis carried out as per validated methods on raw materials are:

Chemical Testing

  • Residual Solvents
  • Residual Ethylene Oxide, Ethylene Glycol & Ethylene Chlorohydrin
  • Heavy Metal analysis by AAS, ICP-OES and ICP-MS
  • Physico-chemical properties
  • BET surface area (non GMP)

Request an Analysis

To learn more about our testing services, request an analysis for your business, and discover how partnering with Shiva can benefit your organization, please feel free to contact us.

 

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About Shiva Analyticals

Certifications & Accreditations

Shiva Analyticals is an ISO 9001 certified and ISO 17025 accredited analytical laboratory based in Bangalore, India, to provide testing services for a wide range of food, agricultural, pharmaceutical, mineral and petroleum products.

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