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Analytical Testing

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Analytical Testing

Robust analytical testing, also known as materials testing, is a vital component of the drug manufacturing program. It holds the power to determine the progress of each stage, making it a make-or-break factor for the overall development process.

At Analys, we provide a suite of customized analytical testing protocols that empower our clients to accelerate their drug release programs and gain an early-to- market advantage. It's time to focus on your core expertise and entrust all your analytical testing requirements to Analys, a company whose expertise has been time and again proven.

We offer the following best-in-industry analytical testing protocols that cater to all your requirements:

Quality Control Tests
  • Applicable to raw materials, intermediates, active pharmaceutical ingredients (APIs) and Drug products
  • Drug Assays
  • Related Substance Studies
  • Stability Analysis
  • Limit Analysis
  • Analysis of Residual Solvents
  • Physicochemical Characteristics of APIs
  • Testing of GTI’s & Nitrosamine Impurities.
Pharmacopeial Studies (USP, BP, EP, JP, IP)
  • Analysis of Excipients
  • Analysis of Elemental Impurities
  • Compliance with Current Regulations
Solid State Drug Characterization
  • State-of-the-art technologies utilized, including X-ray Diffraction (XRD), Fourier Transform Infrared Spectroscopy (FTIR), Malvern Particle Size analyser (PSD), Surface Area Analyser (SSA). Thermo Gravimetric Analysis (TGA), Differential Scanning Calorimetry (DSC), and Modulated DSC
Trace Metal Analyses and Functional Analysis
  • Cutting-edge techniques employed, such as Inductively Coupled Plasma-Mass Spectrometry (ICP-MS), Ion Chromatography (IC), and Atomic Absorption Spectroscopy (AAS)
  • Ability to detect trace elements down to minute quantities of part per billion (ppb)
Genotoxic impurities (GTI’s) & Nitrosamine impurities
  • State-of-the-art technologies utilized, including LC-MS/MS, LC-HRMS, GC-MS/MS
  • Ability to detect GTI’s & Nitrosamines down to minute quantities of part per billion (ppb)
Extractable and Leachable Testing
  • Growing in importance to prevent potentially harmful impurities from contaminating the finished pharmaceutical product
  • Protocols encompass Gas Chromatography Mass Spectrometry (GC-MS/MS) for volatile and semi-volatile impurities, Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS) for non-volatile impurities, and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for elemental impurities
  • Personalized E & L studies tailored to meet client requirements, covering not only parenteral and injectables but also solid and liquid containers, packaging materials, and material compatibility studies

At Analys, we prioritize accuracy, safety, efficacy, and stability. Our team of scientists utilizes advanced technologies, state-of-the-art instruments, and industry-standard protocols to ensure that your analytical testing needs are met with excellence. Trust us to be your partner in achieving the highest standards of quality and regulatory compliance in the pharmaceutical industry.

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Hyderabad

Analys Lab Private Limited (Unit-II),

4th Floor, Plot No. 47, IDA, Balanagar – 500037, Hyderabad, Medchal – Malkajgiri Dist, Telangana, India.

Analys Lab Private Limited (TIE Campus),

Plot No. B-10, Technocrat Industrial Estate, Phase-ll, Balanagar - 500037, Hyderabad, Medchal Malkajgiri Dist, Telangana, India.

Telephone

+91 040 23721300

+91 040 29323302

Mobile

+91 897-760-5342

+91 897-760-5343

E-Mail Us

bd@analyslab.com


Visakhapatnam

Analys Lab Private Limited (Unit-I),

SY No: 71/1, 71/2, 71/6 and 71/11, Lankelapalem, Parawada Mandal, Anakapalli District – 531021, Andhra Pradesh, India.

Telephone

+91 08912850101

Mobile

+91 910-082-9571

E-Mail Us

bd.u1@analyslab.com

Analys Lab one of the fastest growing cGMP/cGLP contract analytical testing laboratories in India, is dedicated to providing swift, accurate, and meticulous analytical testing solutions to the global pharmaceutical industry.

State-of-the-art facilities located in Hyderabad and Vishakhapatnam, India, Analys Lab sets an international standard for quality and excellence.

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