Pharmaceutical testing services in Pune

Chemical and instrumental analysis, microbiology testing, analytical method validation, computer system validation and impurity standards, all under one NABL accredited (ISO/IEC 17025) and FDA approved laboratory. Methods follow IP, BP, USP, EP and ICH guidelines.

Services

Four service lines, one accredited lab

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15 SERVICES

Chemical & instrumentation

For all types of industries, from APIs and excipients to finished formulations and packaging.

  • Method development & validationICH Q2(R1) · USP <1225>
  • Method verification & transferUSP <1224> <1226>
  • Nitrosamines by GC-MS/MSTrace level
  • Elemental impuritiesUSP <233> · ICP-MS
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  • Packaging material testingUSP <661.1> <661.2>
  • 5-batch analysis & batch release
  • API & excipient testingUSP · BP · IP
  • Residual solventsUSP <467>
  • Formulation development studies
  • Stability testingICH Q1
  • Dissolution studies
  • Forced degradation studies
  • Pharmacopoeial testing of materials
  • Cleaning / residue method development & validation
  • Complete water analysis
10 SERVICES

Microbiology

Microbial quality, sterility and validation work for products, water and environment.

  • Method development & validationMLT · BET · Sterility · PET
  • Microbial limit testMLT
  • Sterility test
  • Bacterial & depyrogenation endotoxinBET · DET
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  • Cleaning validations
  • LBPC
  • Biological assay
  • Growth promotion testGPT
  • Water system validationPhase I · II · III
  • Environmental monitoring
5 SERVICES

Computer system validation

Validation and assurance for laboratory and GxP computerised systems.

  • Computer system validationGAMP 5
  • Computer software assurance verificationCSA
  • Challenge testing
  • Gap & risk assessments
  • Customer-specific requirements
4 SERVICES

Impurity & standard supply

Custom-made and ready-stock impurities and standards for QC and R&D.

  • Custom impurity manufacturing
  • Custom standard manufacturing
  • Quality systemISO 17025 · ISO 17034
  • Ready-stock impuritiesQuick dispatch
FAQ

Questions about our testing laboratory

Is Rajaswa a NABL accredited testing laboratory?

Yes. Rajaswa Pharmaceuticals is accredited by NABL to ISO/IEC 17025:2017 in the field of testing (certificate TC-17877, valid until April 2030). The laboratory is also approved by FDA Maharashtra under Form 37 for drugs and COS-23 for cosmetics.

Where is the laboratory located?

The laboratory is at Lavale Phata, Pirangut, Pune, Maharashtra 412115. We accept samples from pharmaceutical and cosmetic manufacturers across India by courier or hand delivery.

Which tests do you perform?

Assay, related substances and impurities by HPLC and UPLC, LC-MS and GC-MS work including nitrosamines, residual solvents by headspace GC (USP <467>), elemental impurities, dissolution, stability studies, water and packaging material testing, and microbiology such as MLT, sterility, BET and environmental monitoring.

Do you test cosmetics and Ayurvedic products?

Yes. We hold FDA Maharashtra COS-23 approval for testing cosmetics and their raw materials, and our ISO scope covers allopathic, Ayurvedic and cosmetic products.

Do you provide analytical method validation?

Yes. We develop, validate, verify and transfer analytical methods as per ICH Q2, USP <1225>, <1224> and <1226>, including cleaning method validation and forced degradation studies.

What is the turnaround time?

Our standard turnaround time is 7 days from sample receipt. Send your specification and test list and we will confirm the timeline and quotation.

Need a test done at an accredited lab?

Send your product, test list and specification. We reply with a quotation and turnaround time.

Send a test enquiry