SIMA LABS is NABL accredited and approved for excipients testing in compliance with FSSR, BIS, and leading global pharmacopeial standards including IP, USP, BP, EP, and JP. Our approvals ensure that all test reports are legally valid for domestic regulatory submissions, vendor audits, and international market entry.

We offer complete quality assessment of pharmaceutical excipients to verify their identity, purity, safety, and functional performance as per pharmacopeial requirements.

Scope of Testing:

• Excipients Covered:

  • Binders (e.g., PVP, starch, cellulose derivatives)

  • Fillers/Diluents (e.g., lactose, MCC, mannitol)

  • Disintegrants (e.g., croscarmellose sodium, crospovidone)

  • Lubricants (e.g., magnesium stearate, stearic acid)

  • Preservatives, colorants, sweeteners, and flavoring agents

Parameters Tested:

• Identification & purity testing

• Loss on drying / moisture content

• Residual solvents & elemental impurities

• Microbial limits testing

• pH, viscosity, and functional performance tests

• Particle size distribution and bulk density

Technology Used:

• HPLC, GC, FTIR, UV-Vis, ICP-MS, ICP-OES, Particle Size Analyzer

• Microbiological testing using state-of-the-art facilities

Regulatory Compliance:

• Indian Pharmacopoeia (IP)

• United States Pharmacopoeia (USP)

• British Pharmacopoeia (BP)

• European Pharmacopoeia (EP)

• Japanese Pharmacopoeia (JP)

With validated methods, skilled analysts, and stringent quality controls, SIMA LABS ensures excipients meet all quality benchmarks for safe and effective pharmaceutical formulations.