Pharmaceuticals & Finished Dosage Forms
Defensible Analytical Data for APIs, Formulations & Regulatory Filings
Satvam Research provides comprehensive cGLP and 21 CFR Part 11 compliant analytical testing for pharmaceutical manufacturers across Gujarat and Maharashtra. Operating an 8,500 sq. ft. laboratory on NH-48 in Vapi, we deliver compendial monograph testing (IP, BP, USP, EP, JP), ICH Q2 method lifecycle validation, ICH Q3D trace elemental impurities (ICP-OES), GC-HS residual solvents, and walk-in stability chamber studies.
Pharmaceuticals Highlights
Meeting Global Standards in Pharmaceuticals
In the highly regulated pharmaceutical sector, analytical data must withstand stringent audits from global regulatory authorities including the US FDA, MHRA, WHO, CDSCO, and state FDAs. Satvam Research operates with computerized chromatography data integrity, dual-level QA sign-offs, and calibrated Shimadzu instrumentation to guarantee defensible test results from raw material clearance to commercial batch release.
Key Governing Specifications & Pharmacopoeias
Every test certificate (CoA) issued by Satvam Research undergoes dual-level scientific validation with complete electronic record archives.
Applicable Testing Services for Pharmaceuticals
Direct access to our dedicated analytical workflows configured for this vertical.
Analytical Method Lifecycle (ICH Q2)
Tailored method development, validation, verification, and technical transfer.
Related Substances & Assay (HPLC)
Chromatographic purity, organic impurities, and finished dosage form assay.
Trace Elemental Impurities (ICP-OES)
Sub-ppb quantification of Class 1, 2A, 2B, and 3 heavy metals per ICH Q3D.
Residual Solvent Analysis (GC-HS)
Headspace volatile organic solvent screening per USP <467> and ICH Q3C.
Stability Testing & Shelf-Life Studies
Real-time and accelerated stability storage with automated datalogging.
Cleanroom Microbiology (MLT)
Class 10,000 cleanroom bioburden, microbial limit testing, and pathogen absence.
Comprehensive Parameter Testing Menu
Each discipline is executed on calibrated instrumentation under rigid quality management protocols.
Assay & Chemical Evaluation
- Active Ingredient Potency / Assay by HPLC / Titrimetry
- Related Substances & Degradation Products Profiling
- Enantiomeric Purity & Chiral Chromatography
- Content Uniformity & Blend Uniformity Evaluation
- Loss on Drying (LOD) & Karl Fischer Water Content
Safety & Impurities Screening
- ICH Q3D Elemental Impurities by ICP-OES (Pb, As, Cd, Hg, etc.)
- USP <467> Class 1, 2, 3 Residual Solvents by Headspace GC
- Heavy Metals Chemical Semi-Quantitative Verification
- Sulfated Ash / Residue on Ignition
Microbiological & Environmental
- Microbial Limit Testing (TAMC / TYMC)
- Pathogen Absence: E. coli, Salmonella, P. aeruginosa, S. aureus
- Bacterial Endotoxin Testing (LAL)
- Cleanroom Environmental Monitoring Bioburden
Instrumentation Configured for Pharmaceuticals
Frequently Asked Technical Questions
Regulatory guidelines, turnaround times, and sample handling for Pharmaceuticals
QHow does Satvam Research guarantee 21 CFR Part 11 compliance for pharma batches?
All computerized analytical workstations operate under LabSolutions chromatography software configured with role-based access controls, unalterable system audit trails, automated password aging, and secure server archiving with dual QA sign-off.
QCan Satvam Research handle stability samples under Zone IVb conditions?
Yes. Our facility maintains calibrated climatic chambers operating continuously at 25°C/60% RH, 30°C/65% RH, and 40°C/75% RH (Zone IVb) with multi-point automated temperature and humidity datalogging.
QWhat sample volumes are needed for compendial release testing?
For complete IP/BP/USP monograph release, 10–20g of active substance or 50–100 dosage units (tablets/capsules) are typically required, accompanied by sample safety data and COA references.
Ready to Initiate Pharmaceuticals Testing?
Submit your sample parameters or request a formal quotation tailored to your batch volume and compendial requirements.