Assay & impurities
- Active assay by HPLC and UPLC
- Related substances and degradation products
- Residual solvents by headspace GC
- Elemental impurities per ICH Q3D
- Nitrosamine impurity screening
- Identification by FTIR, UV and MS
Overview
Scope of pharmaceutical testing
Our pharmaceutical wing operates as a separate GLP-aligned area with its own instrumentation, its own document control and restricted access. Work is performed under IP, BP, USP and EP monographs, or under a validated in-house method where no monograph applies.
We are used by formulators without a full analytical bench, by manufacturers whose own laboratory is at capacity, and by nutraceutical brands whose contract manufacturer’s certificate of analysis they would rather verify independently.
Typical pharma submissions
- Tablets, capsules and softgels
- Oral liquids, syrups and suspensions
- Powders, granules and effervescents
- Topical creams, gels and ointments
- Herbal and Ayurvedic formulations
- Vitamin and mineral supplements
- Protein powders and sports nutrition
- Raw APIs and excipients
Scope
What we test
Physical & performance
- Dissolution, USP apparatus I and II
- Disintegration and friability
- Content and weight uniformity
- Hardness and thickness
- Loss on drying and water by Karl Fischer
- Particle size and bulk density
Stability studies
- ICH Q1A(R2) long-term and accelerated
- Intermediate and photostability (Q1B)
- Six chambers with 24×7 logging and alarms
- Scheduled pulls with a defined protocol
- Forced degradation and stability-indicating methods
- Shelf-life recommendation with statistics
Nutraceutical actives
- Vitamins A, D, E, K, B-complex and C
- Minerals and chelated forms by ICP-MS
- Curcuminoids, withanolides, boswellic acids
- Omega-3 profile and oxidation markers
- Protein content and amino acid profile
- Probiotic viable count (CFU) by plate count
Microbiological
- Microbial limits, USP 61 and 62
- Sterility testing under USP 71
- Bacterial endotoxins by LAL
- Antimicrobial effectiveness, USP 51
- Environmental monitoring of clean areas
- Water for pharmaceutical use
Regulatory support
- Method development and validation
- Method transfer and verification
- Out-of-specification investigation
- Comparative dissolution profiling (f2)
- Excipient and raw material qualification
- Analytical data packages for filings
Methods
Representative parameters and limits
A sample of the accredited scope. The full annexure, with every method reference and measurement uncertainty, is issued with your quotation.
| Parameter | Method | Typical LOQ | TAT |
|---|---|---|---|
| Assay by HPLC | In-house validated / monograph | 0.05% of label claim | 3 days |
| Related substances | USP / EP monograph, HPLC-PDA | 0.03% area | 4 days |
| Residual solvents (Class 1–3) | USP <467> headspace GC-FID | As per USP limits | 4 days |
| Elemental impurities | ICH Q3D / ICP-MS | 0.1 × PDE | 4 days |
| Dissolution profile, 6 units | USP <711> | Not applicable | 3 days |
| Water content | Karl Fischer, USP <921> | 0.05% w/w | 2 days |
| Microbial limits | USP <61> / <62> | 10 cfu/g | 6 days |
| Bacterial endotoxins | USP <85> gel clot LAL | 0.03 EU/mL | 3 days |
Questions
Frequently asked questions
We are an ISO/IEC 17025 accredited testing laboratory operating a GLP-aligned pharmaceutical wing. We are not a licensed manufacturing site and do not hold a manufacturing GMP certificate, no testing laboratory does. For regulatory filings we provide the accreditation certificate, the scope annexure, the method validation report and the instrument qualification records your assessor will ask for.
Yes. Six ICH-compliant chambers cover 25°C/60% RH, 30°C/65% RH, 30°C/75% RH, 40°C/75% RH, 2–8°C and a photostability unit. Temperature and humidity are logged continuously with alarm escalation to a duty officer, and the mapping report for each chamber is available to your auditor.
We support the analytical phase, re-examination of raw data, instrument suitability, repeat analysis on a fresh portion under a written protocol, and a documented laboratory investigation report. The manufacturing phase of the investigation stays with you, as it must.
We measure what is present and report it against what the label declares. If the measured active is below the declared claim, that is what the report says. We will not issue a certificate worded to imply a compliance decision that the data does not support.
Formulation details are held in a restricted LIMS record accessible only to the assigned analyst, the reviewer and the technical manager. Staff sign individual confidentiality undertakings and we will sign your NDA before you send anything. We never disclose client identity, even to confirm or deny a relationship.
Planning a stability study?
Chamber slots are allocated monthly and the protocol has to be right before the first pull. Talk to our stability coordinator before you commit a batch.